corporate presentation 2014 - jefferies group · 2014. 12. 2. · market cap increased by 40 times...

0www.leespharm.com | Stock Code: 950 | +852 2314 1282

Nov 2014

Corporate

Presentation

* For identification purpose only 僅供識別

1

The Company

Lee’s Pharmaceutical Holdings Limited

is a fully integrated specialty pharma in China

focused on cardiovascular, cancer and

other key disease areas.

2

Key Milestones and Awards

• Launch of first product - Defibrase®

• Established operation in China

• Launch of Livaracine®

• Launch of Yallaferon®

• Listing on the HK GEM

• Launch of Carnitene® from Sigma-Tau

• ZHAOKE became wholly-owned

• Launch of Slounase®

• Launch of Eyprotor®

• VIVO becomes strategic investor

• Transfer of listing to Main Board (0950)

• FIDELITY becomes strategic investor

• Honor of【Forbes】200 Best in Asia Pacificfor three consecutive years since 2011

• Honor of【Deloitte】500 Best in Asia-Pacific

• Awards for innovative Anfibatide

• GL Trade becomes strategic investor

1994

1997

1998

2001

2002

2003

2004

20052006

20082009

20102011

20122013

• Launch of L-Carnitine Oral

• Launch of Remodulin®

• SIGMA-TAU becomes strategic shareholder

Honor of【Forbes】200 Best in Asia Pacific for three consecutive years

2014

• List of strongest 42 Innovative Enterprises in China

• Inclusion to MSCI China Index

3

>30% Annual Growth in Past 7 Years

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

10,346 11,644 18,498 30,395 38,528 43,53176,712

125,421

173,837

255,810

399,685

534,333

696,953

0

100000

200000

300000

400000

500000

600000

700000

800000

HK$ '000

Turnover increased by 70 times since listing

4

Listing on HK GEM on the 15 July 2002

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Nov

Transfer of listing to Main Board on 14 May 2010

13

12

11

10

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8

7

6

5

4

3

2

1

0

Market cap increased by 40 times since listing

Listed on Hong Kong Stock Exchange

Market Capitalization as at 14.11.2014: HK$6.68 billion

Lee's Pharmaceutical Holdings Ltd. (0950HK)

Prev Close (14th Nov, 2014) HK$12.70

At Launch (15th July, 2002) HK$0.40

55

The Financials

6

HK$’0006 months ended

30 Jun 2014

6 months ended

30 Jun 2013Change

Turnover 442,716 334,769 + 32.2%

Gross Profit 311,467 238,227 + 30.7%

Gross Profit Margin (%) 70.4% 71.2% - 0.8ppt

Profit from Operations 106,273 86,941 + 22.2%

EBITDA 120,086 95,008 + 26.4%

Profit Attributable to Shareholders

of the Company 87,073 73,754 + 18.1%

Earnings per Share - Basic (HK

cents) 16.07 14.14 + 13.6%

Financial Highlights

6

7

Balance Sheet

HK$’0006 Months ended

30 Jun 2014

Year ended

31 Dec 2013

Inventories 98,448 117,881

Trade Receivables 101,731 78,320

Cash and Bank Balances 384,067 381,062

Trade Payables 39,386 36,493

Bank Borrowing 60,683 69,468

Shareholder’s Fund 839,322 786,005

7

8

Key Indicator

8

6 Months ended

30 Jun 2014

Year ended

31 Dec 2013

Current Ratio 2.55 2.36

Quick Ratio 2.17 1.92

Return on Assets 7% 13%

Return on Equity 10% 19%

Stock Turnover Days 149 days 171 days

Trade Debtor Turnover Days 37 days 39 days

Debt / Equity 0.37 0.40

99

The Strategies

10

The Strategies

New Matrix for Pipeline Building

Hybrid Engine Model for Sales & Marketing

11

New Matrix for Pipeline Building

Two Anchors

Two Bridges

1. Branded Generics Development

2. Proprietary Drugs Development

1. Mature Products Registration and Importation

2. Late Stage Products Development with Global Application

12

Pipeline–Focused Therapeutic Areas

Cardiovascular

Diseases

Gynecological

Diseases

Oncology

Ophthalmology

Dermatological

Diseases

13

Branded Generics Development (1)

• Leverage on Scinopharm’s strength in

API synthesis and production

• Leverage on Group’s capability in finished product development in

selected areas

• Focus on First-Generic approval for difficult molecules and neglected areas

• Low regulatory risk and shorter development time

Branded Generics

Development Rationale

14

Branded Generics Development (2)

• Much lower regulatory bundle

• Predictable market potential

• Quicker market access

• Shorter Ramp up time

Branded Generics

• Much lower regulatory hurdle



• Shorter ramp up time

Market Prospect in China

15

Product Name Indication StatusIDL Approval: Expected Date

Cyclosporine Dry Eye NDA Submitted Q4, 2016

Travoprost Glaucoma Preclinical underway Q2, 2018

Bimatoprost Glaucoma Preclinical underway Q2, 2018

Prostaglandin E2 Induce labor Preclinical underway Q3, 2018

Fondaparinux Anti-Thrombotic Preclinical underway Q4, 2018

Branded Generics products under development

16

Proprietary Drugs Development (1)





Branded Generics

• Government policies on regulatory and

reimbursement favors proprietary drugs development

• Remain at the forefront of biomedical

research & development

• Leverage on partner’s unique expertise


17

Proprietary Drugs Development (2)





Branded Generics

• Complete differentiation

without pricing pressure and tender competition

• Unmet medical need with

significant market potential

• Mid to long term development with higher regulatory risk


Different

18

Product Name Indication StatusIDL Approval:Expected Date

PL2200 Aspirin Anti-Thrombotic Phase I ongoing Q3, 2017

Rostafuroxin Hypertension Phase IIb ongoing Q4, 2017

Istaroxime Acute Heart Failure Phase IIb ongoing Q4, 2017

LQ-7 Corneal Ulcer IND review underway Q4, 2017

Anfibatide Prevent thrombosis Phase IIb about to start Q1, 2018

Thymosin Beta 4 Dry Eye Phase II ongoing Q2, 2018

Gimatecan Ovarian Cancer Phase III application submitted Q2, 2018

PDL1 Monoclonal Antibody Lung Cancer Preclinical underway Q1, 2019

AK-12 Peptide Psoriasis Preclinical underway Q2, 2019

Combination Gel Acne Phase I & II ongoing Q2, 2019

Proprietary Drugs under Development

19

Mature Products Registration & Importation (1)





Branded Generics

• Low regulatory risk with approval record

• Medium development time

• Clinical development program more predictable


20

Mature Products Registration & Importation (2)





Branded Generics

• Imported drugs still command certain

quality/price premium in the market place

• Easier adoption by doctors with

overseas prescription experience

• Niche areas where unmet medical need is great with fair market potential


21

Product Name Indication Registration Study

Status

IDL Approval:

Expected Date

Mictonorm® Urinary incontinence Completed( Approved )

Nov 2014

Nicetile® Chemo-induced peripheral neuropathy Completed Q1, 2015

Dromos® PAD Completed Q1, 2015

Natulan® Hodgkin’s disease Seek waiver Q3, 2015

Trittico® Depressive disorders Completed Q4, 2015

Nerixia® Osteogenesis Imperfecta Seek waiver Q1, 2016

Unidrox® Respiratory tract infections Ongoing Q1, 2016

Kalbitor® Acute attacks of HAE Seek waiver Q2, 2016

Hyalgan® Traumatic & degenerative joint pathologies Under planning Q3, 2016

Lutrate ® Reduce testosterone Under registration Q3, 2016

INOmax® Hypoxic respiratory failure Under preparation Q1, 2017

Cholecalciferol Vitamin D deficiency Under preparation Q4, 2017

Mature Products under Registration

22

Late Stage Products Development with Global Application (1)





Branded Generics

• Near to medium term opportunity

• Global clinical development standards being followed

• Access to late stage proprietary

products with significant market potential


23

Late Stage Products Development with Global Application (2)





Branded Generics

• Time to market is relatively shorter

• Market access will be relatively fast

• Market size will be substantial


24

Product Indication StatusIDL Approval:Expected Date

Betrixaban Venous Thromboembolism Under discussion Q2, 2017

JX-594 Liver Cancer Under discussion Q2, 2018

Late Stage Products Development with Global Application

Global Phase III Application

25

Expected Development Timeline

2014 2015 2016 2017 2018 2019

Nov Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2

Branded

Generics

Proprietary

Drugs

Mature

Products

Late Stage Development

2626

Pipeline

Highlights

27

Antiplatelet• First in class anti-platelet 1b antagonist

Patent• US Patent granted

Phase II• Phase II study ongoing

Awards• Hong Kong Awards of Industries – Technological Achievement Award

Highlights of selected products (1)

Anfibatide

28

Anfibatide

安菲博肽

Glycoprotein 1b-IX-V comples

Anfibatide

29

Disulfide bond

Structure and Crystal Culture

Anfibatide

30

In vivo study in prevention of thrombosis

Anfibatide

31

In vivo study in treatment of thrombosis

video

Anfibatide

CONTROLANFIBATIDE

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32

Istaroxime

Istaroxime dual mechanism of action results in:• luso-inotropic activity• improved efficiency of cardiac contraction• lower pro-arrhythmic effect vs. digoxin

Due to its high metabolism and fast clearance, Istaroxime has been targeted

to the intravenous treatment of Acute Heart Failure Syndrome

Highlights of selected products (2)

Current Status: Phase IIb Study

33

Molecular Mechanism of Action

CONFIDENTIAL

Istaroxime

34

Istaroxime has been shown to be a luso-inotropic agent in a Ph.IIa trial (HORIZON-HF)

Increased cardiac indexDecreased heart rate

Decreased PCWP Increased systolic BP

Istaroxime

3535

The Products

36

The Company

Launch of Defibrase®

Launch of Livaracine®

Launch of Yallaferon®

Launch of Slounase®

Launch of Eyprotor®

For viral-infected venereal diseases

For reduction of bleeding

For cornea ulcer

For cerebral ischemic stroke

For heart diseases & other cardiovascular diseases

Focus on In-house Drug Development

2008

2006

2001

1998

1997

Launch of 5 self-developed products

37

Launch of Imported Products

Brand Product Name IndicationLaunch

Year

Carnitene® L-Carnitine Injection Cardiac diseases, myocardial ischemia 2003

Ferplex® Iron Proteinsuccinylate sideropenic anaemias 2007

Zanidip® Lercanidipine Hypertension 1Q 2010

Dafnegin® Ciclopirox Olamine Candidiasis 1Q 2010

Veloderm® Hemicellulose dressing Burns and wound healing 1Q 2010

Gaslon® N Irsogladine Maleate Tablet Gastric ulcer 3Q 2011

Hyalofemme® Vaginal epithelium Vaginal dryness of various origin 2Q 2012

L-Carnitine Oral Solution L-Carnitine L-carnitine deficiency 4Q 2013

Remodulin® Treprostinil PAH 2Q 2014

38

Revenue Analysis of Launched Products

39

The Strategies

Well established Distributors Network

Newly established Direct Sales Force

Hybrid Engine Model for Sales & Marketing

4040

The

Market Access

Capabilities

in China

41

Market Access Team

4. Partner with major wholesalers

3. Hospital formulary access

2. Central & provincial level pricing, reimbursement and tenders

1. 10 persons team strategically located throughout China

42

70 professional promoters for business

development

Cover more than 5,000 hospitals and all

provinces in China

Partner with over 700 local distributors

A win-win partnership with local

distributors

Responsible for market development

Well Established Distributors Network

43

Newly established Direct Sales Force

Strong 200 members managed as

four geographic teams.

Current coverage: 23 major

cities.

State-of-art customer

management system

implemented.

Focus on Zanidip® now and move

forward to other key pipeline

products.

4444

The R&D

Capabilities

45

Regulatory & Clinical Team

9 professionals fully devoted to dossier translation and

submission preparation

More than 30 years combined regulatory experience

Experience in regulatory filing for clinical trial approval in China

A clinical development team composed of 25 professionals with

5 trained physicians

Broad network of major clinical centers in China

Over 25 clinical studies conducted in China since 1998

46

Product Number of Patients Indication Year

Defibrase® 700 Acute Ischemic Stroke 1998

Yallaferon® 144 Prevention of recurrence of Genital warts 1998

Liveracine® 200 Prevention of deep vein thrombosis 1998

Yallaferon® 122 Genital and oral herpes 1999

Livaracine® 50 Anticoagulation in Hemodialysis 1999

KPV Peptide 33 Vaginal candidiasis 2001

Yallaferon® 240 Herpes Zoster 2003

Yallaferon® 320 Cervicitis and cervical erosion 2004

Eyprotor® 300 Cornea ulcer 2005

Bemiparin 144 Anti-coagulation in Hemodialysis 2007

Horus® stent 44 Ischemic heart diseases 2007

Slounase® 300 Reduction of bleeding in surgery 2007

Bemiparin 144 Prevention of DVT 2008

The Clinical Capabilities

Over 25 Clinical Studies completed in China since 1998

47

Product Number of Patients Indication Year

Veloderm® 50 Skin graft 2009

Declotana® Phase I Unstable Angina 2010

Acetyl-L-Carnitine 240 CIPN 2010

Propionyl-L-Carnitine 239 PAD 2010

Hyalofemme® 50 Vaginal epithelium 2010

Mictonorm® 240 Urinary incontinence 2011

L-Carnitine injection 400 Heart failure 2011

Zanidip® 278 Hypertension 2012

Treprostinil 300 PAH 2013

Trittico® 378 Depression 2013

Over 25 Clinical Studies completed in China since 1998 (cont’d)

The Clinical Capabilities

4848

The

Manufacturing

Capabilities

49

GMP Facilities

4,600 M2 manufacturing area

Different dosage forms: topical gel, eye gel/drop, lyophilized injection, LMWH API

New China GMP standard

Full operational

Hefei Facility

Nansha Facility

Total area of 62,000 M2

Hub for China manufacturing, sales & marketing, R&D, etc.

All dosage forms including aseptic and septic one, solution & liquid

Enter operational gradually

50

Zhaoke Lianfa in Nansha site

New GSP compliant warehouse

Passed the audit by the local CFDA

Leverage on its new location to consolidate importation

and logistic services for the Group’s in-license products

5151

The Milestones

52

2014–Milestones & 2015–Prospect

The Group’s associated company Powder Pharmaceuticals Incorporated(“PPI”) successfully obtained approval from US FDA for its manufacturingsite in Hong Kong, and Zingo® has been re-launched in US in February.

Approval of Mictonorm® (propiverine) is obtained in November 2014

Completion of Phase IIb study of Istaroxime

Completion of Stage IIa study of Anfibatide

Completion of Phase I & Phase II study of Gimatecan for ovarian cancer

Initiation of Phase IIb study (China arm) of Rostafuroxin

Initiation of Phase III global study of Betrixaban for treating thrombosis

Initiation of stage IIb study of Anfibatide

Maintain the growth momentum of the Company

53

Company Vision

Continue the growth momentum in

both top line & bottom line

Fine tune the Dual Engine for Building

Pipeline to focus on key areas

Become the one of the best performing specialty pharma

companies in China to deliver superb return for its shareholders

54

Your Partner in China

LEE’S PHARMACEUTICAL

HOLDINGS LIMITED

corporate presentation 2014 - jefferies group · 2014. 12. 2. · market cap increased by 40 times...

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