Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — Q1 2014 Earnings Presentation
26 slides from Kyowa Kirin's earnings presentation, Apr 24, 2014
Slide 1: Results Presentation Fiscal 2014 First Quarter
Conference call materials Results Presentation Fiscal 2014 First Quarter (January 1, 2014 – March 31, 2014) Kyowa Hakko Kirin Co., Ltd. April 24, 2014
Slide 2: Agenda
Agenda Business overview Kazuyoshi Tachibana, Managing Executive Officer Financial review Kazuyoshi Tachibana, Managing Executive Officer R & D review Yoichi Sato, Managing Executive Officer Vice President, Head of R&D Division 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 4: Business overview
KYOWA KIRIN Business overview ss copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 4
Slide 5: FY2014 Q1 Highlights
FY2014 Q1 Highlights Received approval for additional indications for relapsed or refractory CCR4-positive PTCL1 and CTCL2 for POTELIGEO® (March) NESP® granted orphan drug designation for the treatment of anemia with myelodysplastic syndrome and application filed for approval for manufacture and s
Slide 6: Financial review
KYOWA KIRIN Financial review ss copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 6
Slide 7: Summary of FY2014 Q1 results (consolidated)
Summary of FY2014 Q1 results (consolidated) Compared to FY13 Q1, sales and profits declined due to large decline in licensing revenue Compared to forecast, Q1 started strongly and according to plan Rate of 2014 (Unit: billion yen) FY2013 Q1 FY2014 Q1 Change achievement Forecast of forecast Net sales
Slide 8: Analysis of YonY profit changes
Summary of FY2014 Q1 results (consolidated): Analysis of YonY profit changes Q1 net income: Analysis of YonY changes Pharmaceuticals -¥3.0bn (¥bn) Kyowa Hakko Kirin (parent) -¥4.3bn (return of Bisuflex development and sales rights -¥2.1bn, decline in sales of antiallergic agents, others) ProStrakan
Slide 9: Summary of FY2014 Q1 financial results by segment
Summary of FY2014 Q1 financial results by segment In the Pharmaceuticals business, sales and profits declined due to a YonY decrease in sales of antiallergic drugs as a result of lower amounts of airborne pollen, and a decline in licensing revenue. In the Bio-Chemicals business, sales and profits in
Slide 10: Pharmaceuticals business: Analysis of YonY profit changes
Pharmaceuticals business: FY2014 Q1: Analysis of YonY profit changes Net sales Operating income 〜 〜 〜 〜 〜 FY2013 Q1 Domestic 〜 FY2013 Q1 〜 〜 sales (parent) Exports Gross profits (parent) -3 +5 Technology licensing SG&A (parent) (excl. R&D expenses) Overseas sales (including ProStrakan) R&D expenses
Slide 11: Pharmaceuticals business: Domestic sales of key products
Pharmaceuticals business: Domestic sales of key products Some products were impacted by generics and biosimilars, but sales in the nephrology category exceeded forecasts and overall targets were achieved in the domestic business Product name/ FY2013 FY2014 Change Rate of Exports / Q1 Q1 (b)-(a) Reas
Slide 12: Impact of drug price revision in FY 2014
Pharmaceutical business: Impact of drug price revision in FY 2014 Compared to initial forecast operating income around +¥3bn 経理部に確認 Main reason for lower than expected effect was additional pediatric indication for NESP ® Impact of drug price revision on operating income Products developed under - R
Slide 13: ProStrakan steadily developing as contributor to group profit
Pharmaceuticals business: ProStrakan steadily developing as contributor to group profit Continuing growth trend with strategy that leverages strong marketing ability Achieved steady market penetration with growth drivers Abstral® and Sancuso® 60 20 40 10 20 0 0 2011 2012 2013 2014(予想) (Forecast) 201
Slide 14: Biosimilars development update
Pharmaceuticals business: Biosimilars development update Phase 1 trials for FKB327 progressing steadily in the UK Preparation underway for start of phase I trials for FKB238 within the year Development Reference medical product Stage number Biosimilar FKB327 Adalimumab (humira) Phase１ Biosimilar FKB
Slide 15: Bio-Chemicals business: Analysis of YonY profit changes
Bio-Chemicals business: FY2014 Q1: Analysis of YonY profit changes Net sales Operating income 〜 〜 〜 FY2013 Q1 FY2013 Q1 Healthcare 〜 (KHB*) Gross profits Pharma / industrial use (KHB*) SG&A (excl. R&D Overseas sales expenses) Daiichi Fine Chemical R&D expenses Others/ Eliminations 〜 〜 〜 FY 2014 Q1 F
Slide 16: Bio-Chemicals business: Strengthening of revenue base
Bio-Chemicals business: Strengthening of revenue base Overseas: Early shipments of some amino acids and other products in Asia Japan: Growth in healthcare field due to mail order sales growth Improvement in net sales and operating margin centered on Kyowa Hakko Bio Overseas sales Domestic healthcare
Slide 17: R&D review
KYOWA KIRIN R&D review a copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 17
Slide 18: 2014: Updates in key timeline events
2014: Updates in key timeline events Domestic ☑ Approval for additional indications for humanized CCR4 monoclonal antibody POTELLIGEO® • Untreated CCR4-positive adult T-cell leukemia/lymphoma1 • Relapsed or refractory CCR4-positive peripheral T-cell lymphoma • Relapsed or refractory CCR4-positive cu
Slide 19: Key domestic development updates
Key domestic development updates Approval for additional indications for PTCL/CTCL1 for POTELIGEO® KHK4563 included in global trial conducted by AstraZeneca/MedImmune Product Category name/development Mechanism of action, etc. Stage (timing) / Target number Nephrology NESP® Long-acting ESA2 Applicat
Slide 20: NESP: Application for indication of anemia with MDS
NESP®: Application for manufacture and sales for indication of anemia with MDS1 First product designation for ESA2 in Japan Market scale. Standard treatment No. of patients: The treatment targets a segment of the estimated approx. 11,0003 MDS1 patients in Japan. Current treatment: Patients for whom
Slide 21: Global development update (1)
Global development update (1) KW-0761 Indication Country/ Development stage Annual incidence per disease, other region ATL Untreated Japan Preparing for filing Japan: approx. 1,1001 patients ATL Relapsed/ U.S. Phase 2 Europe, U.S.: Investigating refractory Europe Others PTCL Relapsed/ Japan Approval
Slide 22: Global development update (2)
Global development update (2) KW-6002 Indication Country/ Development Annual incidence per disease, other region stage Parkinson’s disease U.S. Filed U.S.: More than 570,0001 patients treated (April 2007) Parkinson’s disease U.S. Phase３ Special Protocol Assessment with FDA Europe Others KRN23 Indica
Slide 23: Group mission and 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 24: Appendix
KYOWA KIRIN APPENDIX copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved a4
Slide 25: Development progress with outlicensed compounds
Development progress with outlicensed 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 Ph
Slide 26: FOREX related
FOREX related Period average rate Average FY2013 FY2014 Change 2014 exchange rate Q1 results Q1 results Full-year forecast ¥/$ ¥89 ¥103 +¥14 ¥100 ¥/€ ¥118 ¥141 +¥23 ¥130 ¥/£ ¥141 ¥171 +¥30 ¥155 FY2014 Q1 currency effects (YoY) Segment Currency Net sales Operating income $ +¥0.3bn +¥0.1bn Pharmaceuti