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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
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.
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
1Q FY2016 Financial Results ended June 30, 2016
3
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
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
(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
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
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
(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
FY2016 Consolidated Forecast ending March 31, 2017 (Revised)
10
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.
(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
FY2016 Dividend Forecast
13
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.
Reference: 1Q FY2016 Consolidated Results
15
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.
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
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
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
Reference: FY2016 Consolidated Forecast (Revised)
20
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%
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.
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
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
Reference: Market Overview of Prescription Ophthalmic in Japan
25
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%
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
Status of Clinical Development 1Q FY2016
Senior Corporate Officer Chief Scientific Officer (CSO) Head of Global Research & Development
Naveed Shams, M.D., Ph.D.
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
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
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.
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.
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
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
3
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
4
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
5
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.
6
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
7
• 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
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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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.