Kyowa Kirin Co., Ltd. · TSE:4151

Kyowa Kirin — Kyowa Hakko Kirin — FY2013 Earnings Presentation

45 slides from Kyowa Kirin's earnings presentation, Feb 3, 2014

Slide 1: Fiscal 2013 Results Presentation
Fiscal 2013 Results Presentation (Fiscal year to December 31, 2013) February 3, 2014 Kyowa Hakko Kirin Co., Ltd. 1
Slide 2: Agenda
Agenda Business overview President and CEO Nobuo Hanai Financial review Managing Executive Officer Kazuyoshi Tachibana R & D review President and CEO Nobuo Hanai Medium-term business plan review President and CEO Nobuo Hanai Q & A session 2
Slide 3: Forward-looking statements
Forward-looking statements This document contains certain forward-looking statements relating to such items as the company’s (including its domestic and overseas subsidiaries) forecasts, targets and plans. These forward-looking statements are based upon information available to the company at the pr
Slide 5: Fiscal 2013 Highlights
Fiscal 2013 Highlights  NESP® maintained its No 1. position in sales in the Japanese ESA1 market 1Erythropoietin Stimulating Agent  In Europe, Abstral® achieved swift market penetration and expanded sales  Acquired approval for and launched three new pharmaceutical products2 in the Japanese marke
Slide 6: Fiscal 2013: Highlights
Fiscal 2013: Highlights  NESP® maintained its No 1. position in sales in the Japanese ESA* market  In Europe, Abstral® achieved swift market penetration and expanded sales No. 1 in sales in the Top fentanyl brand in Europe Japanese ESA market • Effective frontline anemia treatment • First sublingu
Slide 7: Fiscal 2013: Highlights
Fiscal 2013: Highlights  Acquired approval for and launched three new products for the Japanese market  Began phase III trials of KW-6002 in Europe and the U.S. Also accelerated development of KRN23 Launched three new products Accelerated global including a first-in-class drug deployment KW-0761 1
Slide 8: Fiscal 2013: Highlights
Fiscal 2013: Highlights  Achieved record ordinary income and net income  Overseas subsidiary ProStrakan achieved profitability on a consolidated basis Achieved record high in net Achieved profitability in third income year following acquisition Net income 30.0 25.6 300  Expanded sales, centered o
Slide 10: Summary of FY 2013 results (consolidated)
Summary of FY 2013 results (consolidated) Revenue increased due to strong sales of pharmaceutical products in Japan and ProStrakan’s steady growth as well as the effect of yen weakness. 2013 Rate of (Unit: billion yen) FY2012 FY2013 Change achievement Forecast +7.4 +1.6 Net sales 333.1 340.6 339.0 (
Slide 11: Analysis of YonY profit changes
Summary of full-year consolidated results: Analysis of YonY profit changes FY2013 net income (total): Analysis of YonY changes (¥bn) Pharmaceuticals –¥1.8bn Kyowa Hakko Kirin (non-consol.) +¥0.8bn 32.0 (Introduction cost of Onglyza in 2012 +5.8 ¥3.0bn) 30.0 ProStrakan –¥3.1bn (currency effects –¥2.8
Slide 12: Summary of FY 2013 financial results by segment
Summary of FY 2013 financial results by segment In the Pharmaceuticals business, sales and profit increased due to strong domestic sales and despite a decline in technology licensing income. In the Biochemicals business, sales and profit increased due in part to yen weakness. (Unit: ¥bn) FY2012 FY20
Slide 13: Pharmaceuticals business: Domestic
Pharmaceuticals business: Domestic Domestic sales were impacted by generics and biosimilars but targets were achieved. Product name/ FY2012 (a)* FY2013 (b)* Change (b)- Reason for change Rate of Exports / (a) progress Technology out- (%) ** licensing NESP® 58.1 56.0 -2.0 Impacted by lower shipments
Slide 14: Pharmaceuticals Business: FY2013 results: Analysis of YonY profit changes
Pharmaceuticals Business: FY2013 results: Analysis of YonY profit changes 〔売上⾼〕 Net sales 〔連結営業利益〕 Operating income 〜〜〜〜〜 FY2012 FY 2012 〜〜〜 Domestic sales Gross profits (parent) -2.7 Exports -3 (Parent) SG&A Technology (excl. R&D -2.7 licensing expenses) (parent) Overseas sales R&D expenses (
Slide 15: Bio-Chemicals Business: FY 2013 results: Analysis of YonY profit changes
Bio-Chemicals Business: FY 2013 results: Analysis of YonY profit changes Net sales Operating income 〜〜〜 FY 2012 FY 2012 〜 Healthcare (parent) Gross profits Pharma/ Industrial use (Parent) Overseas SG&A, sales (excl. R&D expenses) Dai Ichi Fine Chemical R&D expenses Other/ Eliminations 〜〜〜 FY 201
Slide 16: FY2014 Forecasts
FY2014 Forecasts FY2012 FY2013 FY2014 Difference (Unit: Billion yen) Results (a) Forecasts (b) (b)-(a) -3.6 Net sales 333.1 340.6 337.0 (- 1.1%) Operating income 52.9 51.7 41.0 -10.7 Operating 15.9% 15.2% 12.2% (-20.8%) margin Ordinary -14.5 49.0 49.5 35.0 income (-29.3%) -10.0 Net income 24.1 30.0
Slide 17: FY2014 forecasts by segment
FY2014 forecasts by segment In the Pharmaceuticals business, we forecast a decline in sales and profits due to the significant impact of drug price revisions. In the Bio-Chemicals business, we forecast an increase in sales and profits due to an increase in sales volumes of core amino acids and other
Slide 18: Pharmaceuticals Business: 2014 outlook
Pharmaceuticals Business: 2014 outlook: Analysis of YonY profit changes Net sales Operating income 〜〜〜〜〜 FY 2013 FY 2013 〜〜〜 Domestic sales (parent) Impact of drug Exports price revisions -3 (Parent) +5 Technology R&D licensing expenses (parent) Overseas sales Other (including ProStrakan) 〜〜
Slide 19: Bio-Chemicals Business: 2014 outlook
Bio-Chemicals Business: 2014 outlook: Analysis of YonY profit changes Net sales Operating income 〜〜〜 FY 2013 〜 FY 2013 Healthcare (parent) Pharma/ Gross profits Industrial use (Parent) SG&A, Overseas (excl. R&D sales expenses) Dai Ichi Fine Chemical R&D expenses Other/ Eliminations 〜 FY 2014 〜 for
Slide 20: Financial management
Financial management The return of profits to shareholders is the top priority. Maximizing corporate value maximizes shareholder value. Shareholder return • We will aim for a stable dividend return with a dividend payout ratio of 40% of profits prior to amortization of goodwill • Regarding the repur
Slide 22: FY2013 Progress in main development pipeline: Domestic
FY2013 Progress in main development pipeline: Domestic Approval and launch of three new drugs including NOURIAST®, a first-in- class drug. Four biopharmaceutical products* in late-stage development. *Development numbers of these four products are underlined below. Product name/development Category n
Slide 23: FY2013 Progress in main development pipeline: Overseas
FY2013 Progress in main development pipeline: Overseas Began global phase III trial for KW-6002. Completed phase I trial for KRN23 and preparing for pediatric trials. Category Development Mechanism of action, etc. Stage number Oncology KW-0761 Anti-CCR4 Phase 3 (In progress) Humanized Antibody CNS K
Slide 24: KHK4563: Update
KHK4563: Update Structure / MoA Anti-IL-5Ra humanized MAb with enhanced ADCC using POTELLIGENT® technology (1) Antibody binding Effecter cell (2) Recognition by the effecter cells (NK, MF, etc) (3) Target cell killing Fc receptor Remarks (2) Development Area: Asia KHK4563 (3) Generic name: Benralizu
Slide 25: KW-6002: Phase 3 Trial design
KW-6002: Phase 3 Trial design KW-6002 began global phase 3 trial under SPA1 agreement with the FDA. Target: Patients with moderate to severe Parkinson's Disease who are being treated with Levodopa and have shown symptoms of wearing-off phenomenon2 40 mg KW-6002 Randomized Estimated enrollment: 609 2
Slide 26: KHK4577: Phase 2 Trial design
KHK4577: Phase 2 Trial design In-house low-molecular weight oral compound. Evaluate the efficacy, safety, and pharmacokinetics of KHK4577 in patients with atopic dermatitis. Target: Patients with moderate to severe atopic dermatitis Randomized KHK4577 Estimated Placebo enrollment: 90 Duration of adm
Slide 27: KW-0761: Global development update
KW-0761: Global development update Increase in KW-0761 indications accelerating value maximization. Indication Country/ Development stage Annual incidence per disease, other region ATL Untreated Japan Filed (Jul 2013) ATL: 1,1001 ATL Relapsed/ U.S. Phase 2 Europe, U.S.: Investigating refractory Euro
Slide 28: FY2014 key achievements
FY2014 key acheivements Domestic • Approval for additional indication for humanized CCR4 monoclonal antibody POTELLIGENT® ・Untreated CCR4-positive adult T-cell leukemia-lymphoma (ATL) ・Relapsed CCR4-positive peripheral T-cell lymphoma (PTCL) ・Relapsed or refractory CCR4-positive cutaneous T-cell lym
Slide 29: Medium-term Business Plan review
Medium-term Business Plan review 29
Slide 30: FY2013-2015 Medium-term business plan progress
FY2013-2015 Medium-term business plan progress Steady progress towards becoming GSP* under three basic strategies. 1. Further strengthen competitiveness in Japan through our category-based strategy Strengthened category-based strategy function: Reorganization of R&D Division Strengthen category prod
Slide 31: Establishment of R&D Division as of April 1, 2014
Establishment of “R&D Division” as of April 1, 2014 Consolidation and reorganization of research and development divisions 【Purpose】 To advance “Category-based Strategy” and enhance productivity of KHK’s R&D activities 【Essential points】 1. Integrate operations of drug discovery research, project ma
Slide 32: Strengthening the Bio-Chemicals business earnings base
Strenthening the Bio-Chemicals business earnings base Stable progress in strengthening our revenue base—a basic strategy of the medium-term business plan. Steady progress with reorganization of production facilities with a future focus. Global high-function amino acid market gradually expanding  M
Slide 33: Medium-term Business Plan – revision of FY2015 guidance
Medium-term Business Plan – revision of FY2015 guidance （At time of Medium-term FY2013 FY2014 FY2015 business plan announcement） (Unit: ¥bn) FY2015 inital results forecasts guidance guidance Net sales 340.6 337.0 355.0 358.0 Operating 51.7 41.0 55.0 60.0 income1 Operating profit margin 15.2% 12.2% 1
Slide 34: Medium-term Business Plan – revision of FY2015 guidance
Medium-term Business Plan – revision of FY2015 guidance FY2015 guidance FY2014 at time of Medium-term (Unit: ¥bn) FY2013 results FY2015 guidance Forecast business plan announcement1 Net sales 340.6 337.0 355.0 358.0 Pharmaceuticals business 261.0 250.0 265.0 270.0 Bio-Chemicals business 82.9 90.0 93
Slide 35: FY2015 guidance: Analysis of factors of increase/decrease
Medium-term Business Plan FY2015 guidance Analysis of factors of increase/decrease Revision of guidance from time of announcement of Medium-term Business Plan. Continued progress of investment in R&D, despite impact of weaker yen. Old guidance 2015 60.0 Key factors ①Bio-Chemicals business +2.0 •Curr
Slide 36: Maximize corporate value and achieve sustainable growth
Maximize corporate value and achieve sustainable growth 36
Slide 37: Maximize corporate value
Maximize corporate value Multi-matrix expansion of antibody-technology based drug discovery of new biopharmaceuticals. In-house Out-licensed development pipeline KW-0761 MEDI-563 KW-3357 SAR252067 KHK4563 Antibody Technology Biopharmaceuticals production technology Co-development ASKP1240 Antibody t
Slide 38: Maximize corporate value: unmet medical needs
Maximize corporate value Utilizing antibody technology and other strengths to address unmet medical needs. Utlizing bio production technologies to contribute to unmet health economics needs. Unmet medical needs Unmet health economics needs Utilizing independently developed For high-cost bio-medicine
Slide 39: Achieve sustainable growth
Achieve sustainable growth Bio-medical products expected to grow beyond FY2016. Number of key bio-medical products Bio-medical product application status/schedule1 (No. of 10 Antibody Protein preparation products products) FY2013 KW-0761 expansion KRN125 application application filed filed FY2014 KW
Slide 40: Create new value
Create new value Creation of new value, backed by experience and proven capabilities in bio- medical research and development. Bio-medical drug discovery Bio-medical manufacturing technology: technology: •POTELLIGENT® technology •More than 200 process •COMPLEGENT® technology research engineers •KM-M
Slide 42: Contact information
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. If you have any inquiries regarding this presentation please call: Corporate Communications Depa
Slide 44: FOREX related
FOREX related Period average rate Average FY2012 FY2013 FY2014 exchange rate ¥/$ ¥80/$ ¥96/$ ¥100/$ ¥/€ ¥103/€ ¥127/€ ¥130/€ ¥/£ ¥127/£ ¥150/£ ¥155/£ FY2013 currency effects (YoY) Segment Currency Net sales Operating income Pharmaceuticals $ +¥2.3bn +1.4bn business € +¥0.2bn +0.2bn £ +¥3.7bn +0.0bn
Slide 45: Development progress with out-licensed compounds
Development progress with out-licensed compounds Phase Name Partner Remarks I II III Cancer Tivozanib AVEO (VEGF receptor inhibitor) (KRN951) Asthma (Anti-IL-5R antibody) BenralizuMab AstraZeneca (KHK4563) (MEDI-563) /MedImmune POTELLIGENT® COPD KRN5500 DARA Peripheral neuropathy RGI2001 REGiMMUNE P

Kyowa Hakko Kirin — FY2013 Earnings Presentation on 6ix

Kyowa Kirin — Kyowa Hakko Kirin — FY2013 Earnings Presentation

Slide 1: Fiscal 2013 Results Presentation

Slide 2: Agenda

Slide 3: Forward-looking statements

Slide 4: Business overview

Slide 5: Fiscal 2013 Highlights

Slide 6: Fiscal 2013: Highlights

Slide 7: Fiscal 2013: Highlights

Slide 8: Fiscal 2013: Highlights

Slide 9: Financial review

Slide 10: Summary of FY 2013 results (consolidated)

Slide 11: Analysis of YonY profit changes

Slide 12: Summary of FY 2013 financial results by segment

Slide 13: Pharmaceuticals business: Domestic

Slide 14: Pharmaceuticals Business: FY2013 results: Analysis of YonY profit changes

Slide 15: Bio-Chemicals Business: FY 2013 results: Analysis of YonY profit changes

Slide 16: FY2014 Forecasts

Slide 17: FY2014 forecasts by segment

Slide 18: Pharmaceuticals Business: 2014 outlook

Slide 19: Bio-Chemicals Business: 2014 outlook

Slide 20: Financial management

Slide 21: R & D review

Slide 22: FY2013 Progress in main development pipeline: Domestic

Slide 23: FY2013 Progress in main development pipeline: Overseas

Slide 24: KHK4563: Update

Slide 25: KW-6002: Phase 3 Trial design

Slide 26: KHK4577: Phase 2 Trial design

Slide 27: KW-0761: Global development update

Slide 28: FY2014 key achievements

Slide 29: Medium-term Business Plan review

Slide 30: FY2013-2015 Medium-term business plan progress

Slide 31: Establishment of R&D Division as of April 1, 2014

Slide 32: Strengthening the Bio-Chemicals business earnings base

Slide 33: Medium-term Business Plan – revision of FY2015 guidance

Slide 34: Medium-term Business Plan – revision of FY2015 guidance

Slide 35: FY2015 guidance: Analysis of factors of increase/decrease

Slide 36: Maximize corporate value and achieve sustainable growth

Slide 37: Maximize corporate value

Slide 38: Maximize corporate value: unmet medical needs

Slide 39: Achieve sustainable growth

Slide 40: Create new value

Slide 41: Q&A

Slide 42: Contact information

Slide 43: APPENDIX

Slide 44: FOREX related

Slide 45: Development progress with out-licensed compounds