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Lotus Pharm — Investor Presentation 2017
Aug 31, 2017
51923_rns_2017-08-31_92ffb0f0-568b-4b38-8c56-df1df7f519dd.pdf
Investor Presentation
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LOTUS PHARMACEUTICAL BUILDING A REGIONAL LEADER
Aug 2017
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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
Company Overview
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Profitable Growth
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1H 2017 Financial Results
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COMPANY OVERVIEW
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LOTUS PHARMACEUTICAL IS AN APAC GENERICS LEADER
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Founded in 1966
Lotus 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
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
The rising generic leader in APAC
Lotus 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
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A FAST GROWING GENERICS & SPECIALTY PHARMACEUTICAL POWERHOUSE
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Lotus facts
1000+ Employees
3 Manufacturing and R&D Centers
250+ Marketed products
140+ Submissions since 2012
Lotus Taiwan Employees Total: 365
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11%
G&A
19% R&D
47%
S&M
Plant
23%
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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
Alvogen Korea Employees
Total: 561
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9%
7%
32%
52%
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G&A R&D S&M Plant
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THE PAST 2 YEARS WERE TRANSITIONAL
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Operating synergy emerging following transitions in portfolio and S&M strategies
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OPEX % 69% 50% 52% 39% 52% 50% 50% 49% 44% 46% 51% 66% 42% 37%
Total OPEX
(NT$mn) 1,590 2,780 3,084 1,172 675 669 711 725 631 742 729 982 592 580
SM GA RD OPM
6%
15.7%
4%
4% 7% 6%
20% 7% 4% 8.9%
12% 4%
5% 8% 12% 10% 6%
12% 10% 14% 16% 4%
10%
12%
12% 5% 10%
41.7%
10% 36% 34% 34%
30% 30% 28% 29% 26%
22%
43%
11.4% 10.4% [12.9%] 10.6%
33% 32% 6.8% 8.5%
5.4% 5.6% 5.6%
24%
Q1'15 Q2'15 Q3'15 Q4'15 Q1'16 Q2'16 Q3'16 Q4'16 Q1'17 Q2'17
-13.0%
FY2014 FY2015 FY2016 1H2017
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EXPANDING REVENUE AND GROSS MARGIN ARE OUR TOP PRIORITIES
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Revenue (NT$m) Gross margin
| 663 1294 1337 1417 1473 1425 1594 1404 1479 1436 1557 Q4'14 Q1'15 Q2'15 Q3'15 Q4'15 Q1'16 Q2'16 Q3'16 Q4'16 Q1'17 Q2'17 |
43% 58% 57% 62% 58% 55% 59% 57% 54% 47% 47% |
|---|---|
| Q4'14Q1'15Q2'15Q3'15Q4'15Q1'16Q2'16Q3'16Q4'16Q1'17Q2'17 |
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AFTER 2.5 YEARS OF INTEGRATION, LOTUS IS ENTERING INTO A GROWTH PHASE
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2015-2016 2017-2018 2019
POST MERGER INITIAL EXPLOSIVE
INTEGRATION GROWTH GROWTH
PHASE PHASE PHASE
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Plant upgrade in Nantou, Taiwan
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Successful management team change
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Portfolio and pipeline reshape
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Sales and marketing strategy adjustment
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Solidify local portfolio through key launches
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Start shipments of ANDA approved drugs
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Continue to increase operational efficiency
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Export revenues to significantly grow from several successful key PIVchallenges
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High value products to drive up gross margin
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• Continue to improve financial structure
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PROFITABLE GROWTH
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OUR GOAL IN THE NEXT 3 YEARS IS TO DELIVER PROFITABLE GROWTH
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Profitable Growth
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Back to Basics
Value Differentiation Geared Up For The Future
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BACK TO BASICS
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Strongest Portfolio
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Best Service
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Best Quality
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STRONGEST PORTFOLIO SURROUNDING 5 SPECIALTY AREAS
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2016E to 2020F therapeutic area revenue breakdown
2016A
1H2017
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2020F
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19% 28% 33% 41% 39% 18% 22% 6% 8% 5% 16% 16% 2% 3% 4%
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17%
17%
6%
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Anti-obesity/lifestyle & Gastrointestinal products Cardiovascular Central Nervous System Oncology Women healthcare
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Note: Others include respiratory system, pain killers, nephrology, anti-inflammatory and so on
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STRONGEST LOCAL PORTFOLIO WITH MARKET SHARE LEADER POSITION
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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 |
| Market Position |
• Focuses on Incrementally Modified Drug such as Fixed Dosage Combination • 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 |
• Top 3 pharma company in Taiwan on consolidated revenue base • Leading player in CNS, oncology and hormonal drugs |
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LOTUS PHARMACEUTICAL PROVIDES BEST SERVICE IN EVERY ASPECT
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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
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
The best R&D partner
Partner with new drug companies from formulation development, phase I, or clinical trial, providing critical CDMO or R&D services to new oncology drugs companies targeting advanced markets such as US, EU and JP
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BEST QUALITY MAKES US THE MOST PREFERRED PARTNER OF OUR CUSTOMERS
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Lotus quality record
| 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 |
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VALUE DIFFERENTIATION
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Shortest Time to Market
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High Value Pipeline
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• Leader in Special Dosage
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LEVERAGE ALVOGEN‘S GLOBAL SALES NETWORK TO CROSS SELL
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Capture global generics growth through Alvogen’s 3 regional platforms
IMS “Global Spending On Medicines 2014-2020”
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30% 37%
7%
Europe 46%
Asia
49% $25-35bn growth
North America $100-130bn growth
44%
$115-145bn growth
15%
AFME 26%
$15-25bn growth
59%
30% 33%
9%
50%
Latin America 30%
$25-35bn growth
13%
61%
35%
52% Global
$305-335bn growth
Brand Generic Other
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THEREFORE, LOTUS CAN ACHIEVE SHORTEST TIME TO MARKET
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Ability to leverage customer demand information across the group
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Robust regional supply chain network
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✓ Prompt and seamless coordination of complex supply and distribution network
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✓ Supported by 5 manufacturing sites across the Lotus and Alvogen group
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Ability to deliver 97% order next-day without major stock-outs
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HIGH VALUE PIPELINE FUELS REVENUE AND PROFITABILITY GROWTH
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Export timeline from now – 2020 approval out-license shipment
| INN | Indication | 1H’16 | 2H’16 | 1H’17 | 2H’17 | 2018 | 2019 | 2020 |
|---|---|---|---|---|---|---|---|---|
| Paricalcitol 1/2/4 mcg |
Nephrology 慢性腎衰竭 |
|||||||
| Temozolomide 5/20/100/140/180/ 250 mg |
Brain Cancer 腦癌 |
|||||||
| Levetiracetam ER 500/750mg IR 250/750/1000mg |
Anti-epilepsy 抗癲癇 |
|||||||
| Levonorgestrel 0.75mg |
Contraceptive 避孕 |
|||||||
| Calcium Acetate 667mg |
Nephrology 洗腎 |
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| Budesonide ER | GI 結腸潰瘍 |
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| Buprenorphine/ Naloxone |
Addiction 戒毒 |
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Export timeline from now – 2020 approval out-license shipment
| INN | Indication | 1H’16 | 2H’16 | 1H’17 | 2H’17 | 2018 | 2019 | 2020 |
|---|---|---|---|---|---|---|---|---|
| Methotrexate | Chemo 癌症 |
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| Gefitinib | Non-small-cell lung cancer; Inhibitor 非小細胞肺癌 |
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| LP127 | Anti-epilepsy 抗癲癇 |
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| LP083 (CDMO project / JP) |
Women health 女性保健 |
Strengt | ||||||
| h extension | ||||||||
| Acarbose | Antidiabetic 糖尿病 |
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| Vinorelbine softgel capsule |
Breast cancer 乳癌 |
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| Lenalidomide | Multiple Myeloma 血癌 |
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| LP149 | Women health 女性保健 |
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LOTUS PHARMACEUTICAL IS THE REGIONAL LEADER IN SPECIAL DOSAGE
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Soft Gel Manufacturing
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Investment in dedicated manufacturing area starting 2009 and current capacity at 500mn capsules / year
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State of the Art equipment
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✓ Closed melting and mixing Tanks
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✓ PharmaGel GKF-072 filling machine
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✓ Fully automatic visual inspection
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Extensive soft gel manufacturing experience in
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✓ BCS class III & class IV new drug
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✓ Generics low melting point molecules
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✓ Generics with low stability molecules that are sensitive to light, heat and humidity
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GEARED UP FOR THE FUTURE
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Biosimilar Ready
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M&A Mode Always On
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Winning Business Strategies
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BIOSIMILAR READY
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Lotus’ Biosimilar Play
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Biosimilars have reached an inflection point and we expect very rapid growth from 2017 onwards
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Secured APAC ex. Japan distribution rights of 2 biosimilar products of Alvotech, Alvogen’s sister company
US$Bn
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20.0
1.9
18.0 1.7
1.5
16.0
1.2
4.8
4.9
1.0
14.0 4.2
3.8
0.8 3.4
12.0
2.8
10.0
0.6
8.0
2.2
6.0 12.1 12.5 12.7
0.4 10.6 11.1
1.5 9.1
4.0
6.5
0.2
2.0 1.1 3.7
0.2
0.1 0.9
- 0.1 0.4 0.1 0.1 0.5 0.1 0.1 0.6 0.2 0.7 0.3 0.6 1.5
2012 2013 2014 2015 2016F 2017F 2018F 2019F 2020F 2021F 2022F 2023F 2024F 2025F
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Source : PharmaCloud US Europe ROW
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M&A MODE ALWAYS ON
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Constantly looking for companies that complements our S&M strategy or portfolio
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5yr CAGR (%) Pharmaceutical Market Size (US$bn)
2.1% Japan 107.0
9.9% China 98.8
11.6% India 16.7
3.7% Korea 15.8
9.2% Indonesia 5.9
7.1% Taiwan 5.5
7.3% Thailand 4.5
5.2% Philippines 3.8
13.9% Vietnam 3.3
11.5%
Malaysia 2.2
9.2%
Bangladesh 2.0
8.0% Hong Kong 1.6
7.6% Singapore 0.8
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AS THE EXPERT IN ASIA, LOTUS HAS A SET OF WINNING BUSINESS STRATEGIES
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Being the expert in APAC pharmaceutical market
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We address APAC market through both local sales team and distribution network
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We fulfill the neglected generic needs of key local markets to bring down healthcare cost for more people
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We out-license or divest certain portfolio that are better fits of other pharmaceuticals to extract full value of our assets
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1H 2017 FINANCIAL RESULTS
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HIGHER OPERATIONAL EFFICIENCY LED TO A PROFITABLE QUARTER
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| Unit: NT$000 | 2Q 2017 | % | 2Q 2016 | % | 1Q 2017 | % | YoY | QoQ | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| REVENUE | $1,577,430 | 100 | $1,594,332 | 100 | $1,436,112 | 100 | -1.1% | 9.8% | ||||
| COGS | 829,640 | 53 | 647,382 | 41 | 763,716 | 53 | 28.2% | 8.6% | ||||
| GROSS PROFIT | 747,790 | 47 | 946,950 | 59 | 672,396 | 47 | -21.0% | 11.2% | ||||
| OPEX | ||||||||||||
| S&M | 350,393 | 22 | 450,149 | 28 | 366,801 | 26 | -22.2% | -4.5% | ||||
| G&A | 160,021 | 10 | 225,584 | 14 | 146,902 | 10 | -29.1% | 8.9% | ||||
| R&D | 69,653 | 4 | 66,093 | 4 | 78,262 | 6 | 5.4% | -11.0% | ||||
| Total OPEX | 580,067 | 37 | 741,826 | 47 | 591,965 | 42 | -21.8% | -2.0% | ||||
| OPERATING PROFIT (LOSS) | 167,723 | 11 | 205,124 | 13 | 80,431 | 5 | -18.2% | 108.5% | ||||
| NON-OP INCOME & EXP | ||||||||||||
| Finance costs | (63,341) | (4) | (71,021) | (4) | (61,139) | (4) | -10.8% | 3.6% | ||||
| Others | 1,774 | 0 | (12,481) | (1) | (87,189) | (6) | - | - | ||||
| Total non-op expenses, net | (61,567) | (4) | (83,502) | (5) | (148,328) | (10) | -26.3% | -58.5% | ||||
| INCOME BEFORE TAX | 106,156 | 7 | 121,622 | 8 | (67,897) | (5) | -12.7% | NA | ||||
| INCOME TAX EXPENSE (BENEFIT) |
48,632 | 3 | 67,267 | 4 | (5,806) | - | -27.7% | NA | ||||
| NET ERANINGS (LOSS) | 57,524 | 4 | 54,355 | 3 | (73,703) | (5) | 5.8% | NA | ||||
| EPS | $0.15 | $0.07 | $(0.30) | 114.3% | NA | |||||||
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BALANCE SHEET AT JUNE-30 2017
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