Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved.
Chiome Bioscience Inc.
Nov 14, 2017
Financial Results
Q3 FY12/17
Securities code : 4583
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved. 2
Agenda
◆Overview of Q3 FY12/17 “Financial results”
◆Overview of Q3 FY12/17 “Operation highlights”
◆ Others
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved. 3
Financial results: Profit and Loss(¥million)
175
1,002
489 512
▲ 827 ▲ 827
▲ 964
186
761
321
439
▲ 574 ▲ 575 ▲ 574
▲ 1,200
▲ 900
▲ 600
▲ 300
0
300
600
900
1,200
Net sales COGS / SGA R&D expenses Other costs Operating income Ordinary income Net income
3QFY12/16 Result 3QFY12/17 Result
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved.
Cash on hand and
in banks 4,352
Net assets4,525
Liabilities 184
Net assets4,565
4
Financial results: Balance Sheet
As of December 31, 2016 As of September 30, 2017(¥million)
Other non-current assets 201
Other current assets 131
Other non-current assets 72
Other current assets 128
Property, equipment and Intangible assets 35
Liabilities 224
Cash on hand
and
in banks
4,553
Property, equipment and Intangible assets 25
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved. 5
Agenda
◆Overview of Q3 FY12/17 “Financial results”
◆Overview of Q3 FY12/17 “Operation highlights”
◆Others
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved. 6
Operation highlights (1)
【Drug Discovery and Development Business Segment】
• Execution of License Agreement for LIV-1205
License Agreement with ADC Therapeutics SA (ADCT) was
concluded on September 27, 2017.
Chiome has granted ADCT a worldwide exclusive license with a
right to sublicense, develop, manufacture, and commercialize an
ADC format of LIV-1205, which is coded “ADCT-701”.
ADCT will proceed ADCT-701 to development stage.
Chiome will receive
- milestone payments when ADCT reaches each development
milestone.
- predetermined sales-tied royalty after launch.
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved. 7
• LIV-1205 (humanized anti-DLK-1 monoclonal antibody): Naked antibody
Preclinical evaluation in pediatric cancer models are ongoing under
the Pediatric Preclinical Testing Program (PPTP) funded by the U.S.
National Cancer Institute (NCI).
Chiome will continue development work on LIV-1205 towards
clinical stage to increase its product value.
Operation highlights (2)
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved. 8
Promoting in-house clinical development
ProBioGen will develop a stable GlymaxX® cell line,
followed by process development and GMP manufacturing.
About ProBioGen AG (http://www.probiogen.de/)
Founded in 1994, Germany-based ProBioGen has abundant
experience in the manufacture of investigational antibody drugs, and
possesses the GlymaxX® technology, a proprietary ADCC
enhancement platform by modification of fucose synthesis pathway
Chiome selected ProBioGen AG as a contract partner for the
manufacture of investigational drugs for clinical development.
Advancing in-house clinical development and discovery programs.
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved. 9
Operation highlights (3)
【Drug Discovery Support Business Segment】
• Efforts are made to provide better services on the collaborative and
contract R&D activity with Chugai Pharmaceutical Group as a primary
source of revenue.
• Perform antibody selections by utilizing the ADLib® system for
Mitsubishi Tanabe Pharma Corporation group.
• Launch antibody selection projects with other pharmaceutical
companies.
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved.
23%
77%
10
Operation highlights (4)
【Net sales of Drug Discovery Support (DDS)】
• Drug Discovery Support Business posted net sales of 143,716 thousand yen through 3Q.
• Sales can be broken down to Chugai Pharmaceutical Group and Mitsubishi Tanabe Pharma Corporation group etc.
【Net sales of Drug Discovery and Development (DDD)】
• Drug Discovery and Development Business posted net sales of 42,694 thousand yen through 3Q.
• Upfront payment of the License Agreement with ADCT was posted.
186
【R&D progress】
• Continuation of research activities for refining antibody discovery technology including the ADLib® system and accumulating further cases of antibody generation.
• Perform several antibody drug discovery projects focusing on cancer, immune, and central nervous system diseases. (¥ million)
DDS
DDD
Net sales
1-3Q cumulative
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved.
Development timeline and revenue model
11
Pre-clinical studies Clinical trails Launched Sale
PhaseI
PhaseII
PhaseIII
BLA
application
Approval
2~3 years 5~7 years 1~2 years
Net
sale
0
LIV-1205 ADC
LIV-2008b
Sales milestone
Royalty
BMAA
Self-development or
Licensing
Licensee
LIV-1205
LIV-2008
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved.
Project TargetTherapeut
ic area
Basic
ResearchPre-clinical studies Clinical trials Partner
LIV-1205
ADCDLK-1 Oncology
LIV-1205 DLK-1 Oncology ー
LIV-2008 TROP-2 OncologyLooking for
partners
LIV-
2008bTROP-2 Oncology
Looking for
partners
BMAA SEMA3A UndisclosedLooking for
partners
New PJ Undisclosed
Pipeline
ADCTADCT will proceed the development as ADCT-701
In-house clinical development
12
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved. 13
Profile : LIV-1205・LIV-2008/2008b
LIV-1205(Humanized anti-DLK-1 antibody)
LIV-2008/2008b(Humanized anti-TROP-2 antibody)
Target DLK-1 TROP-2
High expression
cancer
Liver cancer, lung cancer,
neuroblastoma etc.
Breast cancer (TNBC), lung cancer,
colorectal cancer etc.
Novelty of target Novel target Known target
Competitor N/A ADC (IMMU-132, Immunomedics)
Patent US,EP,CN (patent applied for JP,
others)
JP, US, CN(patent applied for EP, others)
Efficacy in
human
Unknown IMMU-132 has demonstrated clinical
efficacy
Expectation First-in-class therapeutic antibody
targeting intractable cancers
Best-in-class therapeutic antibody targeting
breast cancer (TNBC), lung cancer etc.
Naked antibody LIV-1205 exhibited a noticeable
inhibitory effect on tumor growth
using animal model in single
administration
Potent anti-tumor activity has been
observed in various cancers in single
administration of naked antibody (LIV-2008)
using animal model.
Fitness for ADC LIV-1205 has internalization activity LIV-2008b has internalization activity
TNBC: Triple-negative breast cancer
Internalization: A phenomenon that antibodies being taken into cells after binding to the antigen
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved. 14
Operation highlights (3)
【Others】
• Summary of financing status through third-party allotment
Total amount of funds (Sept. 16, 2016~Sept. 30, 2017): JPY1.7 billion
Total number of dormant stocks: 1,347
Focus on investment to bolster corporate value
14
Use of funds Cost(million JPY)Scheduled period of
spending
Development works to IND submission
and early-phase clinical development1,300 Jan. 2017~Dec. 2019
Expansion and in-licensing of new
pipelines300 Dec. 2016~Dec. 2018
Investment in/ M&A for companies with
advanced technologies for synergism1,294 Oct. 2016~Dec. 2018
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved. 15
Agenda
◆Overview of Q3 FY12/17 “Financial results”
◆Overview of Q3 FY12/17 “Operation highlights”
◆Others
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved.
Advisory board
To guarantee objectivity and transparency in management
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【Goal】To provide non-binding strategic advice based on objective assessment of
business management.
To verify and evaluate business plans and decisions both prospectively and
retrospectively.
Cl
【Member】* Shinya Fukuzaki (Lawyer)
Shiro Toba (Certified public accountant)
Jun Yoshino (Patent attorney)
*Head of advisory board
【Activity status】From May 24, 2017 though Novmber 14, 2017
Verifying our business and timely disclosure.
Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved.
Vision
Following feedback from advisory board, new
vision and business plans are going to be
discussed under new management team.
17
Copyright © 2017 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 © 2017 Chiome Bioscience Inc. All Rights Reserved.
Disclaimer
19
• 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.