Financial Results FY12/15 and New Business Strategy · and New Business Strategy. ... LIV-2008;...
Transcript of Financial Results FY12/15 and New Business Strategy · and New Business Strategy. ... LIV-2008;...
Copyright © 2016 Chiome Bioscience Inc. All Rights Reserved.
12 February, 2016Chiome Bioscience Inc.
Securities code : 4583
Financial Results FY12/15and New Business Strategy
Copyright © 2016 Chiome Bioscience Inc. All Rights Reserved. 2
Agenda
Overview of FY12/15 “Financial Results”
Overview of FY12/15 “Topics in Operation”
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Financial Results: Profit and Loss
(¥million)
254
1,666
▲ 1,412 ▲ 1,407 ▲ 1,437
280
1,549
828721
▲ 1,269 ▲ 1,253 ▲ 1,282
▲ 2,000
▲ 1,500
▲ 1,000
▲ 500
0
500
1,000
1,500
2,000
Net sales COS / SGA R&D expenses Other costs Operatingincome
Ordinaryincome
Net income
FY12/15 Forecast FY12/15 Result
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Financial Results: Balance Sheet
As of December 31, 2014 As of September 30, 2015(¥million)
Cash on handand
in banks
5,418 Net assets
5,815
Other current assets 156Property, equipment
and Intangible assets 419Other non-current assets 117
Liabilities 296
Othercurrent assets
2,972
Cash on handand
in banks1,301
and Intangible assets 458Property, equipment
Other non-current assets 186
Liabilities 354
Net assets4,564
Working capital¥4,000m
On July 1, 2015, the Company has totally merged with its only consolidated subsidiary Livtech, Inc. and its consolidated subsidiary no longer exists. As a result, each figure is showed on the Company's non-consolidated basis.
Copyright © 2016 Chiome Bioscience Inc. All Rights Reserved. 5
Agenda
Overview of FY12/15 “Financial Results”
Overview of FY12/15 “Topics in Operation”
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Topics and Operation (1)
Business development activities Due to its unique features, the fully human ADLib® system is
attracting wide acclaim from pharmaceutical companies. In order to out-license the ADLib® system under favorable financial conditions, we are accumulating further successful cases of antibody generation through collaborations. We plan to promote antibody generation projects for targets for which clinical proof of concept has already been achieved.
An Option License Agreement for a worldwide exclusive license for the development of LIV1205 as an Antibody Drug Conjugate (“ADC”) has been concluded with Switzerland-based company, ADC Therapeutics SA (“ADCT”)
“ADC” ADCs are monoclonal antibodies attached to biologically active drugs with chemical linkers. By combination the unique targeting of antibody with anti-cancer drugs, ADCs allow sensitive discrimination between healthy and diseased tissue.
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Topics and Operation(2)
R&D Results Continuation of research activities for refining fully human ADLib®
system and developing therapeutic antibodies by using the ADLib®
system. The former LivTech laboratory has been upgraded and expanded to
a drug discovery laboratories, which had already commenced its operation.
Drug Discovery Alliance Chiome Bioscience has renewed its agreement with the Chugai
Pharmaceutical group to continue research and development collaboration.
LIV-2008; terminated the agreement with Yakult Honsha, settlementprocedures were completed and an amount totaling ¥24,927 thousand posted for the current period.
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Topics and Operation(3)
Lead Antibody Licensing Seeking out-licensing opportunities of humanized anti-semaphorin
3A antibodies (BMAA) during current period.
LIV-2008, humanized anti-TROP-2 antibody, has been introduced to pharma companies through One-on-One meetings at conferences. For LIV-1205 and LIV-2008, we are working on aggressive promotion activities towards out-license deals.
Licensing Out Platform Technology Receiving license fees from Fujirebio for its use of the original
ADLib® system. Expecting their R&D activities aimed at developing new diagnostic kits based on the ADLib® system.
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Investment in EVEC, Inc
9
Strengthening R&D capability in infectious diseases by synergizing with EVEC, Inc.
EVEC, Inc.Venture backed biotech, EVEC owns an unique technology to develop fully human antibodies from human B cell lymphocytes which are responsible for antibody production in the body. They have track records to develop lead antibodies for infectious diseases, and signed license agreements with Boehringer Ingelheim and Astellas Pharma.
Established January 10, 2003
Officer Kenzo Takada, MD, PhD, Representative Director, ChairmanHisato Doi, Representative Director, President
Office Mitsuiseimei-Odori Bldg 8F,Odori W6,Chuo-ku,Sapporo
Directors and employees 19 (6 Directors, 13 Employees)
Capital 419 million yen
Execute an investment in capital of to EVEC, Inc. and to build collaboration with them having complementary technology of ADLib® system
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Option License Agreement for LIV-1205, an anti-cancer antibody
Receive up to max 9 billion yen milestones
In total 9 billion yen Milestones + Royalties
In the Option License Agreement, Chiome granted ADC Therapeutics (ADCT) an option to a worldwide exclusive license to develop LIV-1205 as an ADC for anti-cancer therapeutic use.
Upfront payment on execution of this Option License Agreement
Upfront payment on execution of the option right upon evaluation
under Option License Agreement
Milestone payments based on the progress of development
Royalties based on the sales in market
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Current progresses in ADLib® system
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Fully human ADLib ® system
Original and mouse chimeric ADLib® system
Successfully generated new antibodies for a Japanese pharma to support their drug development
Enhancement of efforts to obtain new contracts in the field including infections diseases
Needs functional evidence by further accumulation successful cases of antibody generation, to develop our business
【Out-Licensing】Needs many successful cases in generation of human antibodies to
obtain pilot-study agreement to evaluate the technology.
【Library Development, Antibody generation】 Securement of library diversity as well as original ADLib® system Antibodies against same target as launched antibody were
successfully obtained, as evaluation of library performance.
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Topics : Fiscal 2015
13
Execution of Option License Agreement for LIV-1205 with ADC Therapeutics
Integration with LivTech and reorganized into Drug Discovery Laboratories
Investment in EVEC, Inc
An Option License Agreement for a worldwide exclusive license for the development of LIV-1205 as an Antibody Drug Conjugate (“ADC”) has been concluded with ADC Therapeutics (“ADCT”). In addition to an upfront on signing the agreement Chiomewill receive from ADCT an Option fee on exercising of the option right. In total Chiome are eligible to receive up to 9 billion yen plus royalties based on the sales.
LivTech, Inc. (“LivTech”) was fully merged into Chiome. The former LivTechlaboratory has upgraded and expanded its human resource and research facility as a Drug Discovery Laboratory, which commenced its operation.
To contribute to achieve business vision and boost the corporate value, Chiomehas invested into Evec who possesses proprietary platform technologies for generating fully human antibodies from human B lymphocyte which is responsible for antibody generation in the body, also has track record of out-licensing lead antibodies to pharmaceutical companies.
Copyright © 2016 Chiome Bioscience Inc. All Rights Reserved.
Key strategies for the rapid growth in the future
A Two-pronged Growth Strategy
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Strengthening drug discovery engine through strategic alliances
Fulfilling and advancing development of pipelines
Promote strategic alliances to enhance the capability of drug discovery using ADLib® system and establish drug discovery platform.
Generating competitive antibodies against new targets of unmet medical needs
Antibody against validated targets with high probability of success in development.
Consider conducting early clinical study to add values to pipeline antibody
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Empower drug discovery engine through strategic alliances
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Expansion of Antibody Drug Pipeline
ADLib® system + Other Drug Discovery technologies
Promoting new collaborative research and business alliance for the enhancement of drug discovery technology in the future
Track records to develop lead antibodies Platform of evaluation of drug efficacy
ADLib® system
Drug Discovery Platform
Investment
Merger with Chiome
Collaborative research
Enhancement of Drug discovery technology
Track records to develop lead antibodies Antibody production using EB virus
Academia Pharmaceutical companies
Identification of antibody drug candidates
Antibody generationInnovation of new technology
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A Scenario for Expanding Pipeline
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Basic research, Drug Discovery Pre-clinical study Clinical study Approval Launch
LIV-2008
ADLib® system
LIV-1205
New targets in unmet medical needs area
Development of Pipeline
Important POINT ①
Important POINT②
CBAntibody generation technology A Antibody engineering
Animal study
Antigen preparation
Development of Drug Discovery Platform
BMAA(Anti-Sema3 A antibody)
Validated targets which have high developability
Consideration of further development
Brushup of each technology
Synergistic value-up
Enhancement generation power Establishment of drug discovery technology
NewPipeline
NewPipeline
NewPipeline
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Further development for early phase clinical study
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Milestone
Upfront level
売上Estimated timing of
out-licensing
Planning further development for early clinical study and maximizing antibody value for out-licensing with good deal
early late
Developmentcosts
Increase greatly
Increase total value of contractIncrease loyalty rate
In case of advanced developmental stage
Increase own development costs
Basic research, Drug Discovery
Pre-clinical study Clinical study Approval Launch
※Expectation for effect of shortening of period toward launch
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Pipeline - Therapeutic antibody -
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Project Target TherapeuticArea
Basic research, Drug Discovery Pre-
clinical Study
Clinical Study Partner
Search of Drug Target
LeadSelection
LeadOptimization
LIV-1205 DLK-1
Oncology
Oncology/ADC
LIV-2008 TROP-2Oncology
Oncology/ADC
BMAA SEMA3A suspense
New PJ Undisclosed
ADCT
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Features of LIV-1205
Project code : LIV-1205 (Humanized)
Potential drug candidate for liver cancer treatment, currently limited treatment options to cancer patients
First-in-class therapeutic antibody, targeting intractable cancers such as liver cancer etc.
DLK-1, a cell surface protein, is a therapeutic target. DLK-1 exhibits a very low level in normal tissue and increases a high expression level in cancer cell surface.
Expectation for development as a therapeutic agent with little side effects
Naked LIV-1205 antibody exhibited a noticeable inhibition effect on tumor growth whenadministered alone using animal model
Antibody Drug Conjugate (ADC) approach is one of options in drug development becauseLIV-1205 has an internalization activity that is taken into cells after binding to antigen
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Mechanism of action and expected effects of LIV-1205
NK-cell macrophage
- Naked antibody- - ADC antibody-
① Growth inhibition of cancer cell② apoptosis induction of cancer cell
(caspase 3 activity↑)③anti-tumor effect by inductionADCC/ADCP activity※
“internalization ※※”
“clearance of anticancer drug”
Anti-tumor effect based on characteristics of anticancer drug
Anticancer drug
DLK-1
Development of therapeutic antibody to utilize anti-tumor effect (①〜③) of Naked antibody
Development pf ADC antibody to utilize an internalization activity
In addition to ADC approach, Naked antibody can be expected to have anti-tumor effect
(concluded an Option License Agreement with ADCT)
DLK-1
Cell membrane
(Aim for licensing out to pharmaceutical company)
Cell membrane
※A naturally immune function in human. The activity that a white blood cells kill targeting cells, such as cancer cell or taken into the cell and break down
※※A phenomenon that antibodies will be taken into cells after binding the antigen
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Features of LIV-2008
Project code︓LIV-2008/LIV-2008b(Humanized)
Exception for development of various intractable solid cancer
Best-in-class therapeutic antibody, targeting various cancer typeTwo type of therapeutic antibody, recognizing different epitope and having different character
TROP-2, cell surface protein is a target. Expression of TROP-2 increased in various cancer type. TROP-2 is attracting molecule as a therapeutic target for cancer treatment.
Expectation for development as a therapeutic agent with little side effects
Potent anti-tumor activity was observed in various cancer with Naked antibody (LIV-2008)
alone using animal model.
ADC approach is one of options in drug development, because LIV-2008b has aninternalization activity that is taken into cells after binding to antigen.
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Mechanism of action and expected effects of LIV-2008/LIV-2008b
TROP-2
Development of multifunctional therapeutic antibody to utilize anti-tumor effect (①) and ADCC/ADCP activity (②)
LIV-2008 and LIV-2008b having different characteristics are expected as a treating method of various solid cancer
TROP-2
“LIV-2008b”“LIV-2008”
LIV-2008 has Growth inhibition activity and is enhanced ADCC/ADCP activity by glycosylation
(Aim for licensing out to pharmaceutical company)
(Aim for licensing out to pharmaceutical company)
- Naked antibody- - ADC antibody-
NK-cell macrophage
Anticancer drug
Cell membraneCell membrane
“internalization ※※”
“clearance of anticancer drug”
① Growth inhibition of cancer cell②anti-tumor effect by inductionADCC/ADCP activity※
Development pf ADC antibody to utilize an internalization activity
※A naturally immune function in human. The activity that a white blood cells kill targeting cells, such as cancer cell or taken into the cell and break down
※※A phenomenon that antibodies will be taken into cells after binding the antigen
Internalization activity of LIV-2008b and anti-tumor effect based on characteristics of anticancer drug
Copyright © 2016 Chiome Bioscience Inc. All Rights Reserved.
Revision of segment
23
On January 1, 2016, the company is linked the report segment with new business development. The major changes are shown below.
Drug Discovery Alliance
Lead Antibody Licensing
Licensing Out Platform Technology
This is business to obtain upfront costs, milestone, royalties relating to out-licensing of platform technology for generation of therapeutic antibody or patents of drug discovery seeds, and income by collaborative research.
This is business to obtain income relating antibody generation service that necessary support for drug discovery research at pharmaceutical companies, or to offer our platform technology for diagnostic and research antibody generation.
Drug Discovery and Development
Drug Discovery Support
Drug Discovery and Development
Drug Discovery Support
Copyright © 2016 Chiome Bioscience Inc. All Rights Reserved.
New segment of business model and phylogram
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Upfront payment, Milestone payment, Royalties
Commercialization rights of antigen and antibody
Drug Discovery Platform
ADLib® system
Antibody engineering
+various Antibody generation technology
Animal study
Antigen preparationA
cade
mia
Drug Discovery and Development
Drug Discovery Support Ph
arm
aceu
tical
com
pani
es
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Revenue model
25
Basic/Discovery Study
Pre-clinical Study
Approval review
Marketing
Milestone Royalties
Pharmaceutical companiesAcademia
Chiome
ChiomePharmaceutical companies
Upfront
Licensing-out
Business Revenue
¥,$,€
¥,$,€
Clinical Study
Col
labo
rativ
e re
sear
chC
hiom
ePr
ojec
ts
Dru
g D
isco
very
and
D
evel
opm
ent
Drug Discovery Support
Pharmaceutical companies
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Long-term Business Strategy
26
Time
Com
pany
val
ue
2016 Early stage of growth
Late stage of growth
→Acquisition of stable earnings
LIV-2008LIV-1205
Drug Discovery Support
BMAA (Anti-Sema3A antibody)
New Pipeline
Source of growth
Drug Discovery and Development
Stable & Expanded stage
Focusing investment on Drug Discovery and Development business for enhancing a company's value
Generation, development, and out-licensing of pipelines
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Maximize value of Drug Discovery and Development Business
27
Ensure business fund from operational reforms and execute new corporate strategy
Downsizing of organization with the aim of coping with the cost of early clinical development for boosting corporate value
Acquiring stable earnings by promotion of Drug Discovery Support
Focusing on research that can obtain data required for out-licensing contract thoroughly
Optimizing number of employees by voluntary retirement
Copyright © 2016 Chiome Bioscience Inc. All Rights Reserved.
Fiscal 2016︓Sales of Drug Discovery Support and R&D Expenses
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0
100
200
300
400
500
600
700
800
900
1,000
Sales R&D Expenses
Result of fiscal 2015 Forcast fiscal 2016
¥million
Sales of Drug Discovery Support
Selection and concentration of research projects
Acquisition of stable earnings by Drug Discovery Support
227246
828
585
Copyright © 2016 Chiome Bioscience Inc. All Rights Reserved.
Our Mission
29
We revolutionize the medical care
We aim for “a conversion into business model that produce highly added value”
For all people around the world who are waiting for new medical care
We generate innovative therapeutic antibodies
We continuously generate novel drug discovery technologies based on diversity of genetic information
Copyright © 2016 Chiome Bioscience Inc. All Rights Reserved.
Contributing to Human Society
Our Vision
A healthcare innovator creating drugs that are 100% effective
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2018 Countermeasures for pandemic diseases
2023 The ultimate made-to-order medicine
Important assignment toward our vision
Copyright © 2016 Chiome Bioscience Inc. All Rights Reserved.
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 © 2016 Chiome Bioscience Inc. All Rights Reserved.
Disclaimer
32
• 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.