Post on 31-Jan-2017
transcript
0
250
500
750
1,000
2013/3 2014/3 2015/3 2016/3
1,000
631
456
286
Net sales(JPY million)
*NoteThe increase in net sales from the following items is not reflected in this annual net sales forecast.1. Europe: Public medical insurance coverage2. United States: FDA approval3. Japan: Ministry of Health, Labour and Welfare /
PMDA approval
CYBERDYNE, Inc.
Consolidated Net sales
(annual forecast*)
2
Achieved55%
in the half-year555
Achieved 55% of annual net sales forecast
Consolidated financial results
Unit : JPY million
ItemFY2015 FY2015
(Apr. 1, 2015 - Sep. 30, 2015)
FY2014(Apr. 1, 2014 - Sep. 30, 2014)
+/- CommentsQ1 Q2
Net sales 170 385 555 212 343 Increase of sales of the new products(+ 300M)
Costs of sales 67 128 195 188 7 Cost reduction from mass-producing the new productsImprovement of service costs
Gross profit 103 257 360 24 335 Improvement of gross profit margin by 53%(12%→65%)
R&D expenses 126 190 316 321 -5 Continued clinical research and new product developments
Other SGA expenses 297 277 575 460 115 Increase of pro forma standard taxation that accompanies capital increases(+50M)
Operating loss -321 -210 -531 -757 226 Non-operating income 63 160 223 401 -178 Reduction of subsidy income(-192M)
Non-operating expenses 12 68 80 13 67 Increase of loss on reduction of non-current assets(+ 56M)
Ordinary loss -270 -118 -388 -369 -19Net loss attributable to owners of the parent -268 -119 -387 -374 -13
【FY2015 2nd Quarter:Quarterly consolidated statements of income (cumulative)】
Positive factors:Net sales x2.6 (+ 343M), Improvement of Gross profit margin by 53% (12%→65%)Negative factors:Reduction of subsidy(248M: Subsidy income192+loss on reduction of non-current assets 56)、Increase of pro forma standard taxation that accompanies capital increases(50M)
CYBERDYNE, Inc.
2.6 times the net sales for the same period last year
3
45#
223#
0#
50#
100#
150#
200#
250#
2015 3 2015 9
HAL®FOR(CARE(SUPPORT(((LUMBAR(TYPE)(
44#
95#
0#
20#
40#
60#
80#
100#
120#
2015 3 2015 9
HAL®FOR(LABOR(SUPPORT((LUMBAR(TYPE)(
33#
97#
0#
20#
40#
60#
80#
100#
120#
2015 3 2015 9
HAL®FOR(LIVING(SUPPORT(((SINGLE(JOINT(TYPE)
3#
14#
0#
10#
20#
30#
2015 3 2015 9
CLEANING(ROBOT/(TRANSPORT(ROBOT
CYBERDYNE, Inc. 4
Number of units in operation ~New products~
Increased 2 to 5 times within this 6 month periodUnit:unit
x2.9
x4.7
x2.2
x5
As#of#the#end#of#Mar.,#2015
As#of#the#end#of#Sep.,#2015
As#of#the#end#of#Mar.,#2015
As#of#the#end#of#Sep.,#2015
As#of#the#end#of#Mar.,#2015
As#of#the#end#of#Sep.,#2015
As#of#the#end#of#Mar.,#2015
As#of#the#end#of#Sep.,#2015
111"
121"
100"
110"
120"
130"
2015 3 2015 9
HAL®FOR(MEDICAL(USE((LOWER(LIMB(TYPE)(
384"
469"
300"
350"
400"
450"
500"
2015 3 2015 9
HAL®FOR(LIVING(SUPPORT((LOWER(LIMB(TYPE)(
CYBERDYNE, Inc. 5
Increased steadily
9%
UNIT:unit
22%
Number of units in operation ~Existing products~
As#of#the#end##of#Mar.,#2015
As#of#the#end##of#Sep.,#2015
As#of#the#end##of#Mar.,#2015
As#of#the#end##of#Sep.,#2015
CYBERDYNE, Inc.
Product line-up ①
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HAL®FOR MEDICAL USE(LOWER LIMB TYPE)
The world’s first robot therapeutic device Certified as a medical device in EU in 2013
CYBERDYNE, Inc.
Product line-up ②
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HAL®FOR LIVING SUPPORT(LOWER LIMB TYPE)
HAL®FOR LIVING SUPPORT(SINGLE JOINT TYPE)
《New product (Feb.,2015)》
Current model was released in 2010
CYBERDYNE, Inc.
Product line-up ③
TRANSPORT ROBOT
CLEANING ROBOT8
HAL®
FOR LABOR SUPPORT(LUMBAR TYPE)
HAL®
FOR CARE SUPPORT(LUMBAR TYPE)
《New product (Sep.,2014)》《New product (Mar.,2015)》
《New product (Mar.,2015)》
《New product (Aug.,2015)》
CYBERDYNE, Inc.
■EU:Application for public health insurance coverage of the treatment with HAL for medical use was submitted in Germany in October ■US:Under review by FDA → Expected to be approved by end of FY2015(Mar.,2016)■JAPAN:Under review by Ministry of Health, Labour and Welfare → Expected to be approved by end of 2015
A. Progress of applications for approval as a
medical device and insurance
coverage
B. ProductDevelopment
■Vital sensor(palm-size device for monitoring indices of arteriosclerosis and electrocardiogram)→ Expected to be released within FY2015■Cleaning / transport robot and HAL(Lumbar type) → Addition and improvement of functions
C. Base strengthening
and development
D. BusinessDevelopment
■US:Planning to establish a branch in the US with several medical partners■Airport:Bringing about the future of airports utilizing next generation robots■Alliance:Accelerating the development of an artificial cerebellum and artificial
intelligence and the utilization of IoT and big data■CEJ:Launching international business hubs in Tokyo and Tsukuba area
■Tsukuba(HQ):Planning to expand R&D and experimental verification area■Tokyo(Kawasaki):Establishing a cutting-edge medical innovation center in the
National Strategic Special Zone■Fukushima(Koriyama):Constructing the Next-gen and Multi-purpose robotic
production base
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Business Highlights
CYBERDYNE, Inc.
A. Progress of applications for approval as a medical device and insurance coverage
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Germany Application for public health insurance
coverage was submitted Oct. 27, 2015(to InEK*) Oct. 31, 2015(to G-BA*)
2015年度中に
2015年末に
* InEK : Institute for the Hospital Remuneration System G-BA : Germany’s Federal Joint Committee
Applied to FDA (510k) Expected to be
approved by end of FY2015(Mar.,2016)
Expected to be approved by end of
2015Applied to PMDAMar. 25
CYBERDYNE, Inc.
A. Progress of approval in Japan
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After deliberations held on November 10, 2015 by the Pharmaceutical Affairs and Food Sanitation Council’s Medical Equipment and External Diagnosis Subcommittee, the device received the group’s consent. Nihon Keizai Shimbun(Nikkei) Nov. 11, 2015
NHK Nov. 10, 2015 http://cgi2.nhk.or.jp/nw9/pickup/index.cgi?date=151110_1
CYBERDYNE, Inc.
B. Product development:Vital sensor
World’s first!Daily measurements for signs of arteriosclerosis and electrocardiogram that cause cerebrovascular disease and heart disease* made possible
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Toward the establishment of a business for the prevention of cerebrovascular disease and heart disease
Combined with Big Data analysis, it can pave the way for early
detection and prevention
*top three leading causes of death in Japan according to the Ministry of Health, Labour and Welfare
CYBERDYNE, Inc. 13
C. Base strengthening and developmentCreating innovations faster than anyone else in the world by utilizing national strategic zones
Next-gen and Multi-purpose Robotic
Production Base
International Strategic Zone:Cybernics International Robot Innovation Base
National Strategic Special Zone:Cybernics International Innovation
Medical Business Base
Fukushima(Koriyama)
Tokyo(Kawasaki)
Tsukuba
Under construction
In preparationhttp://www.king-skyfront.jp/press/
CYBERDYNE, Inc.
D. Bringing about the future of airports utilizing next generation robotsBegan an alliance with Tokyo International Airport (Haneda) in Sep., 2015
Improving the work environment Creating valuable customer services
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Robots supportpassengers with
transporting luggage
Robots clean the airport
Robots support laborerswith lifting cargo
出典:日刊工業新聞
CYBERDYNE, Inc.
D. Alliance with PEZY/ExaScaler
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PEZY Computing and ExaScaler occupied the world’s top 3 at the Green500*
(2015/7)
Accelerating the development of an artificial cerebellum and artificial intelligence and the utilization of IoT and big data by using the world’s highest-grade supercomputers
http://www.green500.org/?q=lists/green201506* Ranking of the most energy-efficient supercomputers in the world
CYBERDYNE, Inc.
D. CEJ…Tokyo (Kawasaki King Sky Front)
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羽 田 空 港
京浜臨海部 ライフイノベーション 国際戦略総合特区
第3ゾーン(空港連携機能) 緑地
TIACT
土地区画整理事業 (22.7ha) H25年9月完了
㈱ヨドバシカメラ(8ha)
アッセンブリーセンターH17年事業開始
ANA殿町ビジネスセンター ・ケータリンク棟 H23年4月運営開始 ・管理棟 H26年7月運営開始
全日本空輸㈱(3ha)
オフィス棟(予定)
駅前広場
多目的広場エリア
産業交流施設エリア ・産業支援施設、国際会議場、 展示場等
アジアヘッドクォーター特区 (羽田空港跡地)
ホテル・複合業務施設エリア
キングスカイフロント (約40ha)
<第1ゾーン> (宅地面積:約11ha)
周辺地域との共生に配慮し、地元の過去の経緯を踏まえた土地利用を促進 ●産業交流施設 ((仮称)羽田グローバルアライアンスセンター) ●多目的広場 ●駅前広場
羽田クロノゲート ( 10ha) H25年9月稼動
大鳥居
羽田 2丁目
大師河原
殿町 3丁目
川崎生命科学・環境研究センター (LiSE)(0.7ha)H25年3月運営開始
ものづくりナノ医療イノベーションセンター(i CON) (0.8ha)H26年度運営開始予定
・東大、東工大、富士フイルム、ニコン等
の産学官による「ナノ医療」研究開発など
「nature」 2009.5.28号
実中研再生医療・新薬開発センター (0.6ha)H23年7月運営開始
<第2ゾーン>(宅地面積:約5ha) 24時間国際拠点空港化に伴い、国際線地区と
の補完的・一体的な土地利用を図る。 ●宿泊施設●複合業務施設
国際線地区
「nature」 2009.5.28号
・貸し床(4F)
「(財)神奈川科学技術アカデミー」
「㈱エスアールエル」
「㈱天然素材探索研究所」
・環境総合研究所(3F)
・健康安全研究所(2F)
・共用施設(会議室、カフェ等)(1F)
・ヨドバシカメラアッセンブリーセンター
川崎増設計画を推進中
(環境アセス手続き中)
神奈川県ライフイノベーションセンター(仮称) (0.8ha)H28年度運営開始予定
・神奈川県が整備する再生・細胞医療分野
の研究開発センター
大田区
川崎市
(約1.0ha) H28年度竣工予定
・アイソトープ製品の試験・研究開発、
供給関連業務、普及啓発等
ジョンソン・エンド・ジョンソン㈱ 東京サイエンスセンター (0.3ha) H26年8月 運営開始
・医療機器の評価・開発 ・国内外の医師が医療機器のトレーニングで利用 など
国立医薬品食品衛生研究所 (2.7ha) H28年度工事完成予定
・医薬品、食品等の品質、安全性並びに有効性の評 価に関する試験・研究を実施 ・地方衛生研究所や検疫所に技術指導を行うほか、 世界各地からの研究者の受入、研修等を実施
○健康安全研究所との連携による市民 生活に密接に関連する食品などの安 全確保や市民の生活環境の維持・向 上への貢献に期待
クリエートメディック株式会社(0.3ha) 平成28年度竣工予定
・シリコン製カテーテル等の研究開発など
NOGマウス/ヒト化マウス
・再生医療による脊椎損傷やアルツハイマー治療などの
先端医療の実現を目指す
コモンマーモセット
大和ハウス工業株式会社(4.6ha) 土地譲渡契約:平成26年6月30日
富士フイルムRIファーマ株式会社(0.35ha) 土地落札日:平成26年8月8日
CYBERDYNE株式会社(1.5ha) 土地落札日:平成26年8月8日
羽田空港周辺の土地利用計画 National!Strategies!in!HANEDA!Airpot!Area
1.5ha(15,000m2),!!8!Aug.2014
Tokyo!Univ,TIT,Fuji!Film,!Nikon
Medical!Innovation!Center,Nano!Medicine!Factory
Life!Science!Center
Health!&!Safety,!Life!Environment,!Natural!material
Center!for!!!!Regeneration!Medicine!and!!!!!!New!Drag!Development
Regeneration!Medicine!for!Spinal!Cord!Injury,!New!Drag!Development!for!ATlzhèimer's
Fuji!Film!RI!Pharmacy
Daiwa!House
Create!Medtech
Asia!Head!Quater!National!Special!Zone
King!Sky!Fronttotal:!40!ha
羽田空港
Zone1!
Industrial!Alliance
Zone2!24!hours!Business!Center!&!Hotel
Zone3!Airport!Liaison!Complex
HANEDA!!International!Airport
Tokyo!Science!CenterMedical!Device!Development!Center!Medical!Device!Training!Center
International!Strategical!Zone!!for!
Life!Innovation
National!Food!&!Drag!Research!Center
FDA!style!Investigation!&!Evaluation!!of!!Safety,!Efficiency!!!
on!Medicine,!Foods,!Medical!Device!
Collaboration!with!!Health!&!Safety!Research!Center!!
in!daily!Life!
Japan!Isotope!!Association
Investigation!and!Development!on!Isotope!Products
Yodobashi
Assembly!!Center
Kanagawa!Life!Innovation!Center
Regeneration!Medicine,!Cell!Medicine
Physical!Distribution!Center
国家戦略特区 (医療産業イノベーション)
東京国際空港(羽田)
CEJ:サイバニクス・エクセレンス・ジャパン ・ CEJ(サイバニクス・エクセレンス・ジャパン)の設立へ
内閣府「革新的研究開発推進プログラムImPACT」で育成された ・「イノベーション創出の仕組み」・技術・人材・企業を対象に、
・サイバーダインの機能・認証取得ノウハウ・事業展開ノウハウを提供し、 ・「医療関連VB創出」を推進する。
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Tokyo International Airport
National Strategic Special Zone for innovation of Medical industry
Establishing CEJ (Cybernics Excellence Japan)
Targeting the technology, personnel, businesses, and “System for producing innovation”, cultivated by the Cabinet Office’s Impulsing Paradigm Change through Disruptive Technologies (ImPACT) Program, Cyberdyne will provide its functionality, certification acquisition know-how, and business development know-how to advance the production of medical venture businesses.
CEJ: Cybernics Excellence Japan
CYBERDYNE, Inc.
This presentation contains forward-looking statements that reflect Cyberdyne and Cyberdyne group’s forecasts, plans and expectations.The forward-looking statements reflect knowledge and information available at the date of preparation of the presentation, including publicly available information that have not been verified or guaranteed, and Cyberdyne undertakes no obligation to update these forward-looking statements.
Although we believe our forecasts, plans and expectations are based on reasonable assumptions, these forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that may cause Cyberdyne’s actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by these forward-looking statements.
CYBERDYNE, Inc.
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