LOTUS PHARMACEUTICAL · Operating synergy emerging following transitions in portfolio and S&M...

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Page I 1 LOTUS PHARMACEUTICAL BUILDING A REGIONAL LEADER Nov 2017

Transcript of LOTUS PHARMACEUTICAL · Operating synergy emerging following transitions in portfolio and S&M...

Page 1: LOTUS PHARMACEUTICAL · Operating synergy emerging following transitions in portfolio and S&M strategies OPEX % 69% 50% ... 12% 12% 10% 6% 5% 8% 5% FY2014 FY2015 FY2016 9M17 52% 3,084

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LOTUS PHARMACEUTICALBUILDING A REGIONAL LEADER

Nov 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

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Company Overview

3Q 2017 Financial Results

Recent Developments

Profitable Growth

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COMPANY OVERVIEW

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LOTUS PHARMACEUTICAL IS AN APAC GENERICS LEADER

1

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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

1

2

3

4

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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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36% 34% 34%30% 30% 28% 29%

41.7%

26%22% 24%

12%12% 10%

12% 10% 14%16%

8.9%

10%10% 9%

4%4% 7%

7%4%

4%6%

15.7%

6%

4%6%

5.4% 6.8%11.4%

8.5% 10.4%12.9%

5.6%

-13.0%

5.6%10.6% 10.6%

Q1'15 Q2'15 Q3'15 Q4'15 Q1'16 Q2'16 Q3'16 Q4'16 Q1'17 Q2'17 Q3'17

SM GA RD OPM

THE PAST 2 YEARS WERE TRANSITIONAL

Operating synergy emerging following transitions in portfolio and S&M strategies

OPEX % 69% 50%

1,590 2,780Total OPEX

(NT$mn)

50% 50% 49%

669 711 725

44%

631

52%

675

46%

742

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51%

729

43%

33% 32%

24%

20%

12% 12%

10%

6%

5% 8%

5%

FY2014 FY2015 FY2016 9M17

52%

3,084

66%

982

42%

592

39%

1,788

37%

580

39%

616

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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

• Adjustment 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

• Become category leaders in

APAC market

• Strengthen balance sheet

• Balance organic and

inorganic growth

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EXPANDING REVENUE AND GROSS MARGIN ARE OUR TOP PRIORITIES

Revenue (NT$m) Gross margin

663

12941337

14171473

1425

1594

14041479

1436

1577 1579

Q4'14Q1'15Q2'15Q3'15Q4'15Q1'16Q2'16Q3'16Q4'16Q1'17Q2'17Q3'17

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43%

58% 57%

62%

58%55%

59%57%

54%

47% 47%50%

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3Q 2017 FINANCIAL RESULTS

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Unit: NT$000 3Q 2017 % 3Q 2016 % 2Q 2017 % QoQ YoY

REVENUE $1,579,129 100 $1,403,603 100 $1,577,430 100 0.11% 12.51%

COGS 795,802 50 596,618 42 829,640 53 -4.08% 33.39%

GROSS PROFIT 783,327 50 806,985 58 747,790 47 4.75% -2.93%

OPEX

S&M 378,099 24 411,211 29 350,393 22 7.91% -8.05%

G&A 146,660 9 227,403 16 160,021 10 -8.35% -35.51%

R&D 91,065 6 90,215 7 69,653 4 30.74% 0.94%

Total OPEX 615,824 39 728,829 52 580,067 37 6.16% -15.51%

OPERATING PROFIT (LOSS) 167,503 11 78,156 6 167,723 11 -0.13% 114.32%

NON-OP INCOME & EXP

Finance costs -68,104 -4 -70,303 -5 -63,341 -4 7.52% -3.13%

Others 17,445 1 10,525 1 1,774 0 883.4% 65.75%

Total non-op expenses, net -50,659 -3 -59,778 -4 -61,567 -4 -17.72% -15.25%

INCOME BEFORE TAX 116,844 8 18,378 2 106,156 7 10% 535.78%

INCOME TAX EXPENSE

(BENEFIT)47,752 3 38,133 3 48,632 3 -2% 25.22%

NET ERANINGS (LOSS) 69,092 4 -19,755 1 57,524 4 20% NA

EPS $0.20 -$0.14 $0.15 33% NA

GROSS MARGIN RECOVERY UNDERWAY

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RECENT DEVELOPMENTS

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84.5%

10.4%

3.1% 2.0%

2017 IS THE TIPPING POINT OF GEOGRAPHIC DIVERSIFICATION

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2016FY 9M2017

While Korea remains our backbone thanks to its market potential and favorable

regulatory environment, Lotus has started to balance its geographic exposure by

growing Taiwan domestic and export market

2017

85.4%

8.0%

2.6% 4.0%

Korea

Taiwan

Export

India CRO

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NEW PRODUCT LAUNCHES IN OUR TURF SECURE LONG TERM GROWTH

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Product Indication YTD (NT$mn) YoY (%) Remarks

1 Goserelin (Zoladex) Breast cancer 乳癌 404.8 -Exclusive marketing alliance with

AstraZeneca KR; launched Oct’16

2 Sarpogrelate Anticoagulant 抗凝血 303.2 -2% Dosage improved to 1/day

3 Rosuvastatin/EzetimibeCardiovascular降血脂與膽固醇

224. +51% FDC; launched in 1Q16

4Calcium Polystyrene

SulfonateNephrology 腎臟病 270.3 -4%

5 Seroquel (Quetiapine) Schizophrenia 精神分裂症 233.2 -10%Exclusive marketing alliance with

AstraZeneca KR; launched Oct’15

6 Desogestrel/EE (Mercilon)Oral contraceptive

口服避孕藥204.9 +52%

Acquired from Bayer; launched in

May’16

7 Phentermine Anti-obesity 減肥 190.9 -25%

8 Bicalutamide Prostate cancer 攝護腺癌 167.4 +294%Exclusive marketing alliance with

AstraZeneca KR; launched Oct’16

9 Phendimentrazine Anti-obesity 抑制食慾 142.8 -24%

10 Anastrozole (Arimidex) Oncology 癌症 139.4 -Exclusive marketing alliance with

AstraZeneca KR; launched 4Q’16

11 Zoledronic Acid (Aclasta) Osteoporosis 骨質疏鬆症 114.4 -Acquired from Novartis; launched

Apr’17; TW product

12 Orlistat Anti-obesity 減肥 114.4 -39%

13 Topiramate CNS 抗癲癇 58.7 -36%

14 Diltiazem Cardiovascular 降血壓 58.6 -1%

15 Bethanechol Chloride Bladder problem 泌尿道 43.6 +28%

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WE ARE ALSO MAKING GREAT PROGRESS IN INNOVATION

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2017 R&D Projects for

Export Markets

LATE PHASEVinorelbine 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

5+ Expected 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

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WE BEGAN TO SEE SIGNIFICANT PROGRESS IN LOTUS ONCOLOGY FRANCHISE

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Lotus officially started building its global oncology franchise through self

developed “fast follower” products, exclusive marketing alliances with brands,

and CMO projects with APAC biotech star-ups

2017

High Potency Products

Cytotoxics

Hormones

TabletsHard gel capsules

Softgelcapsules

Why are high potency products key to growth?

• Oncology drugs are dominating US approvals: According to

Evercore, cancer drug approvals from 2012 to 2016 in the US

were 50, doubling from 2007 to 2011 numbers and >200%

higher than treatments for other therapeutic areas

• By 2022, global TAM for top 15 oncology drugs will be US$

90 billion small molecules and biosimilar combined according

to IMS

• By 2020, oncology is the only therapeutic area that will have

double digit CAGR according to EvaluatePharma

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PROFITABLE GROWTH

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OUR GOAL IN THE NEXT 3 YEARS IS TO DELIVER PROFITABLE GROWTH

Back to Basics

Value Differentiation

Geared Up For The Future

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Profitable

Growth

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BACK TO BASICS

• Strongest Portfolio

• Best Service

• Best Quality

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28%

22%

4%3%2%

41%

Anti-obesity/lifestyle & Gastrointestinal productsCardiovascularCentral Nervous SystemOncologyWomen healthcare

STRONGEST PORTFOLIO SURROUNDING 5 SPECIALTY AREAS

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Note: Others include respiratory system, pain killers, nephrology, anti-inflammatory and so on

2016A to 2020F therapeutic area revenue breakdown

2016A

19%

19%

8%17%

6%

31%

9M2017

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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

1

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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

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

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

1

2

3

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BEST QUALITY MAKES US THE MOST PREFERRED PARTNER OF OUR CUSTOMERS

Lotus quality record

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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

• Shortest Time to Market

• High Value Pipeline

• Leader in Special Dosage

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Capture global generics growth through Alvogen’s 3 regional platforms

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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

IMS “Global Spending On Medicines 2014-2020”

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

LEVERAGE ALVOGEN‘S GLOBAL SALES NETWORK TO CROSS SELL

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THEREFORE, LOTUS CAN ACHIEVE SHORTEST TIME TO MARKET

• Ability to leverage customer demand information across the group

• Robust regional supply chain network

✓ Prompt and seamless coordination of complex supply and distribution network

✓ Supported by 5 manufacturing sites across the Lotus and Alvogen group

• Ability to deliver 97% order next-day without major stock-outs

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INN/Scope Indication 2H’17 2018 2019 2020

Budesonide ER /US GI

結腸潰瘍

Buprenorphine

Naloxone /US

Addiction

戒毒

Methotrexate /US Chemo

癌症

Gefitinib /EUNon-small-cell lung

cancer; Inhibitor

非小細胞肺癌

LP083 ULD /JP

(CDMO project, strength ext.)

Women health

女性保健

Acarbose /CN Antidiabetic

糖尿病

Vinorelbine

softgel capsule /EU

Breast cancer

乳癌

Lenalidomide /US Multiple Myeloma

血癌

Lenlidomide /ROW Multiple Myeloma

血癌

HIGH VALUE PIPELINE TARGETING EXPORT MARKETS FUELS GROWTH

Export timeline from now – 2020 approval out-license shipment

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LOTUS PHARMACEUTICAL IS THE REGIONAL LEADER IN SPECIAL DOSAGE

Soft Gel Manufacturing

• Investment in dedicated manufacturing area starting 2009 and

current capacity at 500mn capsules / year

• State of the Art equipment

✓ Closed melting and mixing Tanks

✓ PharmaGel GKF-072 filling machine

✓ Fully automatic visual inspection

• Extensive soft gel manufacturing experience in

✓ 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

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GEARED UP FOR THE FUTURE

• Biosimilar Ready

• M&A Mode Always On

• Winning Business Strategies

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0.1 0.1 0.2 0.3 0.6 1.5

3.7

6.5

9.1

10.6 11.1

12.1 12.5 12.7

0.4 0.5 0.6 0.7 0.9

1.1

1.5

2.2

2.8

3.4

3.8

4.2

4.9 4.8

0.1 0.1 0.1 0.1 0.2

0.2

0.4

0.6

0.8

1.0

1.2

1.5

1.7 1.9

-

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.0

18.0

20.0

2012 2013 2014 2015 2016F 2017F 2018F 2019F 2020F 2021F 2022F 2023F 2024F 2025F

US Europe ROW

BIOSIMILAR READY

Lotus’ Biosimilar Play

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• Biosimilars have reached an inflection point and we expect very rapid growth from

2017 onwards

• Secured APAC ex. Japan distribution rights of 2 biosimilar products of Alvotech,

Alvogen’s sister company

US$Bn

Source: PharmaCloud

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M&A MODE ALWAYS ON

Pharmaceutical 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% 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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Constantly looking for companies that complements our S&M strategy or portfolio

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AS THE EXPERT IN ASIA, LOTUS HAS A SET OF WINNING BUSINESS STRATEGIES

Being the expert in APAC pharmaceutical market

• We address APAC market through both local sales team and distribution network

• We fulfill the neglected generic needs of key local markets to bring down healthcare cost

for more people

• 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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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

HIGH OPERTIONAL EFFICIENCY

TARGETED PORTFOLIO

ONLY THE BEST PEOPLE