Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Kyowa Hakko Kirin — Q1 2015 Earnings Presentation
27 slides from Kyowa Kirin's earnings presentation, Apr 28, 2015
Slide 1: Results Presentation Fiscal 2015 First Quarter
Conference call materials Results Presentation Fiscal 2015 First Quarter (January 1, 2015 – March 31, 2015) Kyowa Hakko Kirin Co., Ltd. April 28, 2015
Slide 2: Agenda
Agenda Financial review Kazuyoshi Tachibana, Managing Executive Officer R & D review Yoichi Sato, Sato Managing Executive Officer, 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 h items it as the th companyʼs ʼ (including (i l di it its d domestic ti and d overseas subsidiaries) forecasts, targets and plans. These forward-looking statements are based upon information availa
Slide 4: FY2015 Q1 Highlights
KYOWA KIRIN FY2015 Ql Highlights copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 4
Slide 5: FY2015 Q1 Highlights
FY2015 Q1 Highlights In Q1 of the final year of the medium-term business plan, sales increased and profits declined in the Pharmaceuticals business, while sales and profits declined in the Bio-Chemicals business Made steady progress with FY2015 H1 plan on a consolidated basis In the Pharmaceutical
Slide 6: Financial review
KYOWA KIRIN Financial review ss copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 6
Slide 7: Summary of 2015 Q1 results YoY
Summary of 2015 Q1 results YoY Performance was steady due to the effect of the consolidation of Archimedes, the growth of domestic and new products, and other factors. However, while sales increased, profit declined due to an increase in development p p costs of late-stage g development p products,
Slide 8: Analysis of YoY profit changes
Summary of FY2015 Q1 consolidated results: Analysis of YoY profit changes (¥bn) Q1 net income: Analysis of YoY changes 100 10 Pharmaceuticals +¥1.5bn Kyowa Hakko Kirin (parent) -¥0.8bn ¥0 8bn (impact of drug price revision, etc.) ProStrakan +¥2.1bn (Archimedes, currency effects, etc.) Bio-Chemicals
Slide 9: Summary of FY2015 Q1 financial results by segment
Summary of FY2015 Q1 financial results by segment In the Pharmaceuticals business, sales increased due to growth in new products* and other factors, but profit declined due to an increase in R&D expenses In the Bio Bio-Chemicals Chemicals business, sales and profits declined due to a decrease in shi
Slide 10: Pharmaceuticals business: Analysis of YoY profit changes
Pharmaceuticals business: FY2015 Q1: Analysis of YoY profit changes Net sales Operating income FY2014 Q1 results lt 63 1 63.1 FY2014 Q1 results 94 9.4 Domestic sales (parent) +1.0 Gross profits +1.5 Technology licensing (parent) -0.5 G&A ((excl. R&D expenses) 14 -1.4 Overseas sales (including +4.0 P
Slide 11: Pharmaceuticals business: Domestic sales of key products
Pharmaceuticals business: Domestic sales of key products While sales were affected by drug price revisions in the previous year and the market penetration of generics, sales increased year on year as a result of the market penetration of new products and other factors Product name, FY2014 FY2015 FY2
Slide 12: Bio-Chemicals business: Analysis of YoY profit changes
Bio-Chemicals business: FY2015 Q1: Analysis of YoY profit changes Net sales Operating income FY2014 Q1 FY2014 Q1 23.5 3.0 Healthcare (parent) -0 Gross profits Pharma/ industrial -1.0 use (parent) -1.0 SG&A (excl. R&D O Overseas sales l expenses) -0.4 04 -0.6 Daiichi Fine Chemical R&D expenses -0 -0
Slide 13: R & D review
KYOWA KIRIN R & D review ( copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 13
Slide 14: Key development events (FY2015)
Key development events (FY2015) Domestic: iti ti off Ph ☑Initiation ☑I Phase 2 ttrials i l off RTA 402 ttargeting ti chronic h i kid kidney di disease with ith type-2 diabetes (March) □Initiation of Phase 1 trials of Nivolumab (ONO PHARMACEUTICAL CO., LTD/Bristol-Myers Squibb) in combination with KW
Slide 15: Global development update (1) KW-0761 (hematological cancer)
Global development update (1) KW-0761 (hematological cancer) Development stage Country/ (Scheduled trialcompletion date) Estimated Indication enrollment region Phase 2 Phase 3 Application Approval Untreated Japan 2014/122 ATL Relapsed/ Japan 2012/32 refractory US E U.S., Europe, others th 1 (2015/8)
Slide 16: Global development update (2) KW-0761 (solid tumor)
Global development update (2) KW-0761 (solid tumor) Development stage Country/ Combination (Scheduled trial completion date) Estimated Indication Partner region Drug Phase 1 enrollment MEDI4736 U.S. (2016/6) AstraZeneca 1081 or Tremelimumab To be PF-05082566 To be determined Pfizer ー Solid determine
Slide 17: Global development update (3) KW-6002 Parkinson's
Global development update (3) KW-6002 Development stage Country/ (Scheduled trial completion date) Estimated Indication region enrollment Phase 2 Phase 3 Application Approval Japan 2013/31 Parkinson’s disease North America, Europe, (2016/2) 6094 others Estimated no. of patients Japan: approx. 140,00
Slide 18: Global development update (4) KRN23
Global development update (4) KRN23 Development stage Country/ (Scheduled completion date of trial) Partner Estimated Indication region enrollment Phase 1 Phase 2 Pediatric U.S., Europe (2016/5) 303 Ultragenyx XLH U.S. (2016/9) Pharmaceutical 254 Adult (U.S., Europe) Japan, Korea (not 155 disclosed)
Slide 19: Biosimilar pharmaceutical products development update
Biosimilar pharmaceutical products development update Reference bio medical product Development stage Development Country / code Generic name Brand name region Phase 1 Phase 2 Phase 3 1 FKB327 Adalimumab HUMIRA U.S., others FKB238 Bevacizumab Avastin United Kingdom Determined target Not disclosed No
Slide 20: 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 t h l i technologies. If you have any inquiries regarding this presentation please call: Corporate Communicati
Slide 21: List of acronyms
List of acronyms APIs Active Pharmaceutical Ingredients ATL Adult T-cell Leukemia/Lymphoma CCR4 Chemokine ( C-C motif ) Receptor 4 CTCL Cutaneous T-Cell Lymphoma CTLA-4 Cytotoxic T-Lymphocyte-Associated protein 4 G CS G-CSF G Granulocyte - Colony C S Stimulating Factor MDS Myelodysplastic Syndrome M
Slide 22: APPENDIX
KYOWA KIRIN APPENDIX —kk{&<<—*—CCi—iSe copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 22
Slide 23: Appendix: FOREX related
Appendix: FOREX related Period average rate Average g exchange g FY2014 Q Q1 2015 Q Q1 Change g FY2015 rate Results Results Forecast ¥/$ ¥103 ¥119 +¥16 ¥109 ¥/€ ¥141 ¥138 -¥3 ¥139 ¥/£ ¥171 ¥183 +¥12 ¥178 FY2015 Q1 currency effects (YoY) Segment g Currency y Net sales Operating p g income Pharmaceuti
Slide 24: Development progress with outlicensed compounds
Development progress with outlicensed compounds Phase Name Partner Remarks I II III Cancer Tivozanib AVEO ((VEGF receptor p inhibitor)) (KRN951) Asthma (Anti-IL-5R (A ti IL 5R antibody) tib d ) Benralizumab AstraZeneca (KHK4563) (MEDI-563) /MedImmune POTELLIGENT® COPD KRN5500 DARA Peripheral neuropa
Slide 25: Appendix: Key antibody targets in cancer immunotherapy
Appendix：Key antibody targets in cancer immunotherapy PD-L1 25
Slide 26: Topic: Completion of Kyowa Hakko Bio plant in Thailand
Topic: Completion of Kyowa Hakko Bio plant in Thailand High-value-added amino acids market: pharmaceuticals, medical and healthcare High global growth expected to continue, primarily overseas High ５万トン超 Rapid market expansion in near future associated with, in particular, population increase in As
Slide 27: Q & A session
KYOWA KIRIN Q & Asession a copyright© 2008 Kyowa Hakko Kirin Co.,Ltd. All Rights Reserved 27