New Medium-term Management Plan Co-Creation April, 2017 March, 2022 Create innovative Drugs, Value, and Future with all efforts

Transcription

1 New Medium-term Management Plan Co-Creation April, 2017 March, 2022 Create innovative Drugs, Value, and Future with all efforts

2 Medium-term Management Plan: Co-Creation Five-year plan aiming for a stable growth in the future during drastic changes in the business environment. External factors Internal factors Opportunity Diversifying medical needs Emergence of Unmet Medical Needs (UMN) Support policy of new drug discovery by AMED Six new candidates after PIII Establishment of our presence in urology, renal and dialysis areas Issue/Task Structural change in domestic and global pharmaceutical markets Depletion of new drug seeds Increase in R&D risks Overcoming silodosin (Urief R ) substance patent expiration Productivity improvement on drug discovery research 1

3 Co-Creation Targets for FY2021 (the final year) Consolidated net sales Over 73.0 billion Non-consolidated net sales Pharmaceuticals *1 Therapeutic and care foods Others *2 Operating income Over 61.0 billion Over 50.5 billion Over 4.5 billion Over 6.0 billion Over 6.5 billion R&D expenses Over 13.0 billion *1: Including API and bulk export *2: Supply to domestic sales partners + revenue from technical fees (contact fees from out-licensing of R&D themes, milestone income, and running royalties) 2

4 Basic policy for Co-Creation Management Vision We aim to be an R&D-oriented pharmaceutical company that contributes to the health of people around the world through innovative medical pharmaceutical products. I. Strengthening of drug discovery research II. Expansion of product portfolios III. Maximize domestic sales of medical drugs IV. Construction of stable earnings base overseas 3

5 I. Strengthening of drug discovery research Drug Discovery with Highly original & Competitive advantages Urology, Renal & Dialysis areas Unmet Medical Needs Drug design Screening Structural biology Protein science Computational chemistry (in silico) Throughput Precision Integration of state of the art technology Open innovation Deepening specialization 4

6 Launch & Approval Introductory candidate group II. Expansion of product portfolios Strengthening of drug discovery R&D systems Promotion of R&D projects In-licensing according to therapeutic area strategies Target by FY2021/E (Final Year of the Mid-term plan) Urology, renal & dialysis areas UMN KRP-114V JR-131 MR13A9 NDA in progress NDA in preparation PIII PII PI/PII PI Present AJG511 (ulcerative colitis) GLUBES OD Tab. KRP-114V (overactive bladder) JR-131 (renal anemia) KPS-0373 (spinocerebellar degeneration) AJM300 (ulcerative colitis) MR13A9 (pruritus in dialysis patients) KLH-2109 (endometriosis, uterine fibroids) YS110 (malignant mesothelioma) KDT-3594 (Parkinson's disease) Clinical Trial Stage (including NDA) KPS-0373 AJG511 AJM300 GLUBES OD Tab. YS110 KLH-2109 KDT-3594 Aflibercept BS (age-related macular degeneration) PRX 302 (benign prostatic hyperplasia) New drug discovery candidate group 5

7 III. Maximize domestic sales of medical drugs Strategic allocation of sales resources Establishment of presence in priority areas Dysuria with BPH Treatment drug Urief Existing products Urology Establishment of a top brand for the treatment of benign prostatic hyperplasia Candidates to be launched during the Medium-term plan Overactive bladder treatment drug KRP-114V Hyperphosphatemia treatment drug P-TOL Renal anemia treatment drug Epoetin Alfa BS Renal & Dialysis Market expansion by demonstration of the synergized effects of both drugs Pruritus treatment drug for dialysis patients MR13A9 Renal anemia treatment drug JR-131 Diabetes treatment drug GLUBES Diabetes Diabetes treatment drug GLUFAST UMN Spinocerebellar degeneration treatment drug KPS-0373 Ulcerative colitis treatment drug AJG511 AJM300 6

8 IV. Construction of stable earnings base abroad Out-licensing of new drug candidates Construction of post-silodosin foundation GnRH antagonist KLH-2109 Expected indications: Endometriosis, uterine fibroids Out-licensing to ObsEva (Switzerland) (Global development code: OBE2109) Clinical trials are ongoing in Europe and the United States. Late phase II clinical trial with endometriosis as an indication Phase III clinical trial with uterine fibroid as an indication 7

9 Performance outlook (consolidated) Sales ( billion) 80 Performance image of sales Patent expiration of silodosin New domestic product group Existing products/businesses 15 Operating profits ( billion) Performance image of 20 operating profits 5 0 FY2016 Performance FY2017 FY2018 FY2019 FY2020 FY

10 Shareholder return FY2011 FY2012 FY2013 FY2014 FY2015 FY2016 FY2017 Dividend per share (Forecast) Acquisition of treasury stocks (No. of shares acquired) 4.3billion (2.8million shares) 7.9billion (2.54million shares) 1.6billion (0.61million shares) Retirement of treasury stocks (No. of retired shares) 5.4bilion (2.6million shares) 9

11 FYI: Business performance of PROGRESS 3 in the previous Medium-term plan New product launches, advancement through development stages, in- and out-licensing FY2015 FY2016 FY2017 Launch of Savene R Introduction of AJG511 & AJM300 Launch of Salagen R granule Launch of Urief R OD Tab. Launch of P-TOL R Introduction of MR13A9 Application for approval of AJG511 applied Application for approval of GLUBES R OD Tab. Launch of GLUFAST R OD tab. Start of PI trials for KDT-3594 Start of PIIb trials for KLH-2109 Introduction of KRP-114V Out licensing of KLH-2109 Start of PI/II trials for YS110 Start of PIII trials for JR-131 Start of additional PIII trials for KPS

12 FYI: Financial performance of PROGRESS 3 in the previous Medium-term plan PROGRESS 3 Target Performance in Final FY (ended in March 2017) Consolidated net sales 70.5billion 71.7billion Non-consolidated net sales 61.0billion 61.4billion Pharmaceuticals *1 47.3billion 51.0billion Therapeutic and care foods 4.3billion 3.8billion Others *2 9.4billion 6.5billion Operating income 9.5billion 8.4billion *1: Including API and bulk export *2: Supply to domestic sales partners + revenue from technical fees (contact fees from out-licensing of R&D themes, milestone income, and running royalties) 11

13 The outlook described in this material is based on the analysis of existing information and various trends as of May 2017 by Kissei Pharmaceutical Co. Ltd. Actual results may differ from the forecasts owing to business risks and uncertainties.