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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

2

3

4

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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

  • 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 PIVchallenges

  • 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

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

  • • 65% rev. growth from hospital channels thanks to new launches and oncology share gain

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KR +3%

  • Eased anti-obesity competition in 2H17

  • • 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
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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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