lotus · market size • population:50mn • pharmaceutical market: us$15.8bn @ 3.7% yoy growth...
TRANSCRIPT
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LOTUSBUILDING A PAN-REGIONAL LEADER
November 2016
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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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GENERICS BUSINESS REQUIRES…
• Less haste, more speed and agility
• Broad portfolio
• Geographical expansion
• Low cost manufacturing and
economies of scale
• Strong cash flow
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OUR PILLARS
We don’t have to be perfect, just the best in our industry.
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Best PeopleSuccessful integration of local experts and Alvogen
Industry leading footprints
Best Portfolio Focus on niche specialty generics
No single drug contributes > 5% of total revenues
Strong track record of building business scale through product acquisitions
Best Quality
US, EU, JP, TW & KR approved manufacturing facilities
with outstanding history of quality
Best Service Strong stock management and customer relationships
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2
3
4
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BEST PEOPLE
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SHAREHOLDING STRUCTURE
Alvogen Emerging
Markets Holdings Ltd.
(Hong Kong)
63.4%
Lotus Pharmaceutical Co.,
Ltd.
(Taiwan)
Alvogen Taiwan
(Taiwan)
100.0% 100.0%
Alvogen Korea Holdings
Ltd.
(Korea)
Alvogen Korea Co., Ltd.
(Korea)
82.5% 100.0%
98.0%
Alvogen Pharma India Pvt
Ltd.
(India)
Norwich Clinical Services
Pvt Ltd.
(India)
100.0%
100.0%
樂特仕生物科技諮詢
(上海)有限公司
(China)
Lotus International Pte.
Ltd.
(Singapore)
Merger between Kunwha and
Dream Pharma has been
completed on June 1, 2015 Page I 6
Alvogen Lux Holding Sarl
(Luxembourg)
CVC Capital
Partners
Temasek Holdings
Robert Wessman &
Founding Team
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ALVOGEN’S
3 MAJOR REGIONAL
PLATFORMSUSANew Jersey
EUROPERomania
ASIATaiwan
S-Korea
CROBangalore
Albania Bulgaria Bosnia
China Croatia Estonia
Hong Kong Hungary
Iceland Ireland India
Kazakhstan Kosovo
Latvia Lithuania
Macedonia Moldova
Montenegro Myanmar
Netherlands Poland
Romania Russia Serbia
Singapore South Korea
Thailand Taiwan Ukraine
USA UK Vietnam
32 COUNTRIES
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USA
54%CEE
18%APAC
28%
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1966
Manufacturing Facility Approved by Japan PMDA
Lotus Acquired Dream Pharma
Founded in 1966
Manufacturing Facility Approved by US FDA
First Product Launched in the US
Manufacturing Facility Approved by EU EMA
First Product Launched in Japan
Passed US FDA Compliance Inspection
Alvogen Became a Majority Shareholder of Lotus
Lotus Acquired Alvogen’s Korea, Taiwan and India Businesses
Aug 11
Dec 19
Passed EU EMA Compliance Inspection
Listed in GreTai
Stock Exchange
(1795.TT)
Jun 1
Kunwha and Dream Pharma,
Merged into Alvogen Korea
LOTUS’ JOURNEY
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OUR MANAGEMENT TEAM
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John doherty
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LOTUS SNAPSHOT
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KOREA TAIWAN
Market Size • Population: 50mn
• Pharmaceutical market: US$15.8bn @ 3.7%
YoY growth
• Population: 23mn
• Pharmaceutical market: US$5.5bn @ 7.1%
YoY growth
CoreBusiness
Description
• Alvogen acquired KunWha in 2012 and
KunWha acquired Dream Pharma in 2014
• KunWha & Dream Pharma merged and
became Alvogen Korea in 2015
• Alvogen Korea focuses on Incrementally
Modified Drug such as Fixed Dosage
Combination
• Founded in 1966 and went IPO in 2010
• Top 3 pharma company in Taiwan on
consolidated revenue base
• Early mover to start export to regulated
markets (US, EU, JP)
MarketPosition
• Anti-obesity drugs market share leader (20%)
in Korea
• OTC contraceptive drug market share leader
(40%) in Korea
• Leading player in CVS, CNS and nephrology
drugs in Korea
• Expanding into oncology and women health
markets
• Leading player in CNS, oncology and hormonal
drugs
• Board portfolio including also pain, CVS and
other general care products
R&D • Leading R&D personnel: 74% with post
graduate degree, 49% with industry
experience > 10 years
• Won Korea’s New Drug Development
Technical Award for Bonviva Plus (Dream
Pharma in Feb, 2014)
• The R&D center with a special focus on
developing drugs for US, JP and APAC
markets
• Leading R&D personnel: 65% with post
graduate degree and extensive industry
experiences
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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;
8 MAs in Japan; 1 MA in China
LOTUS BY NUMBERS
A Fast Growing Generic and Specialty pharma
Company with
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1000+ Employees
3 Manufacturing and R&D Centers
250+ Marketed products
140+ Submissions since 2012
14%
21%
23%
42%
Lotus Taiwan EmployeesTotal: 328
G&A
R&D
S&M
Plant
12%
7%
46%
35%
Alvogen Korea EmployeesTotal: 573
G&A
R&D
S&M
Plant
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MORE TO COME
Organic Growth and Strategic M&A
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1Double digit CAGR from 2016 to 2020 from existing products gaining market
share and strong growth potential from our pipeline in new markets
2Create consolidation synergy ahead of industry through Alvogen’s global M&A
strategy as we are constantly looking for complementary targets in APAC
0
100
200
300
400
2016E 2017E 2018E 2019E 2020E
2020 Launch
2019 Launch
2018 Launch
2017 Launch
2016 Launch
Existing
US$M
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BEST PORTFOLIO
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MARKET DYNAMICS
Global Spending On Medicines 2014 - 2020
Generics continue to drive growth globally while US continues to be the key market
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North America
$115-145bn growth
Latin America
$25-35bn growth
Europe
$25-35bn growthAsia
$100-130bn growth
AFME
$15-25bn growth
Source: IMS
49%
44%
7%
9%
61%
30%
33%
50%
30%
37%
46%
30%
26%
59%
15%
35%
52%
13%
Brand Generic Other
Global
$305-335bn growth
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MARKET DYNAMICS
Well-positioned in Highly Attractive and Fast Growth Markets in Asia…
Pharma Market Size
(US$bn)
5yr CAGR
(%)
2.1%
9.9%
11.6%
3.7%
9.2%
7.1%
7.3%
5.2%
13.9%
11.5%
9.2%
8.0%
7.6%
Source: BMI Research
0.8
1.6
2.0
2.2
3.3
3.8
4.5
5.5
5.9
15.8
16.7
98.8
107.0
Singapore
Hong Kong
Bangladesh
Malaysia
Vietnam
Philippines
Thailand
Taiwan
Indonesia
Korea
India
China
Japan
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Well-planned to access Japan and China
markets
• 4 products/CMO projects for Japan in
pipeline
• 7 products filed in China
Leveraging existing production capabilities
and commercial network through Alvogen’s
platforms to further penetrate into fast
growing markets in South East Asia
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BALANCED AND SPECIALIZED PORTFOLIO
5 key therapeutic area with a keen focus on difficult-to-make generics
• Oncology
• Cardiovascular (CVS)
• Central Nerve System (CNS)
• Women Health
• GI/Anti-obesity
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29%
20%
9%2%
4%
36%
Consolidated Revenues YTD by Therapeutic Area
Anti-obesity & GICardiovascularCentral Nervous SystemOncologyWomen healthcareOthers
Note: Others include respiratory system,
pain killers, nephrology, anti-inflammatory
and so on
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CLOSE UP ON THERAPEUTIC AREA BY REGION - FORECAST
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46%
9%7%
9%
29%
2016
41%
12%14%
9%
24%
2018
35%
12%23%
8%
22%
2020
CNS
CVS
Oncology
Women Health
Others
TAIWAN• Continue to focus on CNS cash cow products
• To grow oncology business and hospital customers
29%
20%9%
13%
29%
2016
22%
17%
7%
14%
40%
2018
21%
18%
8%14%
39%
2020Anti-obesity & GI
CVS
Nephrology
NS/Anti-inflammatoryOthers
KOREA• Continue to focus on anti-obesity and CVS cash cow products
• Leverage Lotus R&D capabilities to tap into oncology and women health markets (others)
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Generic Name Indication Country Approval Date Remarks
1 Diosmin 500mg Metabolism
靜脈疾病TW Jan’16 In license
2 Olanzapine 5mg, 10mgSchizophrenia
精神分裂症TW Jan’16 In license
3 Paricalcitol 1mcg, 2mcg, 4mcg Nephrology
慢性腎臟病US Feb’16 Own development
4Temozolomide Capsles 5mg, 20mg,
100mg, 140mg, 180mg, 250mg
Brain cancer
腦癌US Apr’16 Own development;
5 Acyclovir Lyophilized 250 mgHerpes simplex infection單純皰疹感染
TW Apr’16 In license
6 Capecitabine 150mgCancer
癌症KR May’16 In license
7 Desogestrel/EE Tablet 0.15mg/0.02mgOral contraception
避孕KR May’16 Acquired
8 Levetiracetam ER Tablets CNS
抗癲癇US Jun’16 Own development
9 Pantoprazole 40mg LyophilizedGI腸胃道疾病
TW June’16 In license
10 Solifenacin Tablet 10mg, 5mgUrinary symptoms泌尿道疾病
KR June’16 Own development
‘16YTD PROGRESS
MA received 2016 YTD – Part 1
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Generic Name Indication Country Approval Date Remarks
11 Calcium Acetate Capsule 667mgNephrology
腎臟病US July’16 Own development
12 Phendimetrazine half strengthAnti-obesity
減肥KR July’16 Own development
13 Lamivudine Tablet 100mgHIV抗逆轉錄病毒
SEA Aug’16 CMO
14Temozolomide Capsules
20 mg &100 mg
Brain cancer
腦癌SEA Aug’16 Own development
15 Levonorgestrel Tablets 0.75 mgContraceptive避孕
US Sept’16 Own development
16 Remifentanil 2mgAnesthesia麻醉
TW Sept’16 Own development
17Telmisartan/Amlodipine Besylate
Tablet 5mg
CVS心血管疾病
KR Sept’16 Own development
‘16YTD PROGRESS
MA received 2016 YTD – Part 2
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PRODUCTS & PIPELINE UPDATES
Top 15 Products YTD
Product IndicationYTD $
(NT$mn)YoY (%) Remarks
1 Sarpogrelate Anticoagulant 抗凝血 310.6 +257% Dosage improved to 1/day
2 Calcium Polystyrene Sulfonate Nephrology 腎臟病 267.1 +7%
3 Seroquel (Quetiapine) Schizophrenia 精神分裂症 258.2 -
Exclusive marketing alliance
with AstraZeneca Korea;
launched in Oct’15
4 Phentermine Anti-obesity 減肥 253.8 -7%
5 Phendimetrazine Anti-obesity 抑制食慾 187.8 -9%
6 Orlistat Anti-obesity 減肥 187.3 -16%
7 Rosuvastatin/EzetimibeCardiovascular降血脂與膽固醇
148.3 - FDC; launched in 1Q16
8 Desogestrel/EEOral contraceptive
口服避孕藥135.1 -
Acquired from Bayer
Mercilon; launched in May’16
9 Topiramate CNS 抗癲癇 91.6 -11%
10Recombinant human
erythropoietin
Nephrology & Cancer腎臟病與癌症患者用紅血球生成素
68.4 -32%
11Ephedrine/Acetaminophen/
Caffeine
Pain killer止痛
67.3 -1%
12 Ibandronate-Vitamin D3 Osteoporosis 骨質疏鬆症 66.0 +284%
13 Rosuvastatin Calcium Cardiovascular 降血脂 61.7 -28%
14 Diltiazem Cardiovascular 降血壓 58.9 +24%
15 MethylprednisoloneCorticosteroid
減緩發炎的皮質類固醇56.0 +3%
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Generic Name Indication IMS 2015
market size (US$mn)Formulation BE & CT Submission Approval
1Not Disclosed CNS
抗癲癇US: 700
2 Budesonide ER GI 結腸潰瘍 US: 140
3Buprenorphine/
Naloxone
Addiction
戒毒US: 2,000
4 Not DisclosedCancer
血癌US: 1,000
5 Not DisclosedCancer
癌症US: 300
6 Gefitnib
Non-small-cell
lung cancer
非小細胞肺癌EU: 350
7 VinorelbineBreast cancer
乳癌EU: 130
PRODUCTS & PIPELINE UPDATES
Strong And Broad Pipeline Targeting US & EU markets
To be launched in 2016 - 2019
NO BE
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Generic Name Indication
IMS 2015
Market Size
(US$mn)
Formulation BE & CT Submission Approval
1Rosuvastatin/ Candesartan
(FDC)
Cardiovasular
降血壓、降血脂146
2DP-R213
(FDC)
Osteoporosis
骨質疏鬆20
3Rosuvastatin/ Amlodipine
(FDC)
Cardiovascular
降血壓、降血脂235
4Rosuvastatin/ Candesartan
(FDC)
Cardiovascular
降血壓、降血脂146
5 AK-R214 (SR)Smoking Cessation
戒菸20
6 AK-R215 (FDC)Osteoporosis
骨質疏鬆4.5
7 AK-R308 Osteoporosis
骨質疏鬆4.5
PRODUCTS & PIPELINE UPDATES
Continuous IMD Pipeline Expansion For Korea Market
To be launched in 2016 - 2018
• Korea IMD (“Incrementally Modified Drug”) procedure is similar to US 505(b)2, which requires phase I and phase III study while
enjoying premium on NHI price; it usually takes 6 to 12 months for regulatory approval
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PRODUCTS & PIPELINE UPDATES
Generic Name Indication
IMS 2015
Market Size
(US$mn)
Formulation BE & CT Submission Approval
1 Not DisclosedAllergy
抗組織胺340
2 Not DisclosedContraceptive
避孕藥100
3 GefitinibNon-small-cell lung cancer
非小細胞肺癌130
4 CapecitabineCancer
癌症100
For Japan market
• For Japan market, we strategically work on CDMO projects for partners to further penetrate into the local market
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PRODUCTS & PIPELINE UPDATES
Generic Name Indication
IMS 2015
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
For China market
• All the filings in China are the approved products in Taiwan, so no duplicate formulation is required
• For all the imported products, 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 done
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BEST QUALITY
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LOTUS PLANTS
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KOREA – Gongju Plant Korea – Hyangnam Plant Taiwan – Nantou Plant
Products
• Tablets
• Coated tablets
• Hard capsules
• Powders, granules
• 21 molecules
• Tablets
• Coated tablets
• Hard capsules
• Powders, granules
• 63 molecules
• Tablets
• Coated tablets
• Softgel capsules
• Hard capsules
• 48 molecules
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
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THE LEADER IN SPECIAL DOSAGE
Soft Gel Manufacturing
• Investment in dedicated manufacturing area starting 2009
• State of the Art equipment
Closed melting and mixing Tanks
PharmaGel GKF-072 filling machine
Fully automatic visual inspection
• Extensive soft gel manufacturing experience for
BCS class III & class IV new drug
Generics low melting point molecules
Generics with low stability molecules that are sensitive to
light, heat and humidity
• Capacity: 500mn capsules every year
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BEST SERVICE
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SALES & MARKETING CENTRIC
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TAIWAN
• 70 in-house sales
• 3 sales offices nation-wide
• C. 3,400 clinics and c. 480 general hospitals in Taiwan
Head office in Taipei
Plant in Nantou
Sales office
in Taipei
Sales office
in Taichung
Sales office
in Kaohsiung
Plant in Hyangnam
Head office in Seoul
Plant in Kongju
KOREA
• 299 in-house sales
• 12 sales offices nation-wide: 4 in Seoul and satellite
cities and 8 in other areas
• Account coverage: C. 6000 clinics and c. 670 general
and community hospitals in Korea
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VERTICAL INTEGRATION- CRO CAPABILITIES IN INDIA
Bangalore
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INDIA – NORWICH CLINICAL SERVICES
• Provides Biostudy, Clinical and pharmacovigilance services to Lotus &
Alvogen Group and 3rd party customers
• Located within a multi-specialty hospital
• Clinical Area: 17,000 sq.ft with 72 bed facility
Set-up: medical and surgical IC units, emergency unit, oncology
center, well-equipped lab and pharmacy
• Office/Lab area: 30,000 sq. ft
Set-up: corporate offices, pharmacovigilance, bio-analytical studies,
PK/Biostats/medical writing, clinical data management, QA
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R&D SERVICES
The Best Partner
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• Partnering with new drug companies from formulation development and phase I,
focusing on new oncology drug for advanced markets such as US, EU and JP
• Assist new drug companies in formulation improvement and clinical trial as a their
critical CDMO partner
• Provide special dosage development service to hospitals and medical schools
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FINANCIAL PERFORMANCE
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FINANCIAL HIGHLIGHTS
Robust Growth Momentum
Unit: NT$mn
More than doubled from Q4’14 to Q3’16
+9%
663
12941337
14171473
1425
1594
1404
Q4'14 Q1'15 Q2'15 Q3'15 Q4'15 Q1'16 Q2'16 Q3'16
4049
4423
Jan - Sept'15
Jan - Sept'16
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FINANCIAL HIGHLIGHTS
Improving Profitability
Unit: %
Gross Magin Operating Margin
• Improved significantly from 43.4% as of Q4’14 to
over 55% throughout 2015 and maintained at high
level
Unit: %
• Operating margin hit new high in Q2’16
-48.0%
5.4%6.8%
11.4%8.5%
10.4%12.9%
5.6%
Q4'14 Q1'15 Q2'15 Q3'15 Q4'15 Q1'16 Q2'16 Q3'1643%
58% 57%
62%
58%
55%
59%57%
Q4'14 Q1'15 Q2'15 Q3'15 Q4'15 Q1'16 Q2'16 Q3'16
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36%34% 34%
30% 30%28% 29%
12%12%
10%
12%10% 14%
16%
4%4% 7%
7%
4%4%
6%
Q1'15 Q2'15 Q3'15 Q4'15 Q1'16 Q2'16 Q3'16
FINANCIAL HIGHLIGHTS
OPEX % as of Total Sales
Total
OPEX % 69% 50%
1,590 2,780Total
OPEX (in
NT$mn)
43%
33%
20%
12%
6%
5%
FY2014 FY2015
50% 50% 49%
669 711 725
44%
631
52%
675
Sales & Marketing General & Admin Research & Development
46%
742
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51%
729
Page I 38-0.69
0.43
0.87
1.46
1.76
1.07
1.571.62
Q4'14 Q1'15 Q2'15 Q3'15 Q4'15 Q1'16 Q2'16 Q3'16
FINANCIAL HIGHLIGHTS
EPS v.s. Cash EPS
EPS (NT$) Cash EPS (NT$)
• EPS = Net Income / # of Outstanding Shares • Cash EPS = Cash flows from operating activities / # of
Outstanding Shares
• Better indicator as it represents real cash earned from
daily operations
• More cash EPS also illustrates a better financial shape
for further expansion
Net cash generated from operating
activities in Q3’16 = NT$387 million
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-1.08
-0.13
0.37
0.060.12
0.27
0.07
-0.14
Q4'14 Q1'15 Q2'15 Q3'15 Q4'15 Q1'16 Q2'16 Q3'16
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FINANCIAL HIGHLIGHTS
Results of Q3’16 – Income Statement
Unit: NT$mn unless otherwise stated
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FINANCIAL HIGHLIGHTS
Results of Q3’16 – Balance Sheet
Unit: NT$mn
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FINANCIAL HIGHLIGHTS
Results of Q3’16 – Cash Flow Statement
Unit: NT$mn
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2016 2015 Change
Income before income tax 258 244 14
Total non-cash adjustments 600 531 70
Net change in operating assets and liabilities 296 94 202
Interest and taxes received (paid) (139) (266) 127
CASH FLOWS FROM OPERATING ACTIVITIES 1,015 603 412
CASH FLOWS FROM INVESTING ACTIVITIES (386) (73) (313)
CASH FLOWS FROM FINANCING ACTIVITIES 2 (156) 158
EFFECTS OF EXCHANGE RATE CHANGES 6 (24) 30
NET INCREASE (DECREASE) IN CASH 637 350 287
CASH AT THE BEGINNING 1,578 1,096 483
CASH AT THE END 2,215 1,445 770
For the Nine Months
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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
LOW COST
TARGETED PORTFOLIO
ONLY THE BEST PEOPLE
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WE ARE STILL
CLIMBING AND
WE HAVE A
CLEAR VISION
FOR THE NEXT 5
YEARS