specialized in ophthalmology...source: united nations, world population prospects: 2015 revision...

28
Specialized in Ophthalmology Akira Kurokawa President & CEO Santen Pharmaceutical Co., Ltd. January 11, 2016 J.P. Morgan Healthcare Conference

Upload: others

Post on 22-May-2020

7 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Specialized in Ophthalmology

Akira Kurokawa President & CEO Santen Pharmaceutical Co., Ltd.

January 11, 2016

J.P. Morgan Healthcare Conference

Page 2: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Disclosure Notice Information given in presentation contains certain forward-looking statements concerning forecasts, projections and plans whose realization is subject to risk and uncertainty from a variety of sources. Actual results may differ significantly from forecasts.

Business performance and financial condition are subject to the effects of medical regulatory changes made by the governments of Japan and other nations concerning medical insurance, drug pricing and other systems, and to fluctuations in market variables such as interest rates and foreign exchange rates.

The process of drug research and development from discovery to final approval and sales is long, complex and uncertain. Individual compounds are subject to a multitude of uncertainties, including the termination of clinical development at various stages and the non-approval of products after a regulatory filing has been submitted. Forecasts and projections concerning new products take into account assumptions concerning the development pipelines of other companies and any co-promotion agreements, existing or planned. The success or failure of such agreements could affect business performance and financial condition significantly.

Business performance and financial conditions could be affected significantly by a substantial drop in sales of a major drug, either currently marketed or expected to be launched, due to termination of sales as a result of factors such as patent expiry and complications, product defects or unforeseen side effects. Santen Pharmaceutical also sells numerous products under sales and/or manufacturing license from other companies. Business performance could be affected significantly by changes in the terms and conditions of agreements and/or the non-renewal of agreements.

Santen Pharmaceutical is reliant on specific companies for supplies of certain raw materials used in production. Business performance could be affected significantly by the suspension or termination of supplies of such raw materials if such and event were to adversely affect supply capabilities for related final products.

This presentation includes discussions of certain Santen products marketed in certain markets and compounds in clinical trials, as well as competitors and their products and compounds in clinical trials which are given for illustrative purposes only. Such discussions may include views subject to data interpretation that may or may not be views shared by regulatory authorities in the various regions in which the Company operates.

2

Page 3: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Santen’s Core Values

3

By focusing on ophthalmology, Santen develops unique

scientific knowledge and organizational capabilities that

contribute to the well-being of patients, their loved ones and

consequently to society.

Page 4: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Santen is Specialized in Ophthalmology

4

Focus on unmet medical needs in ophthalmology

Growing ophthalmology market

Specialized in ophthalmology

Santen’s growth strategy

Page 5: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Santen is Specialized in Ophthalmology

5

Focus on unmet medical needs in ophthalmology

Growing ophthalmology market

Specialized in ophthalmology

Santen’s growth strategy

Page 6: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

0

5

10

15

20

25

2006 2007 2008 2009 2010 2011 2012 2013 2014

Sustained Growth in Ophthalmology Worldwide

Source: ©2015 IMS Health, Calculated based on IMS-MIDAS 2006-2014 data, reprinted with permission

RETINA

GLAUCOMA

DRY EYE

CAGR

34%

World Ophthalmology Market by Therapeutic Category

OPHTHALMOLOGY

MARKET 11%

13%

5%

6

(USD billions)

Page 7: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

REST OF WORLD 8%*

ASIA 11%*

NORTH, E. EUROPE, RUSSIA 9%*

W. EUROPE** 4%*

U.S. 5%

JAPAN 4%

Market Outlook: Continuing Growth

7

Source: Santen estimation *Compound annual growth rate, **UK, France, Germany, Spain, Italy

35%

15%

11%

13%

16%

2017

10%

17%

36%

25

12%

9%

15%

2013

20

12%

39%

18%

11% 8%

14%

2020

30

10%

AVERAGE ANNUAL GROWTH RATE 6%

Global Prescription Ophthalmic Market

(USD billions)

Page 8: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

The Population is Aging Worldwide

8

Source: United Nations, World Population Prospects: 2015 Revision

Population Aged 65+

0%

10%

20%

30%

40%19

50

19

55

19

60

19

65

19

70

19

75

19

80

19

85

19

90

19

95

20

00

20

05

20

10

20

15

20

20

20

25

20

30

20

35

20

40

20

45

20

50

20

55

20

60

JAPAN

WESTERN EUROPE

U.S.

REST OF WORLD

Page 9: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Santen is Specialized in Ophthalmology

9

Focus on unmet medical needs in ophthalmology

Growing ophthalmology market

Specialized in ophthalmology

Santen’s growth strategy

Page 10: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Focused on All Ophthalmic Therapeutic Areas

Source: Publicly available information

Santen Alcon/Novartis

B&L/Valeant

Allergan

Pfizer

Genentech

Regeneron/Bayer

Abbott/Solvay

Sanofi

Company Retina Glaucoma Dry eye Infection Allergy Cataract

Santen offers a full range of ophthalmology treatments, including areas with high unmet medical needs.

10

Page 11: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Specializing Our Business and R&D in Ophthalmology

2012

Novagali Pharma acquisition

• Strengthened R&D, including Novasorb® formulation technology

• IKERVIS (now launched in several European countries)

MSD ophthalmology

product acquisition

2014

• Acquired product sales: 21.5b yen (FY15 FCT)

• Reinforced global presence

• Accelerated EU and Asia growth

• Increased profitability

Anti-rheumatic (RA) pharmaceutical

business divestment

2015

• 45b yen received to support future investment

7% RA

93% Op

100% Ophthalmology

11

Page 12: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Santen is Specialized in Ophthalmology

12

Focus on unmet medical needs in ophthalmology

Growing ophthalmology market

Specialized in ophthalmology

Santen’s growth strategy

Page 13: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

VISION 2020: Establishing a Global Presence as a Specialized Pharmaceutical Company

13

Establish and reinforce overseas business platforms

Strengthen domestic business platform and competitiveness

Maximize new product value globally

2011 2020

Global Top 3

#1 in Asia by 2020

Page 14: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

77% 4%

10%

9%

Santen is the Market Leader in Japan

14

$1.29 Billion, Sales Composition (FY14*, $1=125yen)

0%

10%

20%

30%

40%

50%

FY01 FY03 FY05 FY07 FY09 FY11 FY13 FY151H

43%

Market Share Leader in Japan

JAPAN

EUROPE

U.S.

ASIA

Source: ©2015 IMS Health, Calculated based on IMS-JPM 2001-2015 data, reprinted with permission

*FY14: Fiscal year ended March 31, 2015

Page 15: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

0

10

20

30

40

50

60

FY11 FY12 FY13 FY14 FY15e

(JPY billions)

Driving Sales Growth in Europe and Asia

15

• ASIA: Growth led by China +19% in 1H FY15 (local currency)

• EUROPE: Sales boosted by ophthalmic products from MSD since FY14

ASIA

EUROPE

CAGR

FY11-FY15

37%

30%

Overseas Sales: Double Digit Growth

Page 16: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Gaining Share in High-Growth Asia Region

• China: over 60% of Asia revenue

• Building out own-sales in ASEAN countries

• Above-market growth toward goal to become Asia #1

• Growth drivers: CRAVIT (anti-infection) and HYALEIN (dry eye)

• Growth from pipeline: TAPROS (glaucoma) and IKERVIS (severe keratitis with dry eye)

16

600

FY14(Act) FY17(MTP)

Sales Target China (CHY Millions)

1,000

Page 17: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

102

220

FY14(Act) FY17(MTP)

Sales Target Europe (EUR Millions)

Expanded European Operations is a Growth Driver

• Establishing position as differentiated player / best-partner

• New regional HQ in Geneva leading pan-European business platform

• Accelerating new product growth and success with acquired MSD products

• Successful launches and further rollout of IKERVIS across Europe

17

Page 18: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Mid-Term Plan to Achieve Above-Market Growth

18

11.5%

0

50

100

150

200

FY11 FY12 FY13 FY14 FY15 e

(JPY Billions)

FY17 e

13.0% ROE

SALES

OPERATING PROFIT

IFRS adopted from FY14 *Core OP shown for FY14 and FY15

45.0

160

40.3*

146 123

39.1* 30.4

116 94

24.6 26.7

88

114 119

146 162

187

205

Page 19: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Coming Products to Drive Growth Santen Products Targeting Unmet Medical Needs

19

NICE: The National Institute for Health and Clinical Excellence; HTA: Health Technology Assessment authority

IKERVIS DE-109

• Treatment for severe keratitis in patients with dry eye disease

• First to market in Europe

• Received positive recommendation from NICE (1st HTA authority in Europe)

• Treatment for patients with chronic noninfectious uveitis of the posterior segment (NIU-PS)

• Pre-launch initiatives underway

• EMA now reviewing EU submission

• US Phase 3 clinical trials ongoing

Page 20: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Santen is Specialized in Ophthalmology

20

Focus on unmet medical needs in ophthalmology

Growing ophthalmology market

Specialized in ophthalmology

Santen’s growth strategy

Page 21: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

R&D for the Next Decade

21

Reduce time to launch; Faster with focus on the right products to the right patients

Target and address region-specific

unmet medical needs

Significantly improve

probability of technical success in all target disease areas

UMN TTL PTS

Santen’s R&D Transformation

Page 22: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

R&D Strategy: Raise Competitiveness in Specialty Area of Ophthalmology

22

*Any new product candidate that has POC in human with ophthalmic or other systemic indications

Focus on differentiated life-cycle management

Improve PTS with pathobiology and unmet needs through translational research, biomarkers and diagnostics

Boost productivity by prioritizing Best-in-Class* programs

Pursue partnered R&D through clearly defined business development and in-licensing

Page 23: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Addressing the Unmet Needs of a Changing World

23

Disease areas with region-specific needs

Asia Developing

World

Developed World Worldwide

Myopia Infectious disease

Age related diseases, Dry eye, Chronic illness,

Complications of diabetes

Orphan diseases

Page 24: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Unmet Medical Needs in Ophthalmology

24

Source: Office of Pharmaceutical Industry Research in Japan

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Diabetic Retinopathy

Age-related Macular

Degeneration

Glaucoma

Alzheimer's Disease

Cerebral Hemorrhage

Colorectal Cancer

Diabetes Rheumatoid Arthritis

Co

ntr

ibu

tio

n o

f th

e d

rug

f

or

the t

reatm

en

t

Treatment satisfaction

Arrhythmia HIV

Page 25: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

Santen Pipeline Targeting Unmet Needs

25

Excludes GE products. LCM products includes those to be launched in multiple regions. Feasibility of clinical trials of Santen S.A.S. is being assessed.

Launched in FY2011-13

Approval Timing FY2014-17

To be Approved FY2018-

Glaucoma TAPROS Mini DE-111 (Tafluprost / Timolol (combination))

DE-117 (EP2 Agonist)

DE-090 (Lomerizine HCl)

Corneal and Conjunctival Disease (Dry Eye)

IKERVIS (Cyclosporin)

Retinal Disease, Uveitis

EYLEA Opsiria (Sirolimus)

DE-120 (VEGF/PDGF inhibitor)

DE-122 (Anti-endoglin antibodies)

Other Infection, Allergy

ALESION VEKACIA (Cyclosporin)

CRAVIT 1.5%

Global

Japan (Asia)

Page 27: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5

In Conclusion, Santen Is…

27

Specialized in ophthalmology

Geographic and product growth drivers in place

Targeting and addressing unmet medical needs

Focused R&D strategy with a strong late-stage pipeline

Ready to make investments for further growth

Page 28: Specialized in Ophthalmology...Source: United Nations, World Population Prospects: 2015 Revision Population Aged 65+ 0% 10% 20% 30% 40% 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5 0 5