18
Page I 1 LOTUS PHARMACEUTICAL BUILDING A REGIONAL LEADER March 2017

LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

  • Upload
    others

  • View
    5

  • Download
    0

Embed Size (px)

Citation preview

Page 1: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 1

LOTUS PHARMACEUTICALBUILDING A REGIONAL LEADER

March 2017

Page 2: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 2

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.

Page I 2

Page 3: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 3Page I 3

COMPANY OVERVIEW

Page 4: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 4

LOTUS PHARMACEUTICAL IS AN APAC GENERICS LEADER

1

Page I 4

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

Went public in 2010

Lotus Pharmaceutical (1795. TWO) has been listed on Taiwan OTC Stock

Exchange since 2010

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

Page 5: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 5

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

A FAST GROWING GENERICS & SPECIALTY PHARMACEUTICAL POWERHOUSE

Lotus facts

Page I 5

1000+ Employees

3 Manufacturing and R&D Centers

250+ Marketed products

140+ Submissions since 2012

15%

22%

22%

41%

Lotus Taiwan EmployeesTotal: 339

G&A

R&D

S&M

Plant

9%8%

51%

32%

Alvogen Korea Employees Total: 573

G&A

R&D

S&M

Plant

Page 6: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 6

2015-2016

POST MERGERINTEGRATIONPHASE

2017-2018

INITIALGROWTHPHASE

2019~

EXPLOSIVEGROWTHPHASE

AFTER 2.5 YEARS OF INTEGRATION, LOTUS IS ENTERING INTO A GROWTH PHASE

Page I 6

• Plant upgrade in Nantou,

Taiwan

• Successful management

team change

• Portfolio and pipeline

reshape

• Sales and marketing

strategy adjustment

• Solidify local portfolio

through key launches

• Shipments of ANDA

approved drugs start

• Continue to increase

operational efficiency

• Export revenues to

significantly grow from

several successful key PIV-

challenges

• High value products to drive

up gross margin

• Continue to improve

financial structure

Page 7: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 7Page I 7

PROFITABLE GROWTH

Page 8: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 8

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

Back to Basics

Value Differentiation

Page I 8

Profitable

Growth

Page 9: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 9Page I 9

BACK TO BASICS

• Strongest Portfolio

• Best Service

• Best Quality

Page 10: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 10

28%

22%

4%3%

2%

41%

Anti-obesity/lifestyle & Gastrointestinal productsCardiovascularCentral Nervous SystemOncologyWomen healthcare

STRONGEST PORTFOLIO SURROUNDING 5 SPECIALTY AREAS

Page I 10

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

2016E therapeutic area revenue breakdown

2016E

Page 11: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 11

STRONGEST LOCAL PORTFOLIO WITH MARKET SHARE LEADER POSITION

Page I 11

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

Page 12: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 12

LOTUS PHARMACEUTICAL PROVIDES BEST SERVICE IN EVERY ASPECT

1

Page I 12

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

Page 13: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 13

BEST QUALITY MAKES US THE MOST PREFERRED PARTNER OF OUR CUSTOMERS

Lotus quality record

Page I 13

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

Page 14: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 14Page I 14

VALUE DIFFERENTIATION

• Shortest Time to Market

• High Value Pipeline

• Leader in Special Dosage

Page 15: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 15

Capture global generics growth through Alvogen’s 3 regional platforms

Page I 15

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

Page 16: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 16

HIGH VALUE PIPELINE FUELS REVENUE AND PROFITABILITY GROWTH

Export timeline from now – 2020 FDA approval out-license shipment

Page I 16

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

Levonogestrel 0.75mg Contraceptive

避孕

Calcium Acetate

667mg

Nephrology

洗腎

Not disclosed Anti-epilepsy

抗癲癇

Budesonide ER GI

結腸潰瘍

Buprenophine/

Naloxone

Addiction

戒毒

Page 17: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 17

Export timeline from now – 2020 FDA approval out-license shipment

Page I 17

INN Indication 1H’16 2H’16 1H’17 2H’17 2018 2019 2020

Not Disclosed Chemo

癌症

GefitinibNon-small-cell lung

cancer; Inhibitor

非小細胞肺癌

Vinorelbine

softgel capsule

Breast cancer;

Chemo

乳癌

Acarbose Antidiabetic

糖尿病

Not Disclosed Multiple

Myeloma

血癌

Page 18: LOTUS PHARMACEUTICALand pain relief in forms of tablet, capsule, and soft gel capsule The rising generic leader in APAC Lotus is positioned as a regional platform for Alvogen Group

Page I 18

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

Page I 18