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Investor Meeting on FY2016 First Quarter Results and FY2016 Forecasts August 2, 2016 Copyright© 2016 Santen Pharmaceutical Co., Ltd. All rights reserved. Kazuo Koshiji Senior Corporate Officer Chief Financial Officer (CFO) Head of Finance Division

Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

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Page 1: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Investor Meeting on FY2016 First Quarter Results and FY2016 Forecasts

August 2, 2016

Copyright© 2016 Santen Pharmaceutical Co., Ltd. All rights reserved.

Kazuo Koshiji Senior Corporate Officer Chief Financial Officer (CFO) Head of Finance Division

Page 2: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Santen’s Corporate Values

1

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 3: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Long-term Strategic Vision and Growth Targets

2

To Become a Specialized Pharmaceutical Company with a Global Presence

Deep understanding of true customer needs* Distinct advantage against competitors Global competitiveness and presence

*True customer needs: Unmet medical needs of patients, consumers, doctors and healthcare professionals

2020

2017

2013

Ranks #5 globally Overseas sales: 16% of total sales

Overseas sales: 30% of total sales

Become global #3 Overseas sales: 40%-50% of total sales

What we aim to achieve by 2020

“To become a Specialized Pharmaceutical Company with a Global Presence”

Medium-term Goals • Grow business in

Asia/Europe and improve profitability

• Prepare for business expansion in the U.S. and other regions

• Strengthen the Japan business

• Prepare for business expansion in Asia/Europe

Page 4: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

1Q FY2016 Financial Results ended June 30, 2016

3

Page 5: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

1Q FY2016 Consolidated Highlights

4

Revenue and core operating profit increased year-on-year Japan business Prescription pharmaceuticals business rose 4% despite impact from

NHI price revisions and exit from anti-rheumatic pharmaceutical business

Strong growth of revenue from new products and higher-than-expected revenue from long-listed drugs

Double digit growth in OTC revenue though some slowing in growth rate from purchases by visitors to Japan

Overseas business Asia: Decreased 5% due to the yen’s appreciation China: Continued strength as local currency revenue grew 18% Europe: Local currency revenue increased 37% on contribution from

Ikervis and products acquired from US-based Merck

Page 6: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

1Q FY2016 Financial Highlights

5

(JPY billions)

1Q FY15 Actual 1Q FY16

Actual Var. (YoY)

Revenue 48.0 50.0 +4.2%

Core operating profit* 12.2 12.4 +1.2%

Core net profit for the period 8.2 8.8 +6.8%

IFRS basis

Operating profit 10.8 10.8 +0.1%

Net profit for the period 7.5 7.3 -2.9%

* Core operating profit = operating profit + amortization associated with products – other revenue + other expenses (see page 24)

Core basis

Page 7: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

(JPY billions) 1Q FY15 Actual

1Q FY16 Major Changes

Actual Var. (YoY) Revenue 48.0 50.0 +4.2%

Cost of sales (% of revenue)

-17.9 37.2%

-18.4 36.8%

+2.9% -0.5pt

Product mix change ・Japan -1.5pt ・Overseas +1.0pt

SG&A expenses (% of revenue)

-13.3 27.8%

-14.1 28.2%

+5.9% +0.4pt

・Japan -0.6 ・Asia -0.5 ・US/Europe +0.1

R&D expenses (% of revenue)

-4.6 9.6%

-5.2 10.3%

+12.5% +0.8pt

・Japan -0.1 ・Overseas -0.4

Core operating profit (% of revenue)

12.2 25.4%

12.4 24.7%

+1.2% -0.7pt

Amortization on intangible assets associated with products (% of revenue)

-1.4 3.0%

-1.6 3.2%

+10.8% +0.2pt

Other revenue Other expenses

0.1 -0.1

0.1 -0.1

- -11.4%

Operating profit (% of revenue)

10.8 22.5%

10.8 21.6%

+0.1% -0.9pt

Core net profit for the period 8.2 8.8 +6.8% Net profit for the period 7.5 7.3 -2.9%

Currency rates 1Q FY15 Actual 1Q FY16 Actual

US$ JPY 121.51 JPY 108.83

Euro JPY 134.01 JPY 122.53

CNY JPY 19.81 JPY 16.63

Changes in P&L Statement

6

Page 8: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Revenue +2.0 (+4.2%)

Japan +2.0 (+5.4%)

Overseas +0.1 (Currency -1.7)

(+1.0%)

1Q FY15 Actual

1Q FY16 Actual

1Q FY2016 Revenue Change

7

Japan Prescription

pharmaceuticals

Japan OTC

Japan medical devices

Japan others Asia Europe US Merck

NPM*

1Q FY15 32.0 2.4 0.5 0.1 6.3 5.3 0.2 1.2 1Q FY16 33.2 2.9 0.6 0.1 6.0 6.7 0.2 0.2

1Q FY15: 34.9 1Q FY15: 13.0

Var. (YoY)

JPY billions

* NPM (Net Profit Margin): Profit generated from US-based Merck ophthalmic products which Santen has acquired and has consigned them to US-based Merck until the completion of transfer of the underlying marketing rights.

1Q FY16: 36.9 1Q FY16: 13.2

Prescription pharmaceuticals

OTC Medical devices

Europe Merck NPM* US

Asia

Currency -1.0 (China -0.0 (Currency -0.7))

Currency -0.7

Currency -0.0 Currency -0.0

50.0

48.0

+1.2

+0.6

+1.4 -0.3

-1.0

+0.1

-0.0

Revenue

Revenue

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R&D expenses increase

Core operating profit +0.1 (+1.2%)

1Q FY16 Actual

1Q FY15 Actual

1Q FY2016 Core Operating Profit Change

8

Asia Europe US 1Q FY15 2.5 0.6 -0.6 1Q FY16 1.3 0.7 -0.3

Currency -0.5

Currency -0.1

Currency +0.0

Currency +0.3

1QFY15: 2.5 1QFY16: 1.7 1QFY15: 14.3 1QFY16: 15.8

Japan +1.5 (+10.8%)

Overseas -0.8 (Currency -0.5)

(-32.5%)

Japan* US*

Europe*

Asia*

Var. (YoY)

JPY billions

* Company policy on accounting for profit does not allocate certain SG&A and R&D expenses. NPM is distributed by region after operationally transferred from US-based Merck to Santen.

Core OP 12.2

Core OP 12.4

-0.6

+1.5

+0.1

-1.2

+0.2

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(JPY billions)

1Q FY15 Actual

1Q FY16 Actual

Revenue Revenue Var. (YoY) Operating profit***

U.S. 1.4* 0.4* -70.7% -0.3

Europe 5.3 6.7 +26.7%** 0.7

Asia 6.3 6.0 -4.8% 1.3

China 3.6 3.6 -1.1%**

Total 13.0 13.2 +1.0% 1.7

Overseas revenue / Total revenue 27.2% 26.3% -0.9pt

* Net profit margin (NPM) relating to the US-based Merck product acquisition is treated as revenue in the U.S. **Year-on-year change on a local currency basis: Europe +37.0%, China +17.7% ***Company policy on accounting for profit does not allocate certain SG&A and R&D expenses. NPM is distributed by region

after operationally transferred from US-based Merck to Santen.

Overseas Revenue and Operating Profit

9

Page 11: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

FY2016 Consolidated Forecast ending March 31, 2017 (Revised)

10

Page 12: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

FY2016 Consolidated Forecast (Revised)

11

Forecasts are revised to account for the appreciation of the Japanese yen and the acquisition of InnFocus, Inc. (U.S.) announced in July 2016

Revenue forecast change -4.0 billion yen Currency translation impact causes forecasts to be

adjusted from 204b yen to 200b yen

Core operating profit change -1.9 billion yen No net impact on core OP from change in foreign exchange

rate assumptions Increased cost of 1.9b yen from SG&A, R&D, etc. resulting

from the consolidation of InnFocus

Note: Forecasts are based on current accounting treatment and assumptions about

the acquisition. Santen discloses promptly when significant differences arise.

Page 13: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

(JPY billions) FY15 Actual

FY16

Forecast (Previous)

Impact of fluctuations in

currency

Impact of Acquisition of

InnFocus Forecast (Revised) Var. (YoY)

Revenue 195.3 204.0 -4.0 - 200.0 +2.4% Cost of sales

(% of revenue) -72.8

37.3% -78.0

38.2% +1.5

-

-76.5 38.3%

+5.0% +1.0pt

SG&A expenses (% of revenue)

-59.4 30.4%

-59.5 29.2%

+1.5

-1.0

-59.0 29.5%

-0.7% -0.9pt

R&D expenses (% of revenue)

-20.0 10.2%

-20.5 10.0%

+1.0

-0.9

-20.4 10.2%

+2.1% -0.0pt

Core operating profit (% of revenue)

43.1 22.1%

46.0 22.5%

0.0

-1.9

44.1 22.1%

+2.3% -0.0pt

Non-recurring SG&A expenses - - - -0.6 -0.6 - Amortization on intangible assets associated with products (% of revenue)

-6.2 3.2%

-7.1 3.5%

+0.1

-

-7.0 3.5%

+12.8% +0.3pt

Other revenue Other expenses

45.0 -1.7

- -0.2

- -

- -

- -0.2

- -88.1%

Operating profit (% of revenue)

80.2 41.1%

38.7 19.0%

+0.1

-2.5

36.3 18.1%

-54.7% -22.9pt

Core net profit for the year 29.2 31.8 +0.2 -1.8 30.2 +3.5% Core ROE 12.4% 12.0% - - 11.4% -1.0pt Net profit for the year 53.4 26.9 +0.1 -1.8 25.3 -52.6% ROE 22.6% 10.0% - - 9.5% -13.1pt

Currency rates FY15 Actual FY16 Forecast

(Previous) FY16 Forecast

(Revised) US$ JPY 120.45 JPY 115.00 JPY 105.00 Euro JPY 132.46 JPY 125.00 JPY 115.00 CNY JPY 19.05 JPY 17.50 JPY 15.00

FY2016 P&L Statement Forecast (Revised)

12

Page 14: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

FY2016 Dividend Forecast

13

Page 15: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Dividend for FY2015 and FY2016 Forecast

14

Annual dividend FY2015: JPY 25 per share FY2016 (forecast): JPY 26 per share

FY2014-FY2017 Shareholder return policy Stable and sustained return to shareholders Maintain a sound and flexible financial position to enable product acquisitions and M&A for

future growth Consider share buybacks in a flexible manner Aim to maintain a dividend payout ratio of about 40%

Annual dividend per share (JPY)*

4 8

10 12 13

16 16 16 18

20 20 20 22

25 26

FY 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016e Payout-ratio (%)** 21 56 40 40 43 55 67 36 36 51 51 48 38 ***19 43

Share buy-back (b yen) 3.2 0 2.6 0 0 4.8 0 0 0 0 13.7 0 0 0 -

Total return (%)** 60 56 63 40 43 86 67 36 36 51 134 48 38 19 -

* The company implemented a 5-for-1 stock split on April 1, 2015. Accordingly, the calculations of annual dividend per share have been adjusted in all periods for comparison purposes.

** J-GAAP standards used until FY13, IFRS applied from FY14. ***Removing the related impact of the succession of the company's anti-rheumatic pharmaceutical business, the

payout ratio is 35.5% in FY15.

Page 16: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Reference: 1Q FY2016 Consolidated Results

15

Page 17: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Revenue by Business Segment

16

(JPY billions)

1Q FY16 Actual Japan Overseas Total

Revenue Var. (YoY) Revenue Var. (YoY) Revenue Var. (YoY) Pharmaceuticals 36.1 +5.2% 13.1 +0.8% 49.3 +4.0%

Prescription Pharmaceuticals 33.2 +3.8% 13.1 +0.7% 46.3 +2.9%

Ophthalmic 33.1 +13.1% 12.7 +9.2% 45.7 +12.0%

Others 0.1 +12.2% 0.4 -69.8% 0.6 -62.9%

OTC Pharmaceuticals 2.9 +24.3% 0.0 +37.0% 3.0 +24.4%

Others 0.7 +16.8% 0.0 +220.9% 0.7 +20.9%

Medical devices 0.6 +15.5% 0.0 -54.1% 0.6 +13.9%

Others 0.1 +26.5% 0.0 - 0.1 +72.3%

Total 36.9 +5.4% 13.2 +1.0% 50.0 +4.2%

* Anti-RA business was transferred to AYUMI Pharmaceutical Corporation in August 2015.

Page 18: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Summary of Financial Position

17

Major Changes Current assets: Cash and cash equivalent -25.3 billion yen (Income tax paid) Equity: Foreign currency translation adjustment -4.6 billion yen Current liabilities: Income tax payable -19.0 billion yen, Financial liabilities -4.6 billion yen

Shares issued : End of March 2016: 414,192 thousand → End of June 2016: 414,227 thousand

(JPY billions) As of March 31, 2016 As of June 30, 2016

Actual % of Total Actual % of Total Var. (YoY) Non-current assets 160.7 45.2% 155.7 47.3% -5.0 Current assets 194.7 54.8% 173.1 52.7% -21.6

Cash and cash equivalent 99.8 28.1% 74.5 22.7% -25.3

Total assets 355.4 100.0% 328.8 100.0% -26.6 Total equity 260.0 73.2% 256.3 77.9% -3.8 Non-current liabilities 22.2 6.2% 23.5 7.1% +1.3 Current liabilities 73.2 20.6% 49.0 14.9% -24.2 Total liabilities 95.4 26.8% 72.5 22.1% -22.9 Total equity and liabilities 355.4 100.0% 328.8 100.0% -26.6

Page 19: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Summary of Cash Flows

18

(JPY billions) 1Q FY15

Actual

1Q FY16

Actual Var. (YoY)

Cash flows from operating activities -0.3 -14.3 -13.9

Cash flows from investing activities -2.6 -4.1 -1.6

Cash flows from financial activities -7.6 -4.7 +2.9 Net increase (decrease) in cash and cash equivalents -10.5 -23.0 -12.6 Cash and cash equivalents at the beginning of period 65.9 99.8 +33.9

Effect of exchange rate changes on cash and cash equivalents +0.6 -2.2 -2.8

Cash and cash equivalents at the end of period 56.1 74.5 +18.5

Page 20: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Capital Expenditures / Depreciation & Amortization

19

(JPY billions)

FY15 FY16

1Q Actual Full Year Actual 1Q Actual

Full Year Forecast (Revised)

Capital expenditures 0.8 4.5 1.6 7.1 Depreciation and amortization* 0.7 3.1 0.8 3.5 Amortization on intangible assets associated with products 1.4 6.2 1.6 7.1

Amortization of intangible assets related to Santen’s acquisition of US-based Merck ophthalmic products

1.3 5.2 1.3 5.3

Amortization of intangible assets related to Ikervis 0.1 0.6 0.2 0.7

* Excludes amortization on intangible assets associated with products and long-term advance expense

Page 21: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Reference: FY2016 Consolidated Forecast (Revised)

20

Page 22: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

FY2016 Forecast: Business Segment / Overseas Revenue (Revised)

21

(JPY billions)

FY16 Forecast (Revised) Japan Overseas Total

Revenue Var. (YoY) Revenue Var. (YoY) Revenue Var. (YoY) Pharmaceuticals 145.7 +4.7% 51.1 -4.3% 196.8 +2.2%

Prescription Pharmaceuticals 132.0 +2.9% 51.0 -4.3% 182.9 +0.8%

Ophthalmic 131.3 +5.8% 49.6 +2.4% 180.9 +4.8%

Others 0.6 +4.6% 1.4 -71.5% 2.0 -63.0%

OTC Pharmaceuticals 13.8 +26.0% 0.1 +7.9% 13.8 +25.9%

Others 3.0 +12.1% 0.3 +198.4% 3.2 +17.8%

Medical devices 2.6 +10.9% 0.1 -6.2% 2.6 +10.4%

Others 0.4 +21.2% 0.2 - 0.6 +70.1%

Total 148.7 +4.8% 51.3 -4.0% 200.0 +2.4%

Page 23: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

FY2016 Forecast: Overseas Revenue and Operating Profit (Revised)

22

(JPY billions)

FY15 Actual

FY16 Forecast (Revised)

Revenue Revenue* Var. (YoY) Operating profit**

U.S. 5.3 1.7 -68.1% -3.9 Europe 25.6 28.1 +9.8% 4.6 Asia 22.6 21.4 -5.2% 4.0

China 13.5 11.4 -15.6% Total 53.4 51.3 -4.0% 4.7

Overseas revenue / Total revenue 27.4% 25.7% -1.7pt

* Net profit margin (NPM) relating to the US-based Merck product acquisition is treated as revenue in the U.S. * Company policy on accounting for profit does not allocate certain SG&A and R&D expenses. NPM is distributed

by region after operationally transferred from US-based Merck to Santen.

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23

(JPY billions) FY15 Actual

FY16 Forecast (Revised)

IFRS operating profit 80.2 36.3

Non-core deduction items -37.1 +7.8

Non-recurring SG&A expenses - +0.6 Amortization on intangible assets associated with products +6.2 +7.0

Other revenue -45.0 -

Other expenses +1.7 +0.2

Core operating profit 43.1 44.1

Reconciliation of IFRS to Core OP

Page 25: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

IFRS and Core Comparisons

Use of Core Basis Indicators Core results are now used as financial indicators to better express

underlying business performance by removing certain gains and expenses from IFRS results

Non-recurring items excluded from IFRS to calculate core results: amortization associated with products, other income and expenses, finance income and expenses, etc.

IFRS Core Revenue Revenue

Cost of sales Cost of sales Gross profit Gross profit

SG&A SG&A R&D R&D Amortization on intangible assets associated with products Other income Other expenses

Operating profit Core operating profit Finance income (interest, dividends, forex gains) Finance expenses (interest, forex losses)

Profit before tax Core profit before tax Income tax expenses Income tax expenses

Net profit Core net profit

Excluded from core

Excluded from core

Excluded from core

Excluded from core

Excluded from core

24

Page 26: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Reference: Market Overview of Prescription Ophthalmic in Japan

25

Page 27: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Japan: Trends & Competition in Ophthalmics (1)

26

Cornea / Dry Eye Anti-glaucoma Ophthalmology Total

-Santen: - Anti-Glaucoma : Cosopt, Tapros, Timoptol/XE, Trusopt, Rescula, Tapcom, Detantol - Cornea / Dry Eye : Hyalein, Diquas

Market Size: JPY billions %: Value Share

FY2015 1Q FY2016

YoY Market +7.3% +1.2%

Santen +17.6% +6.7%

Santen’s Share 44.0% 44.9%

FY2015 1Q FY2016

+6.5% +4.0%

+8.4% +2.6%

32.6% 32.3%

FY2015 1Q FY2016

+4.9% -0.8%

+1.4% -2.6%

63.4% 62.8%

Source: ©2016 IMS Health IMS-JPM 2014-16 Santen analysis based on IMS data Reprinted with permission

FY15 347.5

FY15 112.6

FY15 46.4

Others 67.4%

Santen 32.6%

Santen 63.4%

Others 36.6%

Others 56.0%

Santen 44.0%

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Japan: Trends & Competition in Ophthalmics (2)

27

Anti-infection Anti-allergy

-Santen: - Anti-infection: Cravit, Tarivid - Anti-allergy: Alesion, Livostin, Alegysal - Anti-VEGF: Eylea

FY2015 1Q FY2016

YoY Market -2.5% -9.6%

Santen -10.1% -19.4%

Santen’s Share 49.8% 45.5%

FY15 16.4

FY15 35.8

Others 50.2%

Santen 49.8% Others

63.7%

Santen 36.3%

Source: ©2016 IMS Health IMS-JPM 2014-16 Santen analysis based on IMS data Reprinted with permission

Anti-VEGF

FY2015 1Q FY2016

+20.9% -1.3%

+62.7% +22.4%

65.7% 71.2%

FY15 74.5

Others 34.3%

Santen 65.7%

FY2015 1Q FY2016

+5.7% +14.5%

+19.5% +26.6%

36.3% 41.8%

Market Size: JPY billions %: Value Share

Page 29: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Status of Clinical Development 1Q FY2016

Senior Corporate Officer Chief Scientific Officer (CSO) Head of Global Research & Development

Naveed Shams, M.D., Ph.D.

Page 30: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9

Disease Area Project

Mechanism of

Action

Compound /Product Region

Development Stage Changes from Previous

Announcement P1 P2 P3 Filed APV/ Launch

Glaucoma/ Ocular hypertension

DE-111 Prostaglandin F2α derivative/

Beta-adrenergic receptor blocker

Tafluprost and Timolol maleate

KR ★ Launched

Asia

DE-118 Prostaglandin F2α derivative

Tafluprost (single-use type) Asia

DE-085 Prostaglandin F2α derivative Tafluprost CN

DE-117 EP2 receptor agonist Undetermined

US

JP P2b/3

DE-090 Calcium antagonist Lomerizine HCl JP

DE-126 FP/EP3

receptors dual agonist

Sepetaprost US

Status of Main Projects in Clinical Development (1)

29

Global JP (Asia) As of August 2, 2016

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Disease Area Project

Mechanism of

Action

Compound /Product Region

Development Stage Changes from Previous

Announcement P1 P2 P3 Filed APV/ Launch

Kerato-conjunctival disease

Cyclokat Immuno

suppression /Cationic emulsion

Ciclosporin/ Ikervis

EU US KR

Asia

DE-089 P2Y2 receptor agonist

Diquafosol sodium

CN Asia ★ Launched in VN and TH

Retinal/ Uveal disease

DE-109 mTOR inhibitor Sirolimus

EU ★ Withdrew, plan to resubmit

JP US

Asia

DE-120 VEGF/PDGF inhibitor Undetermined US

DE-122 Anti-endoglin antibody Undetermined US P1/2

Allergy Vekacia Immuno

suppression /Cationic emulsion

Ciclosporin EU

Status of Main Projects in Clinical Development (2)

30

Global JP (Asia) As of August 2, 2016

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Forward-Looking Statements

31

Information given in this 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.

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Santen Acquisition of InnFocus, Developer of MicroShunt Glaucoma Implant Device

Akira Kurokawa President & CEO

August 2, 2016

Copyright© 2016 Santen Pharmaceutical Co., Ltd. All rights reserved.

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1

External Environment for Prescription Ophthalmic Pharmaceuticals

Prescription ophthalmic pharmaceuticals

Competition among existing players

Global generic (Gx) pharmaceutical companies enter into ophthalmology

Overlap of adjacent markets (OTC, Device, Vision Care)

Adjacent territory players enter into prescription

ophthalmic pharmaceuticals

(Gx manufacturing)

Government / payer pressure to suppress

medical costs

Need for accountability on cost-effectiveness

Regenerative medicine, artificial vision devices, IT etc. start clinical

trials

Systemic pharmaceutical companies / biotech ventures are expanding into ophthalmology with new compounds

Aging societies

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2

2012

Novagali Pharma acquisition

• Strengthened R&D, including Novasorb® formulation technology

• IKERVIS (now launched in several European countries)

• Supported growth in global business platform

Merck & Co., Inc. ophthalmology

product acquisition

2014

• Acquired product sales: 21.6b yen in FY15

• Reinforced global presence

• Accelerated EU and Asia growth

• Increased profitability • Expanded key

glaucoma franchise

Anti-rheumatic (RA)

pharmaceutical business

divestment

2015

• 45b yen received to support future investment

7% RA 93% Op

100% Ophthalmology

InnFocus acquisition

2016

• Santen to enter high growth glaucoma device area

• USD225m upfront plus milestones

• MicroShunt U.S. launch expected in 2020/2021

• CE marked in Europe • Developing globally including

Asia

Enhancing Pipeline with InnFocus MicroShunt®

Glaucoma Implant Device

Santen Makes Another Strategic Step in Business and R&D Specialization in Ophthalmology

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InnFocus Strategic Value to Santen

InnFocus builds upon the execution of our strategy “To Become a Specialized Pharmaceutical Company

with a Global Presence” To provide glaucoma patients and doctors with new and

innovative treatment options • Enhance customer satisfaction as a specialized company

To strengthen Glaucoma business through synergy • Synergy with existing and developing products, customer relationships

and commercial infrastructure to strengthen our market presence in glaucoma

To add to mid- and long-term growth • Enhance pipeline to create mid- and long-term growth opportunity,

contributing to strategic vision to 2020 and beyond

Medical devices have high probability of development / approval success

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InnFocus, Inc. Acquisition Overview

Company name InnFocus, Inc.

Founded 2004

Headquarters Miami, Florida, U.S.

Lead product MicroShunt glaucoma implant device (U.S. studies ongoing)

Acquisition price USD 225 million plus milestones

Anticipated closing Within Santen’s Q2, ending Sep 30, 2016

Revenue opportunity estimate (annual)

Over USD 200 million

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Designed to avoid stimulation of immune response that leads to stent occlusions and surgical failures

SIBS technology is bioinert Proven effective in TAXUSTM cardiovascular stents at

minimizing occlusions & stent failures

Innovative Bio-Inert Product Material

Designed to address invasiveness of Trabeculectomy

Extremely small micro-tube (twice the size of an eyelash) Minimize incision size and scarring Reduce post surgical complications rates <15 minute implant time

Micro-Invasive Surgical Design

MicroShunt – Designed to Offer Differentiating Features

MicroShunt

Source: J Glaucoma. 2016 Feb;25(2):e58-65.

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MicroShunt Will Allow Santen Broader Coverage of Disease Phases and Enhance Portfolio

Therapy Initiation Disease Progression

+

Prostaglandin Prostaglandin + BB

Combination

Beta Blocker + CAI

Combination

Beta Blocker Carbonic Anhydrase

inhibitor

Santen glaucoma portfolio

MicroShunt

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• Santen is focused on glaucoma, already our largest therapeutic area at 25% of revenue 25%

7%

Products & platform

2.5x

Growing market

• Santen has 7% global share in glaucoma*, room to grow

• Glaucoma business is boosted by acquired MSD products and new business platforms in EMEA** and Asia

• The market is expected to grow substantially

*Santen estimates, **Europe, Middle East and Africa

• Over past five years, sales grew 2.5 times to 55 billion yen in FY15

• Glaucoma is highly profitable

Glaucoma is a Key Growth Driver for Santen

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8 Sources: Market Scope, Santen estimates

Glaucoma Market is Growing

U.S. Demand for Micro-Invasive Glaucoma Surgery (MIGS)

2015 70,000

CAGR >40%

Number of Patients

2025 400,000

48.8 53.0 59.9

Other glaucoma

Primary open-angle

glaucoma

2013 2020

Global Glaucoma Patient Population

70.1

90.6

2015

80.4

U.S. primary open-angle glaucoma 2013 2015 2020 3.3 3.5 3.8

Number of Patients, millions

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MicroShunt is expected to provide an important new option for physicians and patients in the elusive goal of IOP management

Significant opportunity for Santen to enter the high growth glaucoma device segment

Strong synergy with existing portfolio, organization, capabilities and customer base

Key step in the realization of our vision to become a specialty pharmaceutical in ophthalmology

Strategic Acquisition Strengthens Santen’s Position in Ophthalmology

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Appendix

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MicroShunt Technology Can Deliver Consistent and Sustained Gold Standard IOP Lowering

Sources: * Am J Ophthalmol. 2000 Oct;130(4):429-40., **J Glaucoma. 2016 Feb;25(2):e58-65.

Change in IOP with time for MicroShunt implanted with and without phacoemulsification with IOL implantation**

• MicroShunt has the ability to fundamentally transform patient outcomes by delivering gold standard efficacy and addressing the issues limiting widespread surgical use in moderate-severe patients

• Capable of optimizing vision preservation and limiting the progression to blindness*

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Late Stage Clinical Study Underway

Trial No. INN-005 (NCT01881425)

Study Title A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt™ Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma

Study Design Prospective, randomized, single blind (subject), multicenter

Enrollment 857

Country US

Phase Phase 2/3

Indication Primary Open Angle Glaucoma

Primary Endpoint 20% decrease in diurnal intraocular pressure from baseline to 12 months follow-up

Secondary Endpoint Reduction in diurnal intraocular pressure from baseline to 12 months follow-up

Estimated Completion July 2019 (final data collection date for primary outcome measure in July 2018)

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Gold standard glaucoma surgical interventions have seen limited use historically despite their unparalleled ability to deliver sustained target IOP in moderate-severe glaucoma patients and potential to transform visual outcomes

50% of patients undergoing trabeculectomy suffer from serious short and long-term post surgical complications*

30% of trabeculectomies fail within 24 months of surgery*

Glaucoma surgeons spend 10 – 20 hours on post operative patient care due to serious post surgical complications and

current failure rates**

Surgical Failure Rates

Post – Operate Complication Rates

Post Operative Care

Invasiveness of Surgical Procedures

Trabeculectomy is a non-microinvasive surgical technique that requires a larger ocular incision and produces increased levels of

scarring

Challenges Associated with Trabeculectomy

Sources: * Am J Ophthalmol. 2009 Nov;148(5):670-84., ** Market Scope

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14

Forward-Looking Statements

Information given in this 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.

Page 49: Investor Meeting on FY2016 First Quarter Results and ...€¦ · consigned them to US-based Merck until the completion of transfer of the underlying marketing rights. 1Q FY16: 36.9