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Lotus Pharm — Management Reports 2018
May 15, 2018
51923_rns_2018-05-15_be6db590-b621-46f0-9ea6-0a56c875cdd2.pdf
Management Reports
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LOTUS PHARMACEUTICAL BUILDING 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
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
1
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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
300+ Marketed products
150+ Submissions since 2012
Lotus Taiwan Employees Total: 380
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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;
9 MAs in Japan; 1 MA in China
Alvogen Korea Employees
Total: 549
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9%
7%
32%
52%
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G&A R&D S&M Plant
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LOTUS SEES TANGIBLE PROGRESS TOWARD TRANSFORMATION
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~
2015-2016 2017-2018 2019
POST MERGER INITIAL EXPLOSIVE
INTEGRATION GROWTH GROWTH
PHASE PHASE PHASE
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Upgrade Nantou plant
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Change management team
-
Reshape Portfolio and pipeline
-
Adjust sales and marketing strategy
-
Resolve legacy issues
-
Solidify local portfolio through key launches
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Focus on specialty driven markets
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Continue to increase operational efficiency
-
Export revenues to significantly grow from several successful key PIVchallenges
-
High value products and economies of scale to drive up gross margin
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Strengthen balance sheet
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• Invest in key franchises and become category leader
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WE STABILIZED IN 2017 AND HAS LAID A SOLID GROWTH GROUND
4 Year Trend (NT$mn)
Rev. Gross Profit Operating Profit
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7000
6000
5000
4000
56%
59% 48%
3000
2000
50%
1000
8% 4% 8%
0
-19%
2014 2015 2016 2017
-1000
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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 | -$0.56 | NA |
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OPERATING REMARKS AND 2017 ACHIEVEMENTS HIGHLIGHTS
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2017 IS THE TIPPING POINT OF GEOGRAPHIC DIVERSIFICATION
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While Korea remains our backbone thanks to its market potential and favorable regulatory environment, Lotus successfully diversified its geographic exposure by growing Taiwan domestic and export market
2016FY 2017FY
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2.6% [4.0%]
8.0%
Korea
Taiwan
Export
India CRO
85.4%
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2.6%
6.5%
10.3%
80.6%
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YOY GROWTH LANSCAPE ACROSS MARKETS
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Export +173%
- Trazodone milestone fee from a Chinese
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-
partner
-
• Shipment of Temo, LVT and CAC to US
TW +40%
-
Successful launch of
-
Aclasta injection
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• 65% rev. growth from hospital channels thanks to new launches and oncology share gain
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KR +3%
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Eased anti-obesity competition in 2H17
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• Entry into oncology distribution market
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NEW PRODUCT LAUNCHES IN OUR TURF TO SECURE LONG TERM GROWTH
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| Product | Indication | YTD (NT$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/Ezetimibe | Cardiovascular 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% | Page I 16 Page I 16 |
WE ARE ALSO MAKING GREAT PROGRESS IN INNOVATION
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Norethisterone / Ethinylestradiol LD for JP TS-1 for KR
LAUNCHES
2017 R&D Projects for Export Markets LAUNCH PREPERATIONS
SUBMISSIONS
LATE PHASE
Temozolomide for US, Europe and APAC Levetiracetam ER & IR for US Calcium Acetate for US
Levonorgestrel for US
Paricalcitol softgel capsules for US
Methotrexate for US Gefitinib for Europe Lenalidomide for US, Europe and APAC Vinorelbine softgel capsules for Europe LP149 for Europe and US Acarbose for China
6 submissions for US and Europe markets in 2017 10+ # total active R&D projects
~85% % of R&D projects launching between 2018 – 2021
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MA list 2017
| Generic Name | Indication | Country | Approval Date | Remarks | |
|---|---|---|---|---|---|
| 1 | Aclasta 5mg/100ml Solution for infusion | Osteoporosis 骨質疏鬆 |
TW | Jan’17 | Acquired |
| 2 | Rosuvastatin/Candesartan 5mg/8mg, 10mg/8mg, 10mg/16mg, 20mg/32mg |
CVS 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 extract | Herbal Medicine for Women Health 更年期常見症狀 |
TW | June’17 | In license |
| 5 | Pregabalin 75mg, 150mg | CNS 帶狀泡疹後神經痛、局部 癲癇 |
KR | July’17 | Own development |
| 6 | Norethisterone/ 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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HIGH VALUE PIPELINE BASED ON STRONG R&D CAPABILITIES
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Continuous IMD pipeline for Korea
| To be launched in 2017 - 2019 | |||||||
| Generic Name | Indication | IMS Market Size (US$mn) |
Formulation | BE & CT | Submission | Approval | |
| 1 | AK-R214 (SR) | Smoking Cessation 戒菸 |
37 | ||||
| 2 | AK-R215 (FDC) | Osteoporosis 骨質疏鬆 |
18 | ||||
| 3 | AK-R308 | Osteoporosis 骨質疏鬆 |
8 | ||||
| 4 | AK-R310 | Flu 流感 |
33 | ||||
| • Korea IMD (“Incrementally Modified Drug”) path is similar to US 505(b)2, which requires phase I and phase III study while enjoying premium on NHI price; it usually takes 6 to 12 months to go through regulatory approval |
- Korea IMD (“Incrementally Modified Drug”) path is similar to US 505(b)2, which requires phase I and phase III study while enjoying premium on NHI price; it usually takes 6 to 12 months to go through regulatory approval
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CDMO projects for Japan
| To be launched in 2017 - 2019 | |||||||
| Generic Name | Indication | IMS market size (US$mn) |
Formulation | BE & CT | Submission | Approval | |
| 1 | LP083 ULD | Women health 女性保健 |
100 | ||||
| 2 | Gefitinib | Non-small-cell lung cancer 非小細胞肺癌 |
130 |
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Aggressive product filing in China
To be launched in 2017 - 2020
| To be launched in 2017 - 2020 | |||||||
| Generic Name | Indication | IMS market size (US$mn) |
CTP1 submission |
BE & CT | IDL2 submission |
Approval | |
| 1 2 3 4 5 6 7 |
Levonorgestrel | Contraception 避孕 |
13 | ||||
| Divalproex sodium | Anti-epilepsy 抗癲癇 |
100 | |||||
| Lidocaine | Local analgesic 局部麻醉 |
50 | |||||
| Acarbose | Antidiabetic 糖尿病 |
400 | |||||
| Levetiracetam | Anti-epilepsy 抗癲癇 |
45 | |||||
| Temozolomide | Brain cancer 腦癌 |
100 | |||||
| Memantine | Anti-dementia 老人癡呆 |
18 | |||||
| • All the filings in China are approved products in Taiwan • For imported drugs, there are two applications needed – Clinical Trial Permit (“CTP”) submission goes first and then Imported Drug License (“IDL”) submission is required once clinical/BE study is completed |
-
All the filings in China are approved products in Taiwan
-
For imported drugs, there are two applications needed – Clinical Trial Permit (“CTP”) submission goes first and then Imported Drug License (“IDL”) submission is required once clinical/BE study is completed
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READY TO ENJOY OPPORTUNITIES IN US & EU WITH HIGH VALUE PIPELINE
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One of the very few non-Indian pharmaceuticals with growing export pipeline
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To be launched in 2018 - 2021
IMS
Generic Name Indication market size Formulation BE & CT Submission Approval
(US$mn)
Budesonide
1 GI 結腸潰瘍 US: 200 PIV; non-infringement
ER
Buprenorphine/ Addiction
2 US: 2,000 PIV; trial completed
Naloxone 戒毒
Chemo
3 Methotrexate 癌症 US: 340 NO BE CRL
Non-small-cell
lung cancer;
4 Gefitinib Global: 375
Inhibitor
非小細胞肺癌
Multiple
Global:
5 Lenalidomide Myeloma PIV; sued in US; first response
2,100
血癌
Breast cancer;
6 Vinorelbine Chemo EU: 130
乳癌
Women health;
7 LP149 Global: 110 FTF approach
女性保健
GIST; inhibitor EU & APAC:
8 LP650 腸胃道間質腫瘤 440 NO BE Page I 22Page I 22
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