2013 Expanding Leading-edge Innovations
201220133 1 2012 3,4770.8% 25022.8% 10016.4% 2014 20138
1
2013 2010 2005 2007 > > > 5 2008 8.4% 2
2022 1. 2. 2017 2017 > > > 50.0% 2012 38.3% > > BBI > 3 3
4 2013 2012.7 2012.12 2012.4 LD/HD24 ARB HD 10mg 20124 BBI 20129 BBI CEO R&D 2012.9 20112 2012910 EMA20134 20136 2 2013.2 201320132017 P.8
0.8%3,477 22.8% 25016.4%100 4,000 3,000 3,795 3,504 3,477 2,963 2,640 1,600 1,522 50 1,302 1,331 40 1,200 40.1 37.2 38.3 800 600 564 780 599 603 2,000 1,000 800 400 221 8.4 17.9 530 30 20 10 400 200 420 356 312 310 204 250 0 08 09 10 11 12 0 08 0 09 10 11 12 0 08 09 10 11 12 250 8.0 800 200 150 100 200 210 168 86 100 6.0 4.0 6.2 5.1 6.3 4.1 5.0 2.8 2.7 3.0 600 400 528 514 682 569 598 50 2.0 1.5 1.7 200 0 08 09 10 11 12 0 08 09 10 11 12 0 08 09 10 11 12 20 100.0 18.0 18.0 18.0 18.0 18.0 82.9 80.0 15 71.2 60.0 10 35.8 34.1 42.6 40.0 5 20.0 100 80 60 40 20 89.1 87.9 85.7 80.5 80.3 12,000 8,000 4,000 1.0 10,462.3 11,040.4 9,684.3 10,314.0 0.8 8,616.6 7,615.1 7,488 7,628 0.6 0.5 0.5 6,296 4,739 0.4 0.3 0.2 0.1 0.2 0 08 09 10 11 12 0 0 08 09 10 11 12 0 08 09 10 11 12 0 EBITDAEarnings Before Interest, Taxes, Depreciation and Amortization 2ROE 3ROA 5
Expanding Leading-edge dge Innovations dg 1. 2. 3. 4. 5. 6. 7. 20122012412013331 1615 201220133 331 6
7 2013 1 2 4 Contents 14 23 24 28 30 22 49 31 65 BBI608BBI 503 8 2013 32 CSR ISO26000 32 33 34 35 36 39 40 41 ISO26000 43 48
: 8
9 Q.1 BBI 2
Q.2 21 220136 MR MR20121270 410MR MR2013 Q.3 BBI608BBI503 BBI608 201312015 20133 2016 WT2725 4869WT1 BBI608BBI503 10
Q.4 BBI608 201212 2013CNS CNS MRe- 11
Q.5 POCProof of Concept BBI BBICEOR&D 2017101 PC 20178 2010 20133iPS Global Oncology LGLead GenerationLOLead Optimization 12
Q.6 2014 Q.7 CSR21 2QOL 2 Q.8 13
14 2 2012 BBI
20134 LG 1 LO 2 1 LGLead Generation 2 LOLead Optimization BBI 100 2012950 BBICEO 4 20124CSOChief Scientific OfficerR&D GBSCGlobal Business Strategy Committee GRDC Global R&D Committee 20134 GCD Global Clinical Development Head of GCD Head of GCD Global Oncology 15
16 16 16 16 16 16 16 16 16 16 16 16 16 16 16 16 16 16 POC POC SB623 BBI BBI608BBI503 WT2725 POCProof of Concept 201710 1POC 20178 NDDC DSKiPS ips ips
inips 20129 2 BBI 20129 COPDSUN-101 20133 ips ips 20133 EPI-743EPI-589 CEO 201241 160mg 2 20136FDA 17
20129 EMA 20138 DSP-2230 Nav1.7Nav1.8 2012 ADHDSEP- 225289SEP- 363856 TBial FDA 11 / SB623 / BBI2 BBI608BBI503 BBI BBI608 20152016 / 2012 102012 Top Ten Promising Late Stage Cancer Drugs Fierce Biotech2012 10 BBI503 2017 WT4869WT2725 WT1 18
WT1T CTLWT1 CTL WT4869 MDS/ DSP-3025 Toll-like receptor 7TLR7 AstraZeneca AstraZeneca4 WT2725 201212 20132 20127 COPDSUN-101 DSP-3025 SUN-101 1 6g20131 IBSDSP- 6952Intercept NASHDSP-1747 DSP-1747 PBC DSP-1747 InterceptINT-747 FXR Farnesoid Xreceptor NASH Intercept PBCNASH / NASH SUN-101glycopyrrolate eflow SUN-101 LAMA COPD 19
20
21
22 4 GMP FDA EMATGA GMP ICH EU RABS 4 GMP 201210 2014
マーケティング 国内医薬品市場では 成長品目へのリソース集中による売上の拡大 北米市場では ラツーダ の製品価値最大化に 注力しています 基本方針 北米事業では ラツーダ の利益最大化を最優先しつ 当社では 第三期中期経営計画の基本方針として 強 つ サノビオン ファーマシューティカルズ インク 以下 サ 固な国内収益基盤の確立 海外事業の収益最大化とさ ノビオン社 の既存製品販売体制の最適化をはじめとし らなる事業拡大 などを掲げています た経営効率のさらなる向上を推進しています 国内医薬品事業では 成長品目での売上拡大に向け 中国事業では メペム メロペン をはじめとした既 戦略品である アイミクス アバプロ ロナセン トレ 存製品の販売拡大および新製品の投入により 事業規模 リーフ や 新製品である メトグルコ シュアポスト パ と収益の最大化を図っています キシルCR などへ 営業資源を集中しています エリア別マーケティング体制 2013 年 3 月 31 日現在 中国 MR 数 米国 MR 数 3,072億円 経営効率化のさらなる推進 日本 MR 数 1,410 名 医薬品事業 売上高目標 地域別 3,101億円 ラツーダ の利益最大化 350 名 既存製品の利益拡大 新製品の投入 830 名 成長品目へのリソース集中 3,256 億円 海外その他 中国 北米 日本 2011 2012 2013 年度 予想 MR 医薬情報担当者 アニュアルレポート 2013 23
1,745 MR 1,410 2012 2012 100 2,000 1,500 1,000 500 0 1,799 1,745 1,737 11 12 13 2013CNS 2012 150 100 50 20 117 121 107 107 98 130 55 53 70 92 0 12 13 11 12 13 11 12 13 11 12 13 24
25 MR e- 2012 20126 CR CR SSRI 2012 9.2%10731.8%70 201313092 ACE ARB 24 ARB AVAPRO APROVEL -2-2 11
201212 ARB 2012201212 208.9% 117201355 121 20105 20115 2012 54.4%1202013 152 20124 2013 2 1 20105 CR SSRI 1999 40 20126 SU 2 A1c 20115 26
27 2012 12.1%112.3% 468.7%99 20131350105 2012 8.1%142 B B Gene Activation technology - 240 CTH
1,158 MR 830 2012 202 161134.9% 134.5%2013 20136 1,500 1,000 500 0 1,084 1,158 1,258 11 12 13 20137 20139CM 20141Q1-3 201370% 350 2012 561448 6.3%6.4% 20132014 MR 2012 2013 2012 MR 28
20128 Inhalation Solution 2012317 253 2011 20122419 11 1 20127 201254 201325 COPD 2012160127 26.0% 25.3% SUN-101COPD 20137 MR HFA COPD 29
MR 76 350 2012 20133MR35030 120 105 2013 80 65 76 38.2%105 40 0 11 12 13 20128 13 20135 E1 2012 4 20122011 / 30
DSP DS DS POCTPoint of Care TestingCa ESiPS Companion Diagnostics SS POCT 31
CSR CSR CSR ISO26000 ISO26000 201011 7 CSR http://www.ds-pharma.co.jp/csr/index.html 32
ISO26000 ISO26000 P.43 1 2 3 4 5 6 7 8 1 2 3 4 5 1 2 3 4 1 2 3 4 5 1 2 3 4 5 6 7 1 2 3 4 5 6 7 2 4 5 3 P.34, 35, 4 P.40 5 6 P.36 2 1 P.40 3 P.35, 40. P.34, 35, P.39 P.34, 39 P.41 33
Good Clinical Practice:GCP 2012DVD 34
200920124 38% 20121 2012 40 OJTOn-the-Job Training OffJTOff-the-Job Training OJTOffJT 38% 19% 19% 9% 9% 6% 200920124 35
OUTPUT OUTPUT O INPUT 20052008 3 36
20122014 2012 3 2012 1. PRTR 1.2-69%2010 2. 1 2012CO2 2006 CO2 1 2012 CO22006 97.9% 108% CO2 CO2 2 2 3. % % 1%2012 0.1% 41 411 1.8% 4. 5. 2 20133 6. 7. 8. 37
CO2 CO2 2012 CO2 2012 56% CO2 CO2 3R 201210,314t 21% 7,628t 21% 14.9t18% 0.1%1% 1% 201241 1 1.8% 0 100 80 60 40 20 09 11 10 12 08 07 CO2 0 0 0.4 0.6 0.8 1.0 0.2 12,000 10,000 8,000 6,000 4,000 2,000 09 10 12 11 08 38
TDnet ISO27001 2012 2011119 2012314 201110 20134 2012 20138 39
2012 60,000 DI-SaGaS FAQ QA MR MR MR MR Shink MR ShinkShink SafetyThink MR e- MR MR MR Shink 201260,000 30.1% 19.6% 19.0% 11.1% 8.3% 8.6% 2.7% 40
20125 NPO MNMJ201210 2013 2010750 29 8 20133 450 TABLE FOR TWO 201210 TABLE FOR TWO 120 TABLE FOR TWO International 1 41
20121178 5 201210261119 201151 201241 SUKOYAKA SUKOYAKA 20116 20121122 261,800 42
50.22% 18 1 201215 35 1 201214 2 201223 1 201212 43
35 2012 25290 2012 31 36 2012 2 GCC 44
2012 BCP IT Act Plan Do Check 45
201270 2012 20 2013 3 IR 24 13 2012 2012511 46
201210 URL: http://www.ds-pharma.co.jp/ir/ 2 19684 20028 20052 20116 20116 20136 47
2013621 DSP& Vice Chair, Executive Vice President and Chief Financial Officer Executive Vice President Head of Global Clinical Development for DSP Group IT Executive Vice President and Chief Medical Officer Antony Loebel BBI President, Chief Executive Officer and Chief Medical Officer Head of Global Oncology for DSP Group Chiang J. Li 48
Contents 11 50 52 60 62 63 64 49
11 201320123 347,724 350,396 379,513 296,262 264,037 133,125 130,243 152,226 53,015 22,051 38.3% 37.2% 40.1% 17.9% 8.4% 101,686 98,857 110,030 112,263 103,741 220,994 231,137 238,531 148,374 129,130 25,044 20,402 30,952 35,625 31,166 18,158 16,328 25,050 31,423 32,168 10,044 8,630 16,796 20,958 19,988 37,174 2,396 (12,066) 27,148 333,439 334,251 333,000 287,555 263,540 69,862 66,697 69,794 74,084 69,105 607,219 559,410 589,868 626,743 391,295 124,831 105,966 157,204 265,000 53,350 133,140 134,217 108,681 18,260 13,449 349,248 319,227 323,983 343,483 324,496 59,844 56,891 68,160 51,371 52,819 12,384 8,742 8,663 6,471 10,569 35,085 40,232 44,628 18,650 11,455 60,333 59,880 77,971 56,448 41,970 25.28 21.72 42.27 52.75 50.30 879.03 803.47 815.44 864.51 816.49 18.00 18.00 18.00 18.00 18.00 7.2% 5.8% 8.2% 12.0% 11.8% 3.0% 2.7% 5.0% 6.3% 6.2% 1.7% 1.5% 2.8% 4.1% 5.1% 57.5% 57.1% 54.9% 54.8% 82.9% 50
263,993 261,213 245,784 175,088 171,672 172,554 (0.8%) $3,699,191 24,521 22,032 9,696 3,820 3,630 3,990 2.2% 1,416,223 9.3% 8.4% 3.9% 2.2% 2.1% 2.3% 99,385 99,346 130,437 111,099 110,013 108,046 2.9% 1,081,765 124,794 116,312 86,461 52,404 51,546 51,240 (4.4%) 2,351,000 39,814 45,555 28,886 11,585 10,113 13,268 22.8% 266,426 41,457 38,415 25,687 11,686 13,836 12,718 11.2% 193,170 25,592 22,605 15,377 6,924 7,968 6,364 16.4% 106,851 1,451.5% 395,468 251,063 234,313 249,733 131,176 118,562 116,241 (0.2%) 3,547,223 70,280 65,241 68,336 32,611 34,473 35,374 4.7% 743,213 399,791 382,535 392,966 201,431 193,238 187,416 8.5% 6,459,777 67,915 56,039 80,071 49,196 45,927 60,727 17.8% 1,327,990 13,598 20,484 24,262 16,802 16,258 9,248 (0.8%) 1,416,383 318,278 306,012 288,633 135,433 130,268 116,661 9.4% 3,715,404 47,266 40,870 29,636 17,444 15,929 15,218 5.2% 636,638 15,491 9,543 6,616 3,064 4,294 6,532 41.7% 131,745 11,870 12,008 8,901 5,233 5,821 5,316 (12.8%) 373,245 48,802 54,875 36,179 16,446 16,040 18,254 0.8% 641,840 64.39 56.86 54.57 41.76 48.05 38.02 16.4% $0.27 800.63 767.52 723.63 815.76 784.24 702.09 9.4% 9.35 18.00 14.00 12.00 10.00 10.00 10.00 0.0% 0.19 15.1% 17.4% 11.8% 6.6% 5.9% 7.7% 8.2% 7.6% 7.3% 5.2% 6.5% 5.5% 6.5% 5.8% 5.2% 3.5% 4.2% 3.4% 79.6% 79.8% 73.2% 66.8% 67.1% 61.9% 51
20133 201212 201212 20129 20124 BBI 9 9 SRD20131 100% 20133 270.8%3,477 282.91,017 1.029.2 552.2 2,460 2,000 1,000 0 4,000 3,000 2,640 2,963 09 10 3,795 11 3,504 12 3,477 13 52
101 4.42,210 305.2598 1317.5% 1,612 4622.8 250 69 48 11 20133 1416.4100 300 200 100 0 400 312 356 09 10 310 11 204 12 250 13 400 200 0 700 600 500 300 100 528 514 09 10 682 11 569 12 598 13 88% 50% 33% 2 3% 12% 150 200 100 50 0 250 200 210 09 10 168 11 86 12 100 13 20133 53
1,745543.0 588.7%606 74 6.8%1,158 150 409 11 16.8%769 89.7%18 59 39.1%9327 38.1%43 20.5%405 25.2%30 17 31.8%7020105 4254.4%120 201212 420 6819 161 92134.5% 27448 81 253 292 360 195 212 142 155 120 78 117 107 107 98 103 122 99 91 70 53 58 66 46 45 31 33 31 32 26 36 20 11 13 7 1 54
62 119 18 12 8 8 7,500 5,000 6,267 5,899 6,072 5,594 3,913 448 421 253 334 161 69 127 102 31 28 19 51 4 63 55 4786,072 BBISRD 83,334 BBISRD 455 2,039 BBI 1782,580 3003,492 57.5% 2,500 0 4,000 09 10 3,000 2,000 1,000 0 3,245 11 12 13 82.9 3,435 3,492 3,240 3,192 54.8 09 10 54.9 11 57.1 12 57.5 13 100.0 75.0 50.0 25.0 0 55
499484 BBISRD 550 44 1,500 1,000 500 0-500 -1,000-1,500-2,000 263 267 (213) (118) 1,319 (1,518) 550 09 10 11 484 (66) (44) (203) (202) (329) (550) 12 499 13 51 440 202329 20133 207714 2 79.6% 82.9% 54.8% 54.9% 57.1% 57.5% 90.6% 83.1% 54.3% 52.2% 62.3% 114.8% 17.5% 8.5% 431.2% 218.4% 205.4% 195.9% 748.5 648.1 42.7 37.4 57.9 56.9 56
201331 991 18 20143 118 1 20 18.00 18.00 18.00 18.00 18.00 100.0 260 10 13030 EBITDA54063 1100115 15 10 5 0 35.8 34.1 09 10 42.6 11 82.9 12 71.2 13 80.0 60.0 40.0 20.0 0 3,690 3,477 213 6.1% 260 250 10 3.8% 130 100 30 29.4% 20143 3,690 213 57
58
59
201320123 18,753 12,953 $ 199,500 86,463 99,118 919,819 2,897 2,971 30,819 95,093 99,653 1,011,628 34,574 25,050 367,808 (105) (110) (1,117) 132,459 127,564 1,409,138 62,689 58,118 666,904 30,098 31,783 320,191 2,977 4,715 31,671 333,439 334,251 3,547,223 10,277 10,248 109,330 92,586 91,116 984,957 105,353 104,959 1,120,777 5,799 2,121 61,691 214,015 208,444 2,276,755 (144,153) (141,747) (1,533,542) 69,862 66,697 743,213 980 973 10,426 40,059 29,083 426,160 71,294 64,311 758,447 50,664 5,660 538,979 24,352 37,735 259,064 7,570 11,625 80,532 8,999 9,075 95,733 203,918 158,462 2,169,341 607,219 559,410 $ 6,459,777 60
20,000 10,000 $ 212,766 176 44,518 2,118 46,812 2,115 44,404 11,500 124,831 151 42,488 2,280 44,919 5,437 40,163 5,447 105,966 1,872 473,596 22,532 498,000 22,500 472,383 122,340 1,327,989 95,000 11,030 27,110 133,140 118,000 10,790 5,427 134,217 1,010,638 117,340 288,406 1,416,384 22,400 22,400 238,298 15,860 308,557 (651) 15,860 305,664 (649) 168,723 3,282,522 (6,926) 346,166 343,275 3,682,617 14,121 (11,039) 3,082 349,248 607,219 8,016 (32,064) (24,048) 319,227 559,410 150,223 (117,436) 32,787 3,715,404 $6,459,777 61
201320123 201320123 347,724 101,686 246,038 220,994 25,044 1,091 (1,072) (417) (4,841) (1,090) (557) (6,886) 18,158 6,788 1,326 8,114 10,044 25.28 18.00 10,044 6,105 21,025 27,130 37,174 37,174 350,396 98,857 251,539 231,137 20,402 1,025 (1,123) (2,338) (224) 1,241 (1,224) (1,431) (4,074) 16,328 12,291 (4,593) 7,698 8,630 21.72 18.00 8,630 2,602 (8,836) (6,234) 2,396 2,396 $3,699,191 1,081,765 2,617,426 2,351,000 266,426 11,606 (11,404) (4,436) (51,500) (11,596) (5,926) (73,256) 193,170 72,213 14,106 86,319 $ 106,851 $0.27 0.19 $ 106,851 64,947 223,670 288,617 395,468 395,468 62
201320123 397,900 (587) 22,400 15,860 304,186 (649) 341,797 5,414 (23,228) (17,814) 323,983 (7,152) (7,152) (7,152) 8,630 8,630 8,630 (2) (0) (0) (0) 0 (0) 0 0 0 2,602 (8,836) (6,234) (6,234) 397,900 (589) 22,400 15,860 305,664 (649) 343,275 8,016 (32,064) (24,048) 319,227 (7,151) (7,151) (7,151) 10,044 10,044 10,044 (1) (2) (2) (2) (0) 6,105 21,025 27,130 27,130 397,900 (590) 22,400 15,860 308,557 (651) 346,166 14,121 (11,039) 3,082 349,248 $238,298 $168,723 $3,251,745 $(6,904) $3,651,862 $ 85,276 $(341,106) $(255,830) $3,396,032 (76,074) (76,074) (76,074) 106,851 106,851 106,851 (22) (22) (22) (0) 0 0 0 64,947 223,670 288,617 288,617 $238,298 $168,723 $3,282,522 $(6,926) $3,682,617 $150,223 $(117,436) $ 32,787 $3,715,404 63
201320123 18,158 31,312 417 3,773 (228) (1,091) 1,072 4,841 6,806 (3,732) (4,877) 6,837 63,288 1,442 (1,074) (3,627) (10,115) 49,914 (5,179) (7,818) (2,209) 18 (4,926) 3 (2,344) 265 (24,852) (7,981) 3 (55,020) (13,000) (2) (7,151) (68) (20,221) 4,582 (20,745) 92,179 71,434 16,328 36,468 2,338 3,764 (130) (1,025) 1,123 224 1,224 5,824 (2,585) (2,490) 1,570 62,633 1,349 (1,106) (14,493) 48,383 (6,715) (2,136) 1,945 5,348 363 (3,203) 47 (22) (4,373) (50,000) 19,895 15,000 (10,600) (1) (7,149) (68) (32,923) (1,776) 9,311 82,868 92,179 $ 193,170 333,106 4,436 40,138 (2,426) (11,606) 11,404 51,500 72,404 (39,702) (51,883) 72,736 673,277 15,340 (11,426) (38,585) (107,606) 531,000 (55,096) (83,170) (23,500) 191 (52,404) 32 (24,936) 2,819 (264,383) (84,904) 32 (585,319) (138,298) (21) (76,074) (725) (215,118) 48,745 (220,692) 980,628 $ 759,936 64
2013731 1 1897514 2005101 2-6-8 TEL06-6203-5321 FAX06-6202-6028 1-13-1 TEL03-5159-2500 FAX03-5159-2945 224 7,1294,502 397,900,154 2 27,479 4506 331 6 SMBC UFJ 22 4 2 2 DSP& DS DS 199,434 50.20 27,282 6.87 15,265 3.84 9,477 2.39 8,982 2.26 7,000 1.76 5,776 1.45 4,441 1.12 4,435 1.12 BNY GCM CLIENT ACCOUNT JPRD AC ISG FE-AC 3,920 0.99 8.75% 10.05% 1.71% 19.33% 0.15% 60.01% 2,000 120,000 100,000 1,500 80,000 1,000 60,000 40,000 500 20,000 0 0 65
http://www.ds-pharma.co.jp 541-0045 2-6-8 TEL 06-6203-5321FAX 06-6202-6028 104-8356 1-31-1 TEL 03-5159-2500FAX 03-5159-2945 201371