briefing session regarding life sciences business - jsr.co.jp · • contract biotech api mfg...

Briefing session regarding Life Sciences business

February 21, 2018

JSR Corporation

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Agenda

• Life sciences business position in overall JSR

• JLS Direction ・strategy

• Market potential

• Business highlight

– Bioprocessing

• KBI and Selexis

• Bioprocess materials

– Drug Discovery and translational research

• Crown Bio

• Synergy between the existing businesses and Crown Bio

• Financial Target

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Life sciences business position in overall JSR JLS Direction ・ strategy

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Life Sciences business in JSR

Fine Chemicals Petrochemicals

Life sciences is the third pillar of JSR, following our petrochemicals and fine chemicals businesses

Life Sciences

Life Sciences

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Market Assessment/Opportunities:

• R and D efficiencies ($/New Molecular Entity) of major

research based Pharma were in the range of 3.2 to 32.3 BILLION dollars from 2006 to 2014

(Shuhmacher, Lassman, Hinder Journal of Translational Medicine)

• Average time to market for a new drug is 12 years (California Biomedical Research Association)

• Incredible waves of innovation, analysis tools and new

understandings of biology are yielding a much more complex landscape focused mostly on Biologics and Precision Medicine

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JSR’s Mission

Materials Innovation:

We create value through materials to enrich society, people and the environment.

Helping to bring new and better treatments to patients more efficiently and more quickly aligns perfectly with our mission. Innovation is our key component.

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JSR Life Sciences Business Focus:

Improve the probability of success, decrease timelines, and increase the

efficacy of biologics-based therapies for the benefit of patients

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Medical trend & JSR’s life science business fields

・・・

Medical trend

Personal -ized

medicine

Tailor-made medicine (Biomedicine)

From treatment

to prevention Digitalization

Companion diagnostics Genetic diagnosis

Low adverse effect

Efficiency/ effectiveness

Biomedicine

Advanced diagnosis

Early diagnosis

Bio-information monitoring

Exte

ndin

g h

ealth

y life

expecta

ncy

Health

care

cost c

ontro

l

Digital health

JSR business scope

Precision medicine

Social demands

Benefit to patients Therapeutic/

diagnostic technology

Pro

mp

t develo

pm

en

t of b

ette

r treatm

en

ts

Business field Goal

Developing business in the biomedicine and advanced diagnostic fields while incorporating changing trends in medical care

Aiming at innovative pharmaceutical development processes to swiftly provide better medical care

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JSR Life Sciences Strategy Through the entire process of creating new therapies, JSR provides services and innovative materials and tools to pharmaceutical developers, startups and academia.

4.5 Years, Success Ratio :51%, Cost : 674M$ 1Y, 69%, 150M$ 6.5 Y, 13%, 906M$

Application for approval

Analysis Process development

Manufacturing

Test in Animal Test in Human

Drug Discovery Clinical trials and application for approval

Preclinical study

Clinical trial Phase I-III

1.5Y, 91%, 48M$

Culture media Purification media and device

Screening models Stem Cell biology research

Research Tools Kits, materials and assays

Contract Development and Manufacturing Organization (CDMO)

Cell line development

Target Selection

Target Validation

Lead Identification

Lead Optimization

Candidate Validation

Bioprocessing

Contract Research Organization (CRO)

Serv

ice

Mate

rial

Pro

du

ct

Material Platform Material Platform

Analysis

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Global Site and number of employee

Global # of employee 2016: 1,360 (Actual)

2017: 1,530 (Estimate) ・・

2020： >2,400

Life sciences businesses have been expanding globally and the number of employees is expected to exceed more than 2,400 in 2020.

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Global Leadership Team

Crown Bio expects to join in June 2018.

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Market Potential

13 Market Opportunities:

Biologics will lead Pharmaceutical Growth

B US$

Precision Medicine will drive Future Drugs

Global Biologics Market Forecast – by Product (Transparent Market Research, September 2016)

Global Biologics Market Forecast – by Application

Global Precision Medicine Market Forecast – by Technology (Mordor Intelligence)

Global IVD Market Forecast – by Application

CAGR +10%

CDx is included in a part of this category as driver

“Biologics“ and “Precision Medicine” are our focus areas. These drive both the drug market (10%< CAGR), as well as continuous innovation.

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Bio CDMO Market - Expanding

• Contract Biotech API MFG market was about $4.4Bil in 2016 and is forecasted to grow at about 8% (2016-26), the same as that of the Biopharmaceuticals market.

• Though currently small in market size, significant growth is seen in next generation molecules like bioconjugates, multi-specifics, and other enhanced proteins. Cell & gene therapy is also seen as a growth opportunity.

The contract market has more growth

potential from the captive demand (in-

house) flowing into the contract space.

By Region

Source: Biological Drug API Manufacturing Services: World Industry and Market Predictions 2016-2026, visiongain 2016

CAGR = 9.7% (2016-2020) CAGR = 8.0% (2016-2026)

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Drug Discovery Outsourcing Market Forecast

in B US$ 2015 2020 2026 '15 - '20 '15-26

Total 16.6 29.6 43.7 12.3% 9.2%

CAGR

CROs Market (Drug Discovery and Preclinical) for 2009 to 2016 Source : Visiongain

CRO market Forecast

Whereas CAGR of total Pharmaceutical R&D spending is 2.6% (2009-2016), CRO revenue has grown at a CAGR of 11.5%. Pharmaceutical companies have become more dependent on CRO’s than before. The Drug Discovery Outsourcing Market will continue to grow at 9.2% of CAGR (2015-2026)

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Drug Discovery CRO market - Expanding

• For the past 8 years, Pharma has consistently invested 20% of their revenue into R&D and have steadily increased CRO utilization. They target three primary areas:

1) Outsourcing of non-core functions, such as labor-intensive, conventional analytical activities and clinical testing, so as to enable more focus on “Seed Validation” and “Pipeline portfolio management.”

2) Utilization of outside niche and specialized analytical services which are not feasible to own in-house.

3) Utilization of companies that can improve drug discovery efficiencies. Pharma now looks to these companies for innovation as well as execution.

Among CROs, competition is most severe in 1) and 2), while 3) offers the highest barriers and highest value.

This is Crown Bio’s target domain.

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Business Update: Bioprocessing

Drug Discovery Clinical trials

Bioprocessing

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JSR’s offering in Bioprocessing



Analysis Process development

Manufacturing



Preclinical study


1.5Y, 91%, 48M$

Culture media, Purification media and device


Target Selection

Target Validation

Lead Identification

Lead Optimization


Bioprocessing

Material Platform

Cell line Developer CDMO

With the addition of Selexis, JSR has acquired cell line technology so innovative that it is licensed for a drug’s development and throughout its life cycle. With KBI + Selexis, JSR now provides not only materials but CDMO services from cell line development to GMP manufacturing.

Acquired in July 2017

Analysis

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Selexis

Founded ： 2001

Acquired ： JSR acquired Selexis in June 2017

HQs ： Geneva, Switzerland (Other site：California, USA)

CEO & Founder： Igor Fisch, PhD

# of Employee：36 (as of Oct. 2017) most hold Master’s degrees or PhDs

Business ： Contract cell line (mammalian) development for biologic therapeutics

• Industry challenge: Making a high-expressing, stable cell line is complicated, but

making difficult-to-express or novel proteins can be even more challenging

• Selexis’ strength: Proprietary cell line technology that can establish a Research Cell

Bank (*RCB) in 14 weeks. *RCB: Confirmation and optimization of cell line and culture conditions and performance is high

and stable enough for in use development and high volume mfg. The earlier establishment of RCB will shorten the overall development time.

• Past record: 100 partners worldwide 80+ drug products in clinical development 3 commercial products

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Selexis

• Selexis understands the complexities of the CHO-K1 cell better than anyone having sequenced the entire genome to fully understand the mechanism of the cell.

• Advanced gene transfection technology enables the CHO-K1 cell to express more recombinant proteins

Client Case Study: 30–fold increase in Expression

Proprietary technologies

Selexis Normal CHO-K1

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Advantage of having KBI and Selexis

Cell Line Development

Integrating the Selexis and KBI processes enables dramatic time savings.

Industry standard: 12-24 months

• By integrating Selexis’ and KBI’s services, the time to IND will be reduced from 12-24 months to 9 months.

• KBI and Selexis are jointly working on >40 potential projects, of which 5 were initiated since last July, averaging 1 per month since the Selexis acquisition.

IND*

*IND: Investigational New Drug filing

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KBI Biopharma Inc. Update

Revenue Growth: • FY2016 revenue grew by 35% from FY2015. FY2017 revenue

is expected to grow by 29% from FY2016. • Launched FDA approved GMP commercial manufacturing at

Boulder, CO site (microbial process). • KBI will launch a full mammalian commercial process at its

Durham, North Carolina facility. Regional expansion: • EU analytical service lab in Belgium (KBI Biopharma BVBA in

JSR Micro NV’s new building) will start operation this spring.

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• Adoption of AmsphereTM A3 has progressed significantly. Currently 19 programs have adopted A3 for their projects, including 3 in Phase III.

• Capacity expansion at JSR Micro NV in Belgium is ongoing. The 4000L facility was completed in Dec and will be in operation this spring. With future planned capacity expansion, the total capacity will be 9,500L in 2020.

Bioprocess material: AmsphereTM A3

JSR Micro NV

A3 equivalent JSR Life Sciences Corp

(Tsukuba, Japan) JSR Micro NV

(Leuven, Belgium) Total

Current capacity 1,500L 0L 1,500L

Capacity in 2018 1,500L 4,000L 5,500L

Capacity in 2020 1,500L 8,000L 9,500L

PDF/AmsPrAJWT203.pdf

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Business Update: Drug Discovery and translational research

Drug Discovery Clinical trials

Bioprocessing

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Challenge: Lack of customer relationship





Preclinical study


1.5Y, 91%, 48M$


Research Tools Kits, materials and assays

Target Selection

Target Validation

Lead Identification

Lead Optimization


Contract Research Organization (CRO)

Serv

ice

Mate

rial

Pro

du

ct

Material Platform

Missing piece

• Significant value exists in addressing drug discovery constraints. We have some well-positioned pieces in many areas but we had a big gap in our customer relationships for drug discovery. We needed the right CRO to help close this gap.

→We acquired Crown Bio to fill the gap.

Process development Manufacturing


Bioprocessing

Analysis

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About Crown Bio

Contract service of drug seeds search and development

World-largest PDx* model collection

Contract development in the fields of oncology, inflammation,

cardiovascular and metabolic diseases

Foundation: 2006

Stock listing: Taiwan (TPEx: 6554)

Headquarters: Santa Clara, California, USA

Offices: USA (San Diego, Indiana, and Louisiana),

China (Taicang and Beijing), UK and Taiwan

CEO: Mr. Jean-Pierre Wery, PhD

No. of employees: 631 (as of Sep. 17, 2017); Approx. 40% with MSc/PhD

2018 Sales forecast: US$90 million (Our estimate)

2018 EBITDA forecast: US$20 million (Our estimate)

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Crown Bio’s offering in I/O Animal Model

PDx: Patient Derived Xenograft.

Patient-derived cancer tissues are

implanted in immuno-deficient

mouse models. These are then

used to effectively screen

anticancer agents, as assessments

can be made in an environment

closer to a human body than with

conventional methods.

Crown has variety of I/O Animal Models for different research purposes

Platform Tumor Immunity Target Therapy Property Unique utility

Xenograft tumor Hu Neg./partial Mu

Hu/Mu Hu/Mu CDX, PDX Cell therapy (e.g. CART), ADG, non-I/O

Syngeneic tumor Mu Mu Mu Mu Cell line derived MOA, surrogate POC

GEMM tumor Mu Mu Mu Mu Spontaneous, and primary, relevant path

Target therapy combo, preventative vaccine

Homograft primary tumor

Mu Mu Mu Mu “Mouse PDX”, primary relevant path

Target therapy combo

HuGEMM Mu Mu Hu Hu Partially humanized (target)

Human therapy

Xenograft/humanized Hu Hu Hu Hu huPBMC, huHSC, relevant immunity

Human therapy

Company/organization No. of PDx models

US National Cancer Ins. 1000+target

Charles River Laboratories 450＋

Novartis Pharmaceuticals 1000+

Jackson Laboratory 450＋

EurOPDX Consortium 1500+

Crown Bio 3000+

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Characteristics and Competitiveness of Crown Bio

World-largest leading edge models ・Human cancer cells + mice ・Environment closer to a

human body

Bioinformatics analysis ・Genetic information ・Protein information ・Mediator information ・Adverse effect ・Database ・AI-based analysis system

× ＝

①Analysis with models closer to human bodies

(Diversified PDx models) ②Identification and grouping of

effective and ineffective mouse models

③Identification of biomarkers Analysis of factors for effectiveness

Core technology Know-how

Efficient clinical trial planning

Companion diagnostics

Higher success rate

Pharmaceutical companies

Advanced screening and analysis services Contract development

Valuable analysis results

Combination of the world’s largest collection of diversified PDx models, other leading-edge innovative animal models and bioinformatics analysis technology enhances the clinical trial success rate, streamlines clinical trial planning, and contributes to the effective development of biomarkers/companion diagnostics.

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Crown Bio as the commercialization platform

Crown Bio will effectively work as the commercialization platform of JKiC Research, JSR Life Sciences and MBL’s products (existing and developing).

Bio markers can be commercialized to CDx with MBL’s capabilities and will contribute to making Precision Medicine a reality.

Drug Discovery

(antigens, antibodies and monitoring tools, etc.)

Ex. MHC Tetramer

Biomarker

Companion diagnostics

Ex. Organoid, Cancer Stem cells


Research Tools, Kits, Material, Assays

Target Selection Target Validation Lead Identification Lead Optimization Candidate Validation

Identify Target considering; -Efficacy -Safety -Clinical/Commercial Needs Based on Publications, IP, Gene Expressions, Proteomics data etc.

In Vivo Efficacy Assays -Tumor Models -Chimeric Model -Humanized Model -Xenograft Model -PDX Model

Experimentally Validate Target by ; -Cell line Model -Animal Model -Syngeneic Models

-Select Antibody Type -Prepare In vitro Screening model -Develop several Assays

Antibody Design/Improve in; -Humanization -Fc Engineering -expression, stability, aggregation, Glycosylation -Explanatory PK/PD

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What enables us to serve - our core competences

• JSR R&D JSR Materials R&D will continuously enable the creation of unique value propositions and must also

continue to evolve as new technologies and trends are integrated (biology, informatics, etc.)

• Innovation Engine Innovation is our Engine. We not only drive Innovation internally, but we also have the organizational mindset to apply new technologies and business models – the ability to recognize, absorb, integrate and commercialize new ideas.

• Customer-centric Clearly Contract Services must differentiate on Customer Support. Customer relationships are at the core of our corporate DNA.

• Quality and Disciplined Manufacturing Systems Quality is first. We have a quality conscious mindset in all we do, as evidenced by our highly Disciplined approach to manufacturing systems and processes.

• Global Expertise We are truly multicultural. We have expertise and access to both the Western (high technical intensity) and Eastern (high barrier to entry) markets.

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Example of JSR’s technology in action

Antibody Generation

Organoid

Y Y Y Y

Culture Media Recombinant Protein Synthetic GF

Scaffold Gel Materials Cell printing

Informatics Culture Condition Simulation, Genomics

Cell mutation Genetic recombination

Drug Dev Drug Disc Effectivity Toxicity

Antibody Marker Antibody CHO cell Modification

Cell Culture development by Chemistry, Life Sciences and Informatics

Cell Engineering Collaboration with JKiC, JSR R&D activities:

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JSR LS Business Focus:

Improve the probability of success, decrease timelines, and increase the

efficacy of biologics-based therapies for the benefit of patients

With Innovation as our Engine and

Customer Relationships as our fuel, we will thrive in this market

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Financial Target of Life Sciences Business

Diagnostic drug

CDMO

Cell Line Development

Unit: Oku yen

Drug discovery support

JSR’s material development, in combined with the acquisition of MBL, KBI Biopharma and Selexis, results in forecast sales for the Life Science Business of 500 Oku yen in the fiscal year ending March 31, 2020.

The acquisition of Crown Bio will increase our ability to achieve our goals as we aim at JPY1,000 Oku yen in the long term.

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Self-Drug

Development

Materials IVD Contract Services

Pre-Clinical CRO Cell Line Analytical/PD/GMP mfg

☑ Research

Reagents -- ☑ ☑ ☑

-- Research

Reagents -- ☑ ☑ ☑

☑ Research Reagents and IVD

kits and consumables -- ☑ ☑

-- Consumables

for IVD/Medical

Imaging system

Genetic Dx

and other Dx

Imaging base pre

Clinical CRO -- --

☑ DNA synthesis

beads -- -- -- Cont-mfg of Nucleic Acid

synthesis

☑

Chemicals for

Drug law

materials -- -- ☑ ☑

--

JLS product/service lines - comparison with others

Wuxi Biologics Wuxi AppTec

Fujifilm

KONICA MINOLTA

Niito

AGC

charles river

* The forecasts, future plans and strategies made in this document contain a variety of uncertain factors, since it has been prepared based on judgments from currently available information. Actual business results may differ from those projected, depending on factors such as the economic status of the market surrounding the company.

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briefing session regarding life sciences business - jsr.co.jp · • contract biotech api mfg...

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