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Page I 1
LOTUS PHARMACEUTICALBUILDING A REGIONAL LEADER
November 2018
Page I 2
Safe Harbor Statement
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.
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Page I 3
Table of Contents
Page I 3
Company Overview
3Q 2018 Financial Results and Operational Progress Highlights
Profitable Growth Strategy
Page I 4Page I 4
COMPANY OVERVIEW
Page I 5
LOTUS PHARMACEUTICAL IS AN APAC GENERICS LEADER
1
Page I 5
Founded in 1966Lotus Pharmaceutical is among Taiwan’s largest specialty-generic drug
developers and one of the early movers to export to the US market since 2011
Its portfolio includes CNS, CVS, oncology, women health, anti-obesity, respiratory
and pain relief in forms of tablet, capsule and soft gel capsule
The rising generic leader in APACLotus is positioned as a regional platform for Alvogen Group (63.4% holding in
Lotus) since Aug 2014 through private placement, sharing global commercial,
R&D and regulatory infrastructure
The current operation scope of Lotus spans across Lotus Taiwan’s domestic
business, Alvogen Korea’s domestic business, Alvogen Pharma India’s CRO
business, and export businesses
Capital market milestone
Lotus Pharmaceutical (1795. TWO) has been listed on Taipei Stock Exchange
since 2010 and became a Taiwan Market Biotechnology and Medical Care Index
stock in July 2017 and a TPEx 50 Index stock in April 2018
Extraordinary quality management Lotus’ R&D and manufacturing facilities in Nantou is the only one in Asia that’s
approved by US FDA, EU EMA, Japan PMDA and TFDA PIC/S
1
2
3
4
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70+ Generic products in pipeline
2 Biosimilar products in pipeline (mab’s)
8 MAs in the US; 27 MAs in Europe;
10 MAs in Japan; 1 MA in China
A FAST GROWING GENERICS & SPECIALTY PHARMACEUTICAL POWERHOUSE
Lotus facts
Page I 6
1000+ Employees
3 Manufacturing and R&D Centers
300+ Marketed products
150+ Submissions since 2012
10%
18%
23%
49%
Lotus Taiwan EmployeesTotal: 402
G&A
R&D
S&M
Plant
10%
8%
48%
34%
Alvogen Korea Employees Total: 531
G&A
R&D
S&M
Plant
Page I 7
2015-2016
POST MERGERINTEGRATIONPHASE
2017-2018
INITIALGROWTHPHASE
2019~
EXPLOSIVEGROWTHPHASE
LOTUS SEES TANGIBLE PROGRESS TOWARD TRANSFORMATION
Page I 7
• Upgrade Nantou plant
• Change management team
• Reshape Portfolio and
pipeline
• Adjust sales and marketing
strategy
• Resolve legacy issues
• Build key franchises in each
APAC market
• Focus on specialty driven
markets
• Continue to increase
operational efficiency
• US and EU export revenues to
significantly grow
• High value products and
economies of scale to drive up
gross margin
• Strengthen balance sheet
• Invest in key franchises and
become category leader
• More aggressive CAPEX plan
Page I 8
WE STABILIZED IN 2017 AND HAS LAID A SOLID GROWTH GROUND
8
-1000
0
1000
2000
3000
4000
5000
6000
7000
2014 2015 2016 2017 9M2018
4 Year Trend (NT$mn)
Rev. Gross Profit Operating Profit
50%
59% 56% 48%
-19%
8% 4% 8%
48%
7%
Page I 9Page I 9
3Q 2018 FINANCIAL RESULTS
AND OPERATIONAL PROGRESS
HIGHLIGHTS
Page I 10
CONTINUOUS MARGIN IMPROVEMENT AND HISTORICAL-HIGH NET INCOME
BEFORE TAX REPORTED DURING THE QUARTER
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MORE CASH GENERATED FROM OPERATIONS ATTRIBUTABLE TO PROFITABLE
OPERATING RESULTS AND IMPROVED WORKING CAPITAL
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Page I 12
APAC MARKET FRANCHISE SOLIDIFICATION CONTINUES
Page I 12
INN Indication YTD (NT$mn) YoY (%) Remarks
1 Goserelin (Zoladex) Breast cancer 乳癌 420.8 +4%Exclusive marketing alliance with
AstraZeneca KR; launched Oct’16
2 Rosuvastatin/EzetimibeCardiovascular
降血脂與膽固醇396.0 +76% Dosage improved to 1/day
3 Sarpogrelate Anticoagulant 抗凝血 356.3 +18% FDC; launched in 1Q16
4Calcium Polystyrene
SulfonateNephrology 腎臟病 253.0 6%
5 Seroquel (Quetiapine) Schizophrenia 精神分裂症 220.4 -5%Exclusive marketing alliance with
AstraZeneca KR; launched Oct’15
6 Desogestrel/EE (Mercilon)Oral contraceptive
口服避孕藥213.4 +4%
Acquired from Bayer;
launched in May’16
7 Phentermine Anti-obesity 減肥 157.7 -17%
8 Bicalutamide Prostate cancer 攝護腺癌 157.2 -6%Exclusive marketing alliance with
AstraZeneca KR; launched Oct’16
9 Anastrozole (Arimidex) Oncology 癌症 148.6 +7%Exclusive marketing alliance with
AstraZeneca KR; launched 4Q’16
10 Zoledronic Acid (Aclasta) Osteoporosis 骨質疏鬆症 127.2 +11%Acquired from Novartis; launched
Apr’17; TW product
11 Phendimentrazine Anti-obesity 抑制食慾 121.2 -15%
12 Orlistat Anti-obesity 減肥 111.2 -3%
13 Methylprednisolone Anti-infection 抗感染 70.5 +41% Tender driven
14 Trazodone Anti-depression 憂鬱症 48.4 +49% CN product
15 Mifepristone Hormonal 賀爾蒙藥 44.0 +41% TW product
13
SOLID EXECUTION ON CORE BUSINESS YEAR-TO-DATE
• Top 15 products generated >60% of
total sales and grew 7.5% YoY
• Net cash generated from operations
were NT$661.8mn, displaying a
38% increase
• Resolved IP level legal issues of
Buprenorphine/Naloxone for the US
14
DRIVING GROWTH WITH INHOUSE PIPELINE
• Pending approval: Budesonide ER
(US FDA), Methotrexate (US FDA),
Lenalidomide(US FDA, still in 30
month stay), Vinorelbine (ROW),
LP149 (ROW), Acarbose (CFDA)
• Approved in 9M2018 and preparing
for launch: Lenalidomide (ROW),
Gefitinib (ROW)
• Approved in 9M2018 and launched:
Norethisterone/Ethinylestradiol
ULD (JP), Varenicline SR (KR),
Bazedoxifene HCL (KR)
• Late R&D phase: LP149 (US),
LP173 (ROW)
Page I 15Page I 15
PROFITABLE GROWTH STRATEGY
IN A RAPIDLY CHANGING ENVIRONMENT, WHAT MAKES US DIFFERENT 16
ENVIRONMENT
• Shifting demographics
• Political and regulatory
volatility
• High impact therapies for
high demand patients
RESOURCES WE EMPLOY
• Strong collaborations and
partnerships
• Plant and equipment
• Talented employees and
Alvogen culture
HOW WE STAND OUT
• Commitment to internal and
external innovation
• Strong franchises that
enable leadership
• Relentless focus on unmet
medical needs
Page I 17
OUR GOAL FROM NOW TILL 2020– GROWTH, MARKET SHARE, REINVESTMENT
Back to Basics
Value Differentiation
Geared Up For The Future
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Profitable
Growth
Page I 18Page I 18
BACK TO BASICS
• Strong Portfolio
• Best Service
• Best Quality
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ONLY VERY FEW SELECTED CATEGORIES WILL GROW, AND WE ARE THERE
Page I 19
As a fast follower, what does innovators’ trend tell us?
• Oncology drugs are dominating US approvals
• Global pharma is growing at 10.8% YoY by sales value and nearly 60% of that growth comes
from oncology related and CVS according to IQVIA
• Small volume, high ASP is a must-play for pharma
24
8
2
6
8
10
11
9
19
59
16
9
14
18
13
13
10
16
Cancer
Diabetes
Respiratory
Infections viral
Other infections
Cardiovascular
Genetic
Immunology
CNS/Pain
2012-2017 2007-2011
‘17 TAM +21% YoY
US FDA new drug approval trend
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28%
22%
4%3%2%
41%
WE CAN NOT AFFORD TO GO AFTER GENERAL GENERICS ANYMORE
Page I 20
Balanced contribution from 5 main therapeutic areas
18%
19%
9%16%
8%
30%
2017A
What is our portfolio strategy?
• Complex products
• High-barrier oncology products
• OTC and lifestyle products
• Local/regional partnerships and big pharma tail-end brands
15%
23%
9%17%
9%
27% Anti-obesity
CVS
CNS
Oncology
Women health
Others
9M 20182016A
Continue to refine margin profile based on this breakdown
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BEST QUALITY MAKES US THE MOST PREFERRED PARTNER OF OUR CUSTOMERS
Lotus quality record
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Korea – Gongju Plant Korea – Hyangnam Plant Taiwan – Nantou Plant
Products
• Tablets
• Coated tablets
• Hard capsules
• Powders, granules
• Tablets
• Coated tablets
• Hard capsules
• Powders, granules
• Tablets
• Coated tablets
• Softgel capsules
• Hard capsules
Capacity• Max capacity at 500mn
units of tablets
• Max capacity at 800mn
units of tablets
• Max capacity at 1.5bn
units of tablets
Accreditation • KGMP compliant • KGMP compliant
• US FDA, EU EMA, Japan
PMDA & TFDA PIC/S
approved
• Planning for China CFDA
inspection
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LOTUS PHARMACEUTICAL PROVIDES BEST SERVICE IN EVERY ASPECT
1
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Growing key markets sales team
70 in-house sales in Taiwan and 299 in-house sales in Korea, covering drug
stores, clinics, general and community hospitals
The best R&D and manufacturing partner
We specialize in formulation development of high potency compounds, phase I,
and other technical services to fulfill the gap among critical CDMO projects.
Achieving vertical integration through CRO capabilities in India
Norwich Clinical Service provides biostudy, clinical and pharmacovigilance
services to Lotus & Alvogen Group and 3rd party customers, and holds an
oncology center in Bangalore, India
1
2
3
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VALUE DIFFERENTIATION
• High Value Pipeline
• Short Time to Market
• Leader in Special Dosage
Page I 24
Generic Name Indication
IQVIA
market size
(US$mn)
Formulation BE & CT Submission Approval
1Budesonide
ERGI 結腸潰瘍 US: 200
2Buprenorphine/
Naloxone
OUD
戒類鴉片毒癮US: 2,000
3 MethotrexateChemo
癌症US: 340
4 LenalidomideMultiple
Myeloma
血癌US: 7,000
5 Vinorelbine
Breast cancer
and NSCLC
乳癌與非小細胞肺癌
EU: 130
6 LP149 ROWWomen health
女性保健EU& APAC:
110
7 LP650GIST; inhibitor腸胃道間質腫瘤
EU & APAC:
609
THE EMERGING NON-INDIAN PHARMA WITH FIRST WAVE PURSUIT GLOBALLY
To be launched in 2018 - 2021
NO BE
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PIV; non-infringement, CRL
PIV; non-infringement
CRL
Focusing high value innovation for patients and customers
NO BE
PIV; sued in US; US technical review done
Page I 25
Generic
NameIndication
IQVIA
market size
(US$mn)
Formulation BE & CT Submission Approval
9 LP173
Late stage
onco for soft
tissues
sarcoma +
renal cell
carcinoma
腎癌、上皮細胞癌、軟組織
肉瘤(皆非一線)
Global: 792
10 LP337
Late stage
hepatocellular
carcinoma,
renal cell
carcinoma,
thyroid
carcinoma
晚期肝細胞癌、晚期腎癌、分化型甲狀腺癌(皆非一線)
EU & APAC:
470
11 LP149 USWomen health;
女性保健FTF
To be launched in 2021 - 2024
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200mg
400mg
Page I 26
Generic Name Indication
IMS
Market Size
(US$mn)
Formulation BE & CT Submission Approval
1 Varenicline SRSmoking Cessation
戒菸37
2Bazedoxifene
HCL (FDC)
Osteoporosis
骨質疏鬆18
3Bazedoxifene
(FTF)
Osteoporosis
骨質疏鬆8
4AK-R309
(FTF)
OAB
膀胱過動症24
THE LEADING SPECIALTY IMD DEVELOPER IN KOREA CONTINUES TO AIM HIGH
To be launched in 2018 - 2020
Page I 26
IMD in Korea is similar to US 505b2 filing path with much condensed development and regulatory time
Page I 27
TIME TO MARKET IS ESSENTIAL AS MARKET SENTIMENT CHANGES
FDA is pro-active on
• Guidance on complex generics
• A basket of products without generics
• Prioritize FTM generics
Page I 27
Increased competitions amid generics market, yet FTM is always favored
Source: FDA
Page I 28
LOTUS PHARMACEUTICAL IS THE REGIONAL LEADER IN SPECIAL DOSAGE
Soft Gel Manufacturing
• Safety, efficacy, bioavailability and solubility issues dominated
as the most significant factors in developing drug formulations
• According to BCS classification, ~70% of new chemical
entities (NCE) are class 2 or 4
• Lotus is the regional expert in delivering low-dose cytotoxic
and potent APIs as it can ensure dose uniformity, which is a
challenge with traditional tablet manufacturing and powder
capsulation processes
• Investment in dedicated manufacturing area starting 2009 and
current capacity at 500mn capsules / year
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Page I 29Page I 29
GEARED UP FOR THE FUTURE
• Emerging Headway in The China Storm
• Ongoing Investment In Specialty R&D
Page I 30Page I 30
10+ molecules in discussion
WE ARE MAKING GOOD PROGRESS IN THIS MARKET WITH RISING QUALITY AWARENESS
01BE study data integrity, tax reform, two-invoice system, and recent vaccine and API
scandal have led to increasing portfolio acquisition activities in China
02We have set up BD and regulatory teams in China in 2017 and identified several
molecules for potential partnerships with Chinese CSO and pharmaceuticals
03Expect to launch ~2 significant products in China before 2020 in addition to at least 3
new submissions to take advantage of climate change
4+ partners in DD phase
Page I 31Page I 31
CONTINUE BUILDING “SPECIALTY” GENERICS FROM OUR POSITION OF STRENGTH
31
Molecule Exclusivity Status Forum & Success Rate How Not To Infringe
Orphan Drug: 7Y Delaware Seek IPR invalidation
Average NCE: 3Y New Jersey Polymorphic form redesign
Pediatric: N+6M Texas Composition redesign
Not NCE: None Label carve-out
• We focus on BCS Class 2 & 3 projects which
entail complicated in-vivo bioavailability and
bioequivalence studies
• We deploy softgel as a platform for BCS Class
2 & 4 projects
Small volume, High value Complex Molecules
Potential high market share from Complex IP Landscape
Page I 32
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
BEST IN CLASS CUSTOMER SERVICE
HIGHEST QUALITY
HIGH OPERTIONAL EFFICIENCY
TARGETED PORTFOLIO
ONLY THE BEST PEOPLE