lotus pharmaceutical · 2018-03-29 · osteoporosis 骨質疏鬆 18 3 ak-r308 osteoporosis...
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LOTUS PHARMACEUTICALBUILDING A REGIONAL LEADER
Mar 2018
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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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Table of Contents
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Company Overview
FY2017 Financial Results
Operating Remarks And 2017 Achievements Highlights
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COMPANY OVERVIEW
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LOTUS PHARMACEUTICAL IS AN APAC GENERICS LEADER
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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 a reverse merger, and leverages Alvogen Group’s
cross-border reach to scale up
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
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
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3
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70+ Generic products in pipeline
2 Biosimilar products in pipeline (mab’s)
8 MAs in the US; 25 MAs in Europe;
9 MAs in Japan; 1 MA in China
A FAST GROWING GENERICS & SPECIALTY PHARMACEUTICAL POWERHOUSE
Lotus facts
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1000+ Employees
3 Manufacturing and R&D Centers
300+ Marketed products
150+ Submissions since 2012
11%
19%
23%
47%
Lotus Taiwan EmployeesTotal: 380
G&A
R&D
S&M
Plant
9%7%
52%
32%
Alvogen Korea Employees Total: 549
G&A
R&D
S&M
Plant
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2015-2016
POST MERGERINTEGRATIONPHASE
2017-2018
INITIALGROWTHPHASE
2019～
EXPLOSIVEGROWTHPHASE
LOTUS SEES TANGIBLE PROGRESS TOWARD TRANSFORMATION
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• Upgrade Nantou plant
• Change management team
• Reshape Portfolio and
pipeline
• Adjust sales and marketing
strategy
• Resolve legacy issues
• Solidify local portfolio
through key launches
• Focus on specialty driven
markets
• Continue to increase
operational efficiency
• Export revenues to
significantly grow from
several successful key PIV-
challenges
• High value products and
economies of scale to drive
up gross margin
• Strengthen balance sheet
• Invest in key franchises and
become category leader
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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
4 Year Trend (NT$mn)
Rev. Gross Profit Operating Profit
50%
59% 56% 48%
-19%
8% 4% 8%
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4Q AND
FY2017 FINANCIAL RESULTS
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OPERATING PROFIT REACHED HISTORICAL HIGH IN 2017
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Unit: NT$000 2017 % 2016 % YoY
REVENUE $6,423,760 100 $5,902,566 100 8.83%
COGS 3,344,086 52 2,574,537 44 29.89%
GROSS PROFIT 3,079,674 48 3,328,029 56 -7.46%
OPEX
S&M 1,546,610 24 1,904,732 32 -18.80%
G&A 680,452 11 726,739 12 -6.37%
R&D 329,523 5 452,175 8 -27.12%
Total OPEX 2,556,585 40 3,083,646 52 -17.09%
OPERATING PROFIT 523,089 8 244,383 4 114.04%
NON-OP INCOME & EXP
Finance costs -259,659 (4) -277,902 (4) -6.56%
Others -52,616 (1) 52,779 1 -199.69%
Total non-op expenses, net -312,275 (5) -225,123 (3) 38.71%
INCOME BEFORE TAX 210,814 3 19,260 1 994.57%
INCOME TAX EXPENSE -161,996 (2) -111,805 (2) 44.89%
NET ERANINGS (LOSS) 48,818 1 -92,545 (1) NA
EPS $0.03 -$0.56 NA
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OPERATING REMARKS AND 2017
ACHIEVEMENTS HIGHLIGHTS
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80.6%
10.3%
6.5%
2.6%
2017 IS THE TIPPING POINT OF GEOGRAPHIC DIVERSIFICATION
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2016FY 2017FY
While Korea remains our backbone thanks to its market potential and favorable
regulatory environment, Lotus successfully diversified its geographic exposure by
growing Taiwan domestic and export market
85.4%
8.0%
2.6% 4.0%
Korea
Taiwan
Export
India CRO
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YOY GROWTH LANSCAPE ACROSS MARKETS
• Trazodone milestone fee from a Chinese partner
• Shipment of Temo, LVT and CAC to US
Export +173%
• Eased anti-obesity competition in 2H17
• Entry into oncology distribution market
KR +3%
• Successful launch of Aclasta injection
• 65% rev. growth from hospital channels thanks to new launches and oncology share gain
TW +40%
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NEW PRODUCT LAUNCHES IN OUR TURF TO SECURE LONG TERM GROWTH
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Product Indication YTD (NT$mn) YoY (%) Remarks
1 Goserelin (Zoladex) Breast cancer 乳癌 523.9 +361%Exclusive marketing alliance with
AstraZeneca KR; launched Oct’16
2 Sarpogrelate Anticoagulant 抗凝血 400.7 +8% Dosage improved to 1/day
3 Calcium Polystyrene Sulfonate Nephrology 腎臟病 360.2 +2%
4 Rosuvastatin/EzetimibeCardiovascular降血脂與膽固醇
317.8 +54% FDC; launched in 1Q16
5 Seroquel (Quetiapine) Schizophrenia 精神分裂症 300.6 -13%Exclusive marketing alliance with
AstraZeneca KR; launched Oct’15
6 Phentermine
Anti-obesity 減肥Oral contraceptive
口服避孕藥262.1 -16%
7 Desogestrel/EE (Mercilon)Oral contraceptive
口服避孕藥250.0 +23%
Acquired from Bayer; launched in
May’16
8 Bicalutamide Prostate cancer 攝護腺癌 222.0 +145%Exclusive marketing alliance with
AstraZeneca KR; launched Oct’16
9 Phendimentrazine Anti-obesity 抑制食慾 184.3 -20%
10 Anastrozole (Arimidex) Oncology 癌症 182.8 +363%Exclusive marketing alliance with
AstraZeneca KR; launched 4Q’16
11 Zoledronic Acid (Aclasta) Osteoporosis 骨質疏鬆症 154.6 -Acquired from Novartis; launched
Apr’17; TW product
12 Orlistat Anti-obesity 減肥 148.9 -33%
13 Ibandronate D3 Osteoporosis 骨質疏鬆症 80.4 -22%
14 Diltiazem Cardiovascular 降血壓 78.2 -1%
15 Recombinant Human
Erythropoietin
Nephro + Onco
腎臟與癌症用紅血球生成素52.1 -18%
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WE ARE ALSO MAKING GREAT PROGRESS IN INNOVATION
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2017 R&D Projects for
Export Markets
LATE PHASE
Vinorelbine softgel capsules for Europe
LP149 for Europe and US
SUBMISSIONS
Methotrexate for US
Gefitinib for Europe
Lenalidomide for US, Europe and APAC
LAUNCHES Temozolomide for US, Europe and APAC
Levetiracetam ER & IR for US
Calcium Acetate for US
LAUNCH PREPERATIONSLevonorgestrel for US
Paricalcitol softgel capsules for US
6 submissions for US and Europe markets in 2017
10+ # total active R&D projects
~85% % of R&D projects launching between 2018 – 2021
Norethisterone／Ethinylestradiol LD for JP
TS-1 for KR
Acarbose for China
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Generic Name Indication Country Approval Date Remarks
1 Aclasta 5mg/100ml Solution for infusion Osteoporosis骨質疏鬆
TW Jan’17 Acquired
2Rosuvastatin/Candesartan 5mg/8mg,
10mg/8mg, 10mg/16mg, 20mg/32mgCVS
心血管疾病KR May’17 Own development
3 Bortezomib (vial) 3.5mg, 1mg Mantle Cell Lymphoma
多發性骨隨瘤KR May’17 In license
4 Native black cohosh extractHerbal Medicine for Women Health更年期常見症狀
TW June’17 In license
5 Pregabalin 75mg, 150mgCNS帶狀泡疹後神經痛、局部癲癇
KR July’17 Own development
6Norethisterone/ Ethinylestradiol
1mg/0.035mg Contraceptive避孕
JP Aug’17 CDMO
7
Drospirenone/ Ethinyl Drospirenone/
Ethinyl Estradiol
3mg/0.02mg Film-Coated Tablets
Contraceptive避孕
TW Aug’17 In license
8 TS-1 20mg, 25mg Oncology癌症
KR Aug’17 Own development
9 Raloxifene/cholecalciferol Osteoporosis骨質疏鬆
KR Sept’17 Own development
10 Lenalidomide 25mg (Lenli capsule) Multiple Myeloma血癌
TW Nov’17 Own development
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MA list 2017
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Generic Name Indication
IMS
Market Size
(US$mn)
Formulation BE & CT Submission Approval
1 AK-R214 (SR)Smoking Cessation
戒菸37
2 AK-R215 (FDC)Osteoporosis
骨質疏鬆18
3 AK-R308 Osteoporosis
骨質疏鬆8
4 AK-R310Flu
流感33
HIGH VALUE PIPELINE BASED ON STRONG R&D CAPABILITIES
Continuous IMD pipeline for Korea
To be launched in 2017 - 2019
• Korea IMD (“Incrementally Modified Drug”) path is similar to US 505(b)2, which requires phase I and phase III study while enjoying
premium on NHI price; it usually takes 6 to 12 months to go through regulatory approval
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CDMO projects for Japan
Generic Name Indication
IMS
market size
(US$mn)
Formulation BE & CT Submission Approval
1 LP083 ULDWomen health
女性保健100
2 Gefitinib
Non-small-cell lung
cancer
非小細胞肺癌130
To be launched in 2017 - 2019
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Generic Name Indication IMS
market size
(US$mn)
CTP1
submission BE & CT
IDL2
submission Approval
1 LevonorgestrelContraception
避孕13
2 Divalproex sodium Anti-epilepsy
抗癲癇100
3 LidocaineLocal analgesic
局部麻醉50
4 AcarboseAntidiabetic
糖尿病400
5 LevetiracetamAnti-epilepsy
抗癲癇45
6 TemozolomideBrain cancer
腦癌100
7 MemantineAnti-dementia
老人癡呆18
Aggressive product filing in China
To be launched in 2017 - 2020
• All the filings in China are approved products in Taiwan
• For imported drugs, there are two applications needed – Clinical Trial Permit (“CTP”) submission goes first and then Imported Drug
License (“IDL”) submission is required once clinical/BE study is completed
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Generic Name Indication
IMS
market size
(US$mn)
Formulation BE & CT Submission Approval
1Budesonide
ERGI 結腸潰瘍 US: 200
2Buprenorphine/
Naloxone
Addiction
戒毒US: 2,000
3 MethotrexateChemo
癌症US: 340
4 Gefitinib
Non-small-cell
lung cancer;
Inhibitor
非小細胞肺癌
Global: 375
5 LenalidomideMultiple
Myeloma
血癌
Global:
2,100
6 VinorelbineBreast cancer;
Chemo
乳癌EU: 130
7 LP149Women health;
女性保健Global: 110
8 LP650GIST; inhibitor腸胃道間質腫瘤
EU & APAC:
440
READY TO ENJOY OPPORTUNITIES IN US & EU WITH HIGH VALUE PIPELINE
One of the very few non-Indian pharmaceuticals with growing export pipeline
To be launched in 2018 - 2021
NO BE
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PIV; non-infringement
PIV; trial completed
FTF approach
NO BE
PIV; sued in US; first response
CRL