Download Supplement Documents for Financial Results FY12/14

Supplement Documents for
Financial Results FY12/14
February 13, 2015
Chiome Bioscience Inc.
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
Securities code: 4583
Agenda
 Overview of FY12/14 “Financial Results”
 Overview of FY12/14 “Operating Highlights”
 Toward Achieving Our Vision and Financing
 Mid-term Management Plan FY2014-2016
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
2
Financial Results: Profit and Loss Situation on a Consolidated Basis
1,500
1,184
1,143
（¥million）
1,000
576
567
500
277 277
0
Net sales
COS/SGA
R&D expenses
Other costs
Operating
income
Ordinary
income
Net income
▲ 500
▲ 865
▲ 883
▲ 863
▲ 907
▲ 891
▲ 907
▲ 1,000
▲ 1,500
FY12/14 Forecast
FY 12/14 Result
* FY12/14 consists of nine months from April 1, 2014 to December 31, 2014.
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
3
Balance Sheet on a Consolidated Basis
（¥million）
As of December 31, 2014
As of March 31, 2014
Liabilities 417
Liabilities 453
現預金
4,349
現預金
Cash on hand
2,580
and
Cash on hand
Cash on hand
and
and
in banks
in banks
Net assets
4,349
2,580
4,559
Other current assets 164
Property, equipment
and Intangible assets 425
Other non-current assets 72
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
in banks
5,575
Net assets
5,839
Other current assets 160
Property, equipment
and Intangible assets 447
Other non-current assets 72
4
Financial Results: Cash Flows on a Consolidated Basis
6,000
(¥ million)
5,500
5,000
5,075
4,500
4,000
3,500
2,130
4,349
▲789
3,000
▲618
2,500
2,000
1,500
1,000
Cash and cash equivalents Cash flows from operating Cash flows from investing
as of the beginning of the
activities
activities
period
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
Cash flows from financing Cash and cash equivalents
activities
as of the end of the period
5
Agenda
 Overview of FY12/14 “Financial Results”
 Overview of FY12/14 “Operating Highlights”
 Toward Achieving Our Vision and Financing
 Mid-term Management Plan FY2014-2016
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
6
Operational Highlights (1)

Drug Discovery Alliance
 Chiome Bioscience has renewed its agreement with the Chugai
Pharmaceutical group to continue research and development activities.
 In addition to the existing ADLib® system, the company has also
commenced marketing its fully human ADLib® system with the aim of
concluding verification agreements.
 Livetech Inc., a consolidated subsidiary, has achieved the milestones on
preclinical trials with its LiV-2008 anti-cancer antibodies, and is receiving
payments from Yakult Honsha.

Lead Antibody Licensing
 Drug efficacy tests are being conducted using animal models of
inflammatory diseases and cancer in a bid to build attractive out-licensing
packages.
 In its joint-research activities with UK-based Biotecnol, Inc., research and
development activities are progressing steadily for new therapeutic
antibodies in the field of cancer.
 Joint-research activities have started with the Uemura Laboratory of the
Nagoya City University and the Takei Laboratory of the Yokohama City
University.
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
7
Operational Highlights (2)

Licensing Out Platform Technology
 Chiome Bioscience recorded revenues through royalties commensurate to
the sales of a diagnostic kit (Lumipulse® G25-OH Vitamin D
Immunoreaction Cartridge), which was developed by Fujirebio, a
technology licensee of the original ADLib® system. In addition, research
and development activities aimed at producing a new diagnostic kit that
uses ADLib® system remain ongoing.
 Chiome Bioscience has been talking to multiple companies interested in
licensing the technology inside and outside Japan regarding pilot studies
for technological assessment and technological licensing schemes.

R&D Results
 Chiome Bioscience is working to improve the diversity levels of a fully
human ADLib® system.
 The Company is continuing to generate specific antibodies against tough
antigens using the existing library, upgrade and expand the pipeline, and
create strategic antibodies.
 The Company has successfully created antibodies against certain proteins
for each of the influenza and Ebola viruses.
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
8
R&D: Progress in Drug Efficacy of Anti-semaphorin 3A Antibody
Promising result Inflammatory disease models and preliminary in oncology
Sema3A specific
antibodies
Inhibition of axon
repulsion
 Focus on unmet needs in a disease where primary disease
is sepsis
 Disseminated intravascular coagulation syndrome (DIC)
 Sema3A promotes migration of certain types of cancer cells
 Possibilities to block metastasis in sema3A overexpressing cancers
Improved survival in
sepsis model
Prognosis factor in DIC
Inhibition of PAI-1 elevation
Effectiveness testing of
Anti-sema 3A in DIC
Effectiveness testing of
Anti-sema 3A in sema-3Aoverexpressed cancer cell
Inhibition of sema3A-induced
cancer cell migration and
invasion
Chimeric antibody
Chicken IgM
antibody
・・・・・・・・
Humanized antibody
Mar. 31
 2013
Continue to conduct exploratory research
into new drug efficacy
Q1
Q2
Present
2014 
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
9
Sema3A Stimulates Cancer Migration/Invasion
 Metastasis is a major factor that threatens survival of cancer patients
 Infiltration of cancer cells lead to cancer metastasis
Propagation
in metastatic
tissues
Migration anallysis
Cancer cell
Extracellular
matrix
Invasion
Degradatio
n of ECM
Sema3A
Engraftment in
distant tissue
Vascular
invasion
Emigratio
n
Sema3A (－)
Sema3A ( ＋ )
Sema3A accelerates degradation of extracellular matrix in cancer
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
10
Inhibition of the Cancer Cells Invasion
1000
1000
800
800
Cell number (well)
Cell number (well)
 Poor prognosis in Sema3A-expressing pancreatic cancer patient
 High recurrence rate after excision in pancreatic cancer
600
400
200
* reference: Int. J. Cancer 2421-2433, 2007
600
**
***
1
10
400
200
0
0
Sema3A Sema3A
(－)
100ng/mL
(－)
0.1
anti-Sema3A (mg/mL)
0.1
1
10
Control IgG (mg/mL)
Sema3A 100ng/mL
Sema3A accelerates invasion
anti-Sema3A mAb inhibits Sema3A-induced
of pancreatic cancer cell line
Invasion in dose dependent manner
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
11
Toward Achieving Our Vision: Chiome’s Vision
A healthcare innovator creating drugs that are 100% effective
Establishment of the fully
human ADLib® system
(2014)
Countermeasures for
pandemic diseases
(2018)
The ultimate
made-to-order medicine
(2023)
Creation of a technology capable of
discovering antibodies that can be
administered to people in only a
few weeks
Replacement of vaccines using the
fully human ADLib® system
Achievement of a revolutionary
therapeutic effect by providing
individual patients with the custom
made antibodies very rapidly
Contributing to Human Society
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
12
Opening Moves in Achieving Our Vision from the Fully Human ADLib® System
Shift to the commercialization phase and generation of strategic
antibodies
The Fully Human ADLib® System
Lead Antibody Licensing
Practical introduction of the ADLib® system to
generate antibodies for expanding pipelines
Licensing Out Platform Technology
Improvement in diversity
Start to license out
Strategic antibodies to achieve our vision (Active Sonar)
Countermeasures for pandemic diseases
Start to generate strategic antibodies
Candidate target: emerging infectious disease
The Ultimate made-to-order medicine
Start to consider the target of strategic antibodies
Candidate target: rare intractable diseases
*Active Sonar… refers to lead antibodies driving the business of Chiome Bioscience, which can be used for
business development, clinical trials, and other activities useful for realizing the Company’s vision.
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
13
Antibody generation from human ADLib® library




Library : Fully human library
Target ： Antigen A (Extracellular domain of TM protein)
Panning: magnetic and FCM sorting
Screening: ELISA
Result of ELISA
Antigen A
Trypsin inhibitor Streptavidin
Ovalbumin
4.0
3.5
OD450nm
3.0
2.5
2.0
1.5
1.0
0.5
0.0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Antigen specific human IgGs are obtained
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
14
Antibody generation to the Epidemic targets
Ab generation with Original ADLib (chicken IgM Library)
Ab generation to Target X
ELISA screening
After panning
3.5
Target X
OA
SA
3.0
OA, SA: control
proteins
2.5
OD450
Target binding
Target binding
Before panning
4.0
2.0
1.5
1.0
0.5
Surface antibody
361
362
365
366
375
376
378
381
384
386
390
392
0.0
Surface antibody
Clone #
Surface antibody
OD450
Target binding
Target binding
Ab generation to Target Y
Surface antibody
4.0
3.5
3.0
2.5
2.0
Target Y
OA
SA
1.5
1.0
0.5
0.0
7 12 14 17 27 32 40 45 47 51 52 53
Clone #
Specific Abs to the epidemic pathogens were obtained.
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
15
Agenda
 Overview of FY12/14 “Financial Results”
 Overview of FY12/14 “Operating Highlights”
 Toward Achieving Our Vision and Financing
 Mid-term Management Plan FY2014-2016
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
16
Vision 2018:Countermeasures for the Pandemic Disease
Pathogens threatening the world society
 Bioterrorism: CDC category A~C
 Outbreaks : Ebola(2014), Dengue(2014), Cyclosporiasis, MERS (2013), West Nile virus ,
E.coli O145 (2012)
 Epidemic : Influenza
Timeline of pandemic Flu
Number of specimens
positive for Flu
Vaccine can not protect people from the first pandemic
Timeline of
Chiome
Timeline of
vaccine
Production
1st Event
Modified from WHO web site
Titer increase
Administration
Production
1st Event
Reduce
Reduce
Administration
Social demands: Medical Countermeasures promptly responding to unknown pathogens
Chiome’s goal: Respond Pandemic within one month after 1st event
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
17
Financing through a public offering and third-party allotment
Having raised ¥ 2 billions, we are accelerating our
R&D activities in infectious disease field.
【Outline】
 Offering format: Domestic public offering and third-party allotment
 Offering number of shares: 1,656,000 shares
(Public offering: 1,440,000 shares / third-party allotment： 216,000 shares）
 Net amount of financing: 2,004 millions
【Purpose of the financing ・・・to invest in the infectious disease field 】
 To create multiple promising pipelines through the more aggressive and rapid
R&D activities and the technical innovation.
 To broaden opportunities in which we can put forward alliance proposals to the
companies that have original excellent technologies.
 To acquire other company’s technologies or targets and launch a new base.
Early realization of our vision & increasing of the corporate value
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
18
Uses of financing
(¥million)
Basic use
Amount
Investment capital and various costs to acquire technologies in the area of
therapeutic antibodies
235
Funds for capital investment for the management of its domestic research
facilities and for research
165
Technologies to establish an antibodies drug-discovery platform, costs to
acquire licenses from targets, etc.
400
Research costs, such as for screening, in order to acquire new antibody
candidates for contagious diseases
361
Physical property and drug efficacy tests for lead antibody candidates
457
Costs for joint research with overseas research facilities
250
Development of next-generation technologies
135
Total
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
2,004
| 2/13/2015 |
19
Launch of a new domestic laboratory in Kawasaki, Japan
Accelerating the R&D activities at an international strategic
center for the life science.
Expectations for the new laboratory
 Speed up of the R&D activities in the field of infectious disease aiming to
realize our vision.
 Early establishment of an out-license data package through the one stop
service from the generation of antibodies to the animal testing.
 Accelerating of the open innovation by going into the biocluster.
 Possibility of support from the government or the autonomies with the
authorization for support.
http://www.king-skyfront.jp/institution/
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
“Kawasaki city” Science 2013
20
The KING SKYFRONT Innovation Hub for 21st Century Life Science
 The mission of this futuristic facility is to find actionable solutions to issues in
regenerative medicine, cancer treatment, and the prevention of ‘lifestyle’
diseases such as obesity.
 the Japanese government has designated the KING SKYFRONT to be a special
zone for international competitiveness development, bestowing it special
privileges including reduced corporate taxes and government-backed financial
support for projects launched there.
“Kawasaki city” Science 2013
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
21
Agenda
 Overview of FY12/14 “Financial Results”
 Overview of FY12/14 “Operating Highlights”
 Toward Achieving Our Vision and Financing
 Mid-term Management Plan FY2014-2016
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
22
Mid-term Management Plan (a Three-Year Plan)：
Consolidated Profit-and-loss Plan
Aiming to recover upfront investments in technological innovation
starting in FY12/16
(¥ million)
Net Sales
Operating Income
Ordinary Income
Net Income
4,000
3,452
3,000
2,000
651
670
1,000
655
670
277
0
▲ 1,000
▲ 865
▲ 883
▲ 863
▲ 1,967 ▲ 1,923 ▲ 1,921
▲ 2,000
FY12/14*
Result
FY12/15
Forecast
FY12/16
Forecast
* FY12/14 consists of nine months from April 1, 2014 to December 31, 2014.
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
23
Mid-term Management Plan (a Three-Year Plan)：
Consolidated Sales Plan by Segment
Conversion to highly added value business model
Drug Discovery Alliance
Out-licensing of
the fully human
ADLib® system
(¥ million)
5,000
4,500
Lead Antibody Licensing
Building the
pipelines
continuously
Licensing Out Platform Technology
4,000
3,500
3,000
2,378
2,500
2,000
1,500
1,000
500
23
254
49
300
321
460
614
0
FY12/14
Result
FY12/15
Forecast
FY12/16
Forecast
* Growth trend is shown by the curved lines.
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
24
Ethics & Transparency
Evolution & Creation
Chiasma & Global Exchange
We strive to be a sound, well-respected company that values human life.
We strive to create the future through the development of each person and the
company as a whole.
We are committed to the transcendence of national and international borders.
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
Disclaimer
•
Materials and information provided during this presentation may contain
so-called “forward-looking statements.” These statements are based on
current expectations, forecasts and assumptions that are subject to risks
and uncertainties, which could cause actual outcomes and results to
differ materially from these statements.
•
Risks and uncertainties include general industry and market conditions,
and general domestic and international economic conditions such as
interest rate and currency exchange fluctuations.
•
The Company disclaims any intention or obligation to update or revise
any forward-looking statements whether as a result of new information,
future events or otherwise.
Copyright © 2015 Chiome Bioscience Inc. All Rights Reserved.
26