COMPANY RESEARCH AND ANALYSIS REPORTGene Techno Science Co.,Ltd.
4584
TSE Mothers

30-Aug.-2018
FISCO Ltd. Analyst

Yuzuru SatoFISCO Ltd.
http://www.fisco.co.jp

COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html■ Index■Summary---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 01
1. Overview of the FY3/18 results....................................................................................................................

01

2. Movements in the development pipeline......................................................................................................

01

3. The business strategy for the future....... ......................................................................................................

02

4. Results outlook............................................................................................................................................

02■Company profile---------------------------------------------------------------------------------------------------------------------------------------------------------- 03
1. History................................................... ......................................................................................................

03

2. Biologics and biosimilars.............................................................................................................................

05

3. The biologics market scale..........................................................................................................................

07

4. Business model...........................................................................................................................................

10■Status of the development pipeline---------------------------------------------------------------------------------------------------------- 12
1. Biosimilars business....................................................................................................................................

12

2. New biologics business......................... ......................................................................................................

14

3. New biotech business. . ................................................................................................................................

15■Results trends--------------------------------------------------------------------------------------------------------------------------------------------------------------- 16
1. Overview of FY3/18 results.................... ......................................................................................................

16

2. FY3/19 outlook...................................... ......................................................................................................

16

3. Financial position and fund raising. . ....... ......................................................................................................

17■The business strategy for the future------------------------------------------------------------------------------------------------------- 19

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
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Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html██SummaryHas in sight the market launches of multiple pipeline development
drugs and has started measures toward further business expansion
Gene Techno Science Co.,Ltd. <4584> (hereafter, also “the Company”) is a drug discovery bioventure originatingfrom Hokkaido University. It specializes in biologics and biosimilars, and it was the first company in Japan to market
launch a filgrastim biosimilar from among all the biosimilars launched in accordance with the Japanese biosimilar
guidelines. In 2016, it became a group company of Noritsu Koki Co., Ltd. <7744>, and it is also entering the field of
regenerative medicine as a new biotech business, following its biosimilar and new biologic businesses. It is aiming
to be an engineering company that creates value in the bio field.
1. Overview of the FY3/18 results
In the FY3/18 results, net sales decreased 2.7% year-on-year (YoY) to ¥1,059mn and the operating loss was ¥913mn(compared to a loss of ¥1,184mn in the previous fiscal year). Net sales were basically as forecast, with sales of thefilgrastim BS (biosimilar) increasing 3.6% to ¥852mn, and in addition, revenue from intellectual property rights, etc.,
rising 41.1% to ¥121mn. In terms of costs, R&D costs declined, down 22.7% to ¥1,107mn, which was the main
reason for the reduction in the operating loss. For the progress made in the development pipeline, the biosimilarin the ophthalmology field (an age-related macular degeneration therapeutic agent) that the Company is jointly
developing with Senju Pharmaceutical Co., Ltd., started phase 3 clinical trials in November 2017. Also, for the new
biotech business, it established Minerva Medica Co., Ltd. (in May 2017), and it has started joint research throughthe Company for a treatment for diabetic nephropathy using autologous bone marrow mesenchymal stem cells,
which is being researched by Sapporo Medical University.
2. Movements in the development pipeline
Looking at the main movements in the development pipeline in the biosimilar business, the phase 3 clinical trialsof darbepoetin alfa BS (a renal anemia therapeutic agent) are being progressed by its joint-development partner
Sanwa Kagaku Kenkyusho Co., Ltd. They are expected to be completed during 2018, with the aim of applying for
manufacturing and sales approval during FY3/19 and then a domestic market launch in the first half of 2020. Also,
the phase 3 clinical trials of the biosimilar in the ophthalmology field will be completed around 2020 and the goal
is to market launch it during 2021. Overseas also, the Company intends to conclude various agreements during
FY3/19, while it is also aiming to acquire manufacturing and sales approval for the PEG-filgrastim BS in the 2020s.

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Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

Summary

3. The business strategy for the future
In the biosimilar business from 2020 onwards, the Company has in sight the market launches of multiple pipeline
biosimilars, while it has indicated that its policy is to achieve further growth by working to develop the new biologics
business and a new biotech business that will be centered on the regenerative medicine field. It also intends toexpand the fields it targets to pediatric diseases, in addition to the previously targeted fields of intractable andrare diseases. For new biologics, the Company is conducting licensing-out activities for GND-004 targeting theophthalmic diseases and cancer fields, while it also progressing joint development with academia for multiple
development candidate drugs. In addition, in the regenerative medicine field, its joint-research partner, Japan
Regenerative Medicine Co., Ltd., is conducting clinical trials on cell therapy for childhood congenital heart diseaseusing intra-cardiac stem cells, toward a market launch in Japan during the 2020s at the earliest, while it also plans
to progress its development for the markets in Europe and the United States.
4. Results outlook
The forecasts for FY3/19 are for net sales to be around the same level YoY, at ¥1,060mn, and an operating loss of¥1,180mn. Sales of filgrastim BS are expected to be the same as in the previous fiscal year, while the higher R&D
costs will cause the operating loss to increase. So the operating loss is expected to continue for the time being
due to the upfront investment in R&D costs, but the Company will enter a sales-growth phase from around 2021
onwards, which is when the ophthalmology-field biosimilar is scheduled to be market launched. So it has in sightbecoming profitable in the near future.
Key Points
A bioventure originating from Hokkaido University that is a pioneer in biosimilar development in Japan
Following on from the biosimilar and new biologics businesses, is starting measures for a new biotech business(regenerative medicine field) as its third business• Expected to achieve operating profit during the 2020s following the scheduled market launches of multiple
biosimilars••

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Source: Prepared by FISCO from the Company’s financial results

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
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Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html██Company profile
A bioventure originating from Hokkaido University that is a pioneer
in biosimilar development in Japan
1. History
The Company is a bioventure company that was established within Hokkaido University in 2001 with the objectiveof developing diagnostic and therapeutic agents based on the research of the University’s Division of MolecularInteraction in the Institute for Genetic Medicine. In terms of research and development of new biologics, it licensedout the anti-integrin alpha 9 antibody to Kaken Pharmaceutical Co., Ltd. <4521> in June 2007, and currently
also it continues to advance its R&D. The Company also began developing biosimilars in order to build a stableearnings foundation. In 2007, it entered into a joint-development agreement with Fuji Pharma Co., Ltd. <4554>
for a filgrastim* biosimilar, and in November 2012, it was the first company to obtain approval for manufacturing
and sales for a biosimilar under Japan’s biosimilar guidelines. This product has been marketed by Fuji Pharma andMochida Pharmaceutical Co., Ltd. <4534> since May 2013. The Company was listed on the Tokyo Stock Exchange(TSE) Mothers market in November 2012.
* Filgrastim: a granulocyte growth factor drug product (G-CSF). Following chemotherapy (dosages of anti-cancer agents), white blood
cells decrease and immunity is weakened (called neutropenia), causing various symptoms, and filgrastim is used to treat this. The
innovator drug is Gran by Kyowa Hakko Kirin Co., Ltd. <4151>.

Whilst strengthening its biosimilar development pipeline, the Company has been actively forming partnerships withother companies for joint developments. It entered into an agreement with Sanwa Kagaku Kenkyusho for the joint
development of darbepoetin alfa BS in January 2014, then it concluded basic agreements for joint development
and sales with Mochida Pharmaceutical in the oncology field in August 2015 and with Senju Pharmaceutical in theophthalmology field in November of the same year, and they are progressing the joint development of each.
Also, in 2016, the Company conducted a capital participation in NK Relations Co., Ltd, which is a member of the
Noritsu Koki Group (hereafter, also “the NK Group”), and it became a member company of this Group. It concluded
a capital and business partnership agreement with Japan Regenerative Medicine, which is also a member of the
NK Group, and it is advancing developments in the regenerative medicine field, which is building the footholds fora new biotech business. In addition, the Company concluded a capital and business partnership agreement with
JSR Corporation <4185>, and in 2017, it entered into a capital and business partnership agreement with ITOCHUCHEMICAL FRONTIER Corporation for the joint development of a second biosimilar development drug (it received
a capital investment for the first drug in 2013). Then in April 2018, it concluded a capital and business partnershipagreement with NanoCarrier Co., Ltd.<4571>, and each partner company is a major shareholder of the Company.

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

Company profile

History
Date

Major event

March 2001

Established in Sapporo with the objective of developing diagnostic and therapeutic agents based on the research of the Divisionof Molecular Interaction, Institute for Genetic Medicine, Hokkaido University

June 2002

As a bioventure certified by the National Institute of Advanced Industrial Science and Technology (AIST), it newly establishedresearch facilities within the Hokkaido Center of AIST and reinforced its research and development into new biologics

June 2007

Licensed-out the anti-integrin alpha 9 antibody to Kaken Pharmaceutical Co., Ltd.

October 2007

Entered into a joint-development agreement with Fuji Pharma Co., Ltd. for a filgrastim (G-CSF) biosimilar

January 2008

Licensed-in a filgrastim biosimilar cell line and basic production technology from Dong-A Pharmaceutical Co., Ltd.

November 2012

Fuji Pharma Co., Ltd. and Mochida Pharmaceutical Co., Ltd. domestically acquired manufacturing and sales approval for thefilgrastim biosimilar (launch in May 2013)

November 2012

Listed on the Tokyo Stock Exchange (TSE) Mothers (market of the high-growth and emerging stocks)

August 2013

In the biosimilar business, entered into a capital and business partnership with ITOCHU CHEMICAL FRONTIER Corporation

January 2014

Entered into a joint-development agreement with Sanwa Kagaku Kenkyusho Co., Ltd., for a darbepoetin alfa biosimilar

June 2014

Entered into a nucleic-acids joint business agreement with Gene Design Inc. with the objective of commercializing a nucleic-acid
pharmaceuticals platform

November 2014

Entered into a capital and business partnership with ORTHOREBIRTH Co., Ltd., which is conducting research and development
on synthetic bones

August 2015

Entered into a basic agreement for a business partnership with Mochida Pharmaceutical Co., Ltd. toward the joint development
and sales of a biosimilar in the anti-cancer field (concluded an agreement to launch a joint business in December 2016)

November 2015

Entered into a basic agreement for a capital and business partnership with Senju Pharmaceutical Co., Ltd. toward the joint
development and sales of a biosimilar in the ophthalmology field (concluded an agreement to launch a joint business in May 2016)

March 2016

Entered into a capital and business partnership agreement with NK Relations, a group company of Noritsu Koki (became a Groupsubsidiary in June 2016)

October 2016

Entered into a capital and business partnership agreement with Japan Regenerative Medicine, a group company of Noritsu Koki

December 2016

Entered into a capital and business partnership agreement with JSR Corporation

February 2017

Entered into a joint R&D agreement with Juntendo University for immunological tolerance induction

March 2017

Entered into a capital and business partnership agreement with ITOCHU CHEMICAL FRONTIER Corporation for the joint
development of a second biosimilar

May 2017

Together with AIN HOLDINGS Inc., and others, the Company established Minerva Medica with the aim of starting a stem celltherapy business (investment ratio, 25%)

April 2018

Entered into a capital and business partnership agreement with NanoCarrier

Source: Prepared by FISCO from the securities report and press releases

Developments in capital and business partnerships
Company nameObjective of the capital and business partnership

Japan
Regenerative
Medicine

Toward launching a business for the first time in the world of regenerative medical products that utilize intra-cardiac stem cells,
which are being developed by Japan Regenerative Medicine, the companies will utilize the expertise in biologics development that
the Company has accumulated and steadily work to launch a business for regenerative medical products at an early stage. In
addition, synergies are expected with the new biotech business that the Company will develop.

JSR

By combining the management resources of both companies, the aim is to strengthen the Company’s biologics business and
JSR’s life science business. Specifically, for the development of the drugs in the Company’s development pipeline, KBI (a biologics
development and manufacturing outsourcing company), which is a subsidiary of JSR in the United States, has been positioned
as one manufacturing outsourcing candidate, and it will develop and construct the manufacturing process. Also, in the process ofdeveloping the manufacturing process, it will actively investigate the bio-process materials, including the refining agents and otherproducts being developed by JSR, and it will cooperate in the development of the bio-process materials. The aim is that in the
future, the Company’s biologics will be utilized at the time of commercial production.

NanoCarrier

The goal is to make use of each company’s respective strengths, of NanoCarrier's micellar nanoparticle technologies, theCompany's biologics drug discovery technologies, and the NK Group's regenerative medicine business, to create new therapeutic
products and also to advance excellent bio-technologies toward launching a global business.

Source: Prepared by FISCO from the Company press releases

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

Company profile

Possesses the leading expertise within Japanfor the development of biosimilars
2. Biologics and biosimilars
The biologics developed by the Company refer to pharmaceuticals that are manufactured utilizing the ability of
microorganisms or cells to create specific proteins (such as hormones, enzymes, and antibodies) that are useful for
pharmaceuticals. As it involves creating pharmaceuticals using the proteins that are originally present in the human
body, a strength of biologics is that they are kind to the human body, and antibody pharmaceuticals, which are one
type of biologics, have a lower risk of side effects as they act directly on the diseased or affected area. Well-known
biologics include insulin (a diabetes therapeutic agent) and interferon (a hepatitis C therapeutic agent).
General pharmaceuticals (small molecule drugs) are mass-produced by chemosynthesis on a molecular level. But incontrast, biologics utilize gene recombination technologies and cell culture techniques to synthesize microorganisms
and cells in large volume, and therefore major costs must be undertaken for their development and the manufacturing
facilities for their mass production. They also tend to have shorter expiry periods than small molecule drugs, leading
to higher product prices.
In the same way that general pharmaceuticals have innovator drugs, which are the drugs that were developed first
and then followed by generic pharmaceuticals that use the same molecules as these innovator drugs, biosimilars
are the follow-on products of biologics. In the case of biosimilars, the drug efficacy and safety do not change
compared to the innovator drug because the type of protein is the same as that in the innovator drug. However,the sugar chain attached to the protein is slightly different, so biosimilars are not identical to their innovator drugs.
Therefore, in order to demonstrate the similarity between the innovator drug and the biosimilar, it is necessary toestablish an independent manufacturing process and to accumulate physicochemical data to prove their similarity.
It is also necessary to conduct clinical trials to prove the biosimilar’s safety and efficacy. Approvals are given basedon meeting these requirements, and therefore the R&D costs of biosimilars are much higher than those of genericpharmaceuticals.
As the drug price of biosimilars are set at around 70% of the prices of the innovator drugs, high productivity in thedevelopment and manufacturing process are important for the commercialization of biosimilars. In particular, there are
not many companies in Japan that possess the expertise necessary to establish the required manufacturing process
or to analyze the characteristics and the quality levels of the developed biosimilars. The Company specializes inbiologics and biosimilars and has accumulated a track record in this field from conducting research and development
for more than 10 years, establishing its position as the leading expert for the development of biologics and biosimilars
in Japan.

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
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Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

Company profile

When comparing new biologics and biosimilars, the period of time from the start of research to market launch is
16 to 17 years for a new biologic, but only 6 to 8 years for a biosimilar. In the case of a new biologic, it takes 2 to 3
years to search for the gene (functional analysis) and 2 to 4 years to screen the drug candidate compounds. It also
takes a long time from the start of the non-clinical trials to the end of the clinical trials. Therefore, the scale of the
R&D costs is ¥20bn to ¥30bn for a new biologic, but only ¥5bn to ¥10bn for a biosimilar. Moreover, the probabilityof success, from development through to market launch, is considerably higher for a biosimilar compared to a
new biologic. So for a bioventure like the Company, it can be said that the biosimilar business is a field with highdevelopment efficiency.
Characteristics of biologics· Biologics refers to the application of gene recombination, cell culture and other technologies and techniques, and the utilization of the ability of
microorganisms or cells to create proteins for the mass production and commercialization of specific proteins (including hormones, enzymes, andantibodies) as pharmaceuticals.
· The main biologics include insulin (a diabetes therapeutic agent), interferon (a hepatitis C therapeutic agent), and adalimumab (a rheumatism andpsoriasis therapeutic agent).

Biologics

General pharmaceuticals

Size (molecular weight)

Approx. 10,000~

100~

Manufacturing method

Synthesized within microorganisms and cells

Chemosynthesis

Unstable (the product can change depending on theconditions of the microorganisms and cells)

StableProduction

Explanation of biosimilars
Biosimilars are pharmaceutical products that have demonstrated the equivalent efficacy and safety compared to previously approved biologics throughclinical trials.

Differences between biosimilars and other generic pharmaceuticals
Biosimilars

Other generic pharmaceuticals

Molecular structure

Large and complex

Small and simple

Efficacy and safety

Substantially the same as innovator drug
(Amino acid sequence is the same, but aspects such as
the molecular structure and manufacture process differ)Same as innovator drug(Same molecular array, same structure)

Development cost andmanufacturing equipment
costHigh (¥20–30 billion)* Innovator drug: ¥100 billion

Low (around ¥0.1 billion)* Innovator drug: ¥30–¥100 billion

Price difference against
innovator drug

70% of innovator drug price* 60% for oral drugs when more than 10 biosimilarsof a specific innovator drug are launched

60% of innovator drug price* 50% for oral drugs when more than 10 genericproductsof a specific innovator drug are launched

Source: extracted from “Current conditions of biosimilars” by the Ministry of Health, Labour and Welfare (July, 2014)

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
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Gene Techno Science Co.,Ltd.

30-Aug.-20184584 TSE Mothers

http://ir.g-gts.com/en/Top.html

Company profile

The scale of the biologics market is growing by 8% annually andis forecast to be worth US$300bn by 2021
3. The biologics market scale
The biologics market continues to grow year by year, and in 2016 it was worth around US$202bn, meaning it
accounted for about 25% of the global pharmaceutical market that is worth approximately US$803bn. Goingforward, the pharmaceutical market as a whole will continued to grow by 5% annually, but the biologics market
is expected to achieve higher growth, of 8%. By 2021, it is evaluated that it will have grown in scale by 1.5 times
compared to 2016, to be worth around US$302bn. Also, one of the features of biologics is that a high percentageof them are large-scale pharmaceuticals, and on looking at the sales ranking of pharmaceuticals in 2016, we seethat 7 of the top 10 products were biologics.

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Note: Figures from 2017 onwards are estimates and forecasts
Source: Prepared by FISCO from various materials

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Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

Company profile

Large-scale pharmaceuticals’ global net sales (2016)
Rank

Product
nameGeneric nameMedicinal effect

Manufacturer

Net sales(US$mn)Patent expiry year

1

HumiraAdalimumab

Rheumatism / psoriasis

AbbVie / Eisai

16,515

United States (2016)
Europe (2018)2

EnbrelEtanercept

Rheumatism / psoriasis

Amgen / Pfizer / Takeda

9,248

United States (2028)
Europe (2015)

3

Harvoni

Sofosbuvir + Ledipasvir

Hepatitis C

Gilead Sciences

9,081

4

Remicade

Infliximab

Rheumatism /Crohn's Disease

J&J / Merck /Mitsubishi Tanabe

8,070

United States (2018)
Europe (2015)5

LantusInsulin glargine

Diabetes

Sanofi

8,027

United States (2014)
Europe (2014)

6

RituxanRituximab

Anticancer agent /lymphoma

Biogen / Roche / Chugai

7,482

United States (2016)
Europe (2013)

7

Revlimid

Lenalidomide

Multiple myeloma

Celgene6,974

8

AvastinBevacizumab

Anticancer agent /colon and breast

Genentech / Roche / Chugai

6,885

United States (2019)
Europe (2022)

9

Herceptin

Trastuzumab

Anticancer agent /breast cancer

Genentech / Roche / Chugai

6,884

United States (2019)
Europe (2014)10

Januvia

Sitagliptin

Diabetes

Merck

6,440

Note: Figures in red are biologics
Source: Prepared by FISCO from Evaluate Pharma2017

In this situation, the global market scale of biosimilars in 2016 was around US$1.6bn, and while the Japanese market
is still small at approximately ¥18.4bn, it is forecast to grow rapidly in the future. This is because the patents of thebiologics that currently rank top for sales will expire one after another up to 2020, so it will become possible to sellthem as biosimilars. In the biosimilar market, since the launch of sales of a human growth hormone preparation in
Europe in 2006, the EU has approved 41 products in 13 categories, while Japan has approved 18 products in 8
categories and the United States 14 products in 11 categories. In particular, the number of approved products has
been increasing in the United States since 2016, following its publication of biosimilar guidelines in 2015. In regions
outside of Japan, Europe, and the United States also, in many cases it is possible to obtain approval if the producthas been approved by two of either Japan, the United States, or Europe.

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
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Gene Techno Science Co.,Ltd.

30-Aug.-20184584 TSE Mothers

http://ir.g-gts.com/en/Top.html

Company profile

Biosimilars approved in Japan, the US and Europe
Number of approved products
Generic name

Disease indicated forEuropeUnitedStatesJapan
2

InsulinDiabetes

3

1

Insulin lispro

Diabetes

1

1-

Somatropin

Growth hormone preparation

1

1

1

Teriparatide

Osteoporosis

2

-

-

Epoetin

Renal anemia

5

1

1

Filgrastim

Neutropenia in cancer chemotherapy

8

1

5

PEG-filgrastim

Neutropenia in cancer chemotherapy

-

1

-

Follitropin alphaOvulation inducing agent

2

-

-

Infliximab

Rheumatism, Crohn's disease

4

3

5

Adalimumab

Rheumatism, psoriasis

4

2

-

Rituximab

Anticancer agent / lymphoma

6

-

1

Bevacizumab

Anticancer agent / colon and breast

1

1

-

Trastuzumab

Anticancer agent / breast cancer

3

1

2

Etanercept

Rheumatism, psoriasis

Total

1

1

1

41

14

18

Source: prepared by FISCO from materials from the National Institute of Health Sciences㻺㼡㼙㼎㼑㼞㻌㼛㼒㻌㼎㼕㼛㼟㼕㼙㼕㼘㼍㼞㼟㻌㼍㼜㼜㼞㼛㼢㼑㼐㻌㼎㼥㻌㼞㼑㼓㼕㼛㼚㻱㼡㼞㼛㼜㼑

㻝㻤㼁㼚㼕㼠㼑㼐㻌㻿㼠㼍㼠㼑㼟

㻶㼍㼜㼍㼚
㻝㻢

㻝㻢
㻝㻠
㻝㻞
㻝㻞
㻝㻜
㻤
㻢
㻡

㻢
㻠

㻠

㻠

㻠

㻠

㻟

㻠

㻟

㻞
㻞

㻞

㻝

㻝

㻝

㻝

㻜
㻞㻜㻜㻢㻌㻙㻌㻞㻜㻝㻞

㻞㻜㻝㻟

㻞㻜㻝㻠

㻞㻜㻝㻡

㻞㻜㻝㻢

㻞㻜㻝㻣

㻞㻜㻝㻤

Note: Results for 2018 are up to June
Source: prepared by FISCO from materials from the National Institute of Health Sciences (June 2018 survey)

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09 21

COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

Company profile

It is said that the spread in the use of biosimilars will become the trump card in keeping down medical expenses,
which are increasing year by year. This is because while demand for biologics is growing every year due to their highmedicinal efficacy, there is also the aspect of the pressure to keep down government medical expenditure due totheir high drug prices. As the prices of biosimilars are about 70% of their innovator drugs, the spread in the use ofbiosimilars will have a major effect in keeping down medical expenses. However, although the Japanese governmentis advancing revisions to the dispensing fee system to raise-up the usage rate of generic drugs, it is not targetingbiosimilars for these revisions, so the current situation in Japan is that the speed of their spread is low compared
to in Europe. Therefore, in June 2017 the Japanese government announced a Cabinet resolution, that it would“supplement the policies to support biosimilar R&D with the aim of doubling the number of approved biosimilars by
fiscal 2020,” thereby setting out its policy of promoting the spread in the use of biosimilars within Japan. This policy
can be expected to prove beneficial for the Company.
The Company has only a few domestic competitors for biosimilars that carry out cell line construction and drug
manufacturing, including JCR Pharma Co., Ltd., <4552> and FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd., which
is a joint-venture company of Kyowa Hakko Kirin Co., Ltd., and Fujifilm Corporation.

Following on from the biosimilars and new biologics businesses, hasstarted measures for a new biotech business (regenerative medicine
field) as the third business
4. Business model
A feature of the Company’s business model is the deployment on a virtual business structure of a biosimilar businessthat is highly stable and that can become profitable an early stage, and a new biologics business for which theaim is high growth. Also, since joining the NK Group in 2016, it has started measures for a new biotech business,
including for the regenerative medicine field, as its third business.
Business model

Source: Company website

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10 21

COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

Company profile(1) Biosimilars business
The earnings model for the biosimilar business is comprised of sales from earnings at the R&D stage and thepost-market-launch stage from supplying the drug substance that will be the main raw material for the drug
product developed by the pharmaceutical company that is collaborating with the Company. Earnings are also
comprised of agreement upfront payments and milestone payments that depend on the progress made in the
non-clinical and clinical trials. The Company outsources all of the tasks that are the sources of earnings in thebiosimilar business, of the manufacturing, analysis, and evaluation and other testing of the drug substance.
As an example, for the market-launched filgrastim biosimilar, the Company paid royalties to license-in the cellline from Dong-A Socio Holdings (formerly, Dong-A Pharmaceutical Co. Ltd.) of South Korea, it developed thedrug substance and the manufacturing process for its commercial production, and it sells the developed drug
substance to its partner, Fuji Pharma. Fuji Pharma manufactures and sells the drug product, and it also supplies
the drug product to Mochida Pharmaceutical. The filgrastim biosimilar developed by the Company accounts forapproximately 30% of the filgrastim sales in Japan since sales started in 2013, and this ratio is expected to riseeven further in the future. Filgrastim biosimilars are sold by a number of pharmaceutical manufacturers other thanFuji Pharma and Mochida Pharmaceutical, including Nippon Kayaku Co., Ltd. <4272>, Takeda Teva PharmaCo., Ltd., Sawai Pharmaceutical Co., Ltd. <4555>, and Sandoz Co., Ltd. However, it seems that in Japan, theproducts of Fuji Pharma and Mochida Pharmaceutical, which hold the phase 3 clinical trial data, have the highest
shares of the market.
(2) New biologics business
The Company implements its new biologics business from the basic research for drug discovery. It conducts
research not only in-house, but also jointly with universities and other research institutes. Manufacturing, quality
testing, and non-clinical trials for the discovery of drug candidates are outsourced to CROs both domesticallyand overseas. As enormous costs will be subsequently incurred at the clinical trials stage, in principle its basic
policy is to license-out the candidate to a pharmaceutical company at this stage.
Therefore, as its earnings model, the Company mainly enters into joint research and development agreements orlicense agreements and obtains earnings from agreement upfront payments, milestone payments depending on
the progress made in the development, and then from royalties after the product is launched.
In terms of its licensing-out track record, in 2007 the Company provided the exclusive development, manufacture, and sales rights of an anti-integrin alpha 9 antibody (immune diseases and cancer diseases) to Kaken
Pharmaceutical. Also, for the other drugs in its development pipeline, it is advancing joint research with academia
and others in fields including cancer, immune diseases, and circulatory diseases, based on the keywords ofintractable and rare diseases and pediatric diseases.

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11 21

COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html██Status of the development pipeline
Has in sight the market launches of multiple pipeline biosimilars
from 2020 onwards
1. Biosimilars businessCurrently, within the biosimilar products that the Company has already launched or is currently developing, thepotential markets for the main 7 products have been provisionally calculated to be ¥1.456 trillion globally andeven ¥115bn for Japan alone (innovator sales × 60% as biosimilar volume penetration rate × 70% of the innovator
drug price). Within these, for filgrastim BS, which it has already launched on the domestic market, the Company
is achieving sales of around ¥90mn a year through sales of the drug substance, mainly to Fuji Pharma, and going
forward also, these steady sales are expected to continue.
Other drugs within the development pipeline for which the Company has entered into a joint development agreement
and that are currently being developed are the three products of GBS-011 (darbepoetin alfa), GBS-007 (biosimilarin the ophthalmological field), and GBS-005 (adalimumab). Also, although net yet announced, it seems that theCompany has decided on the joint-development partner for GBS-010 (PEG-filgrastim). The current status of andfuture outlook for each pipeline drug is described below.
(1) GBS-011
GBS-011 is a biosimilar of darbepoetin alfa (product name: Nesp / Aranesp), which is a renal anemia therapeutic
agent, and current its phase 3 clinical trials are being conducted by Sanwa Kagaku Kenkyusho, the Company’s
joint-development partner, with the aim of applying for manufacturing and sales approval in around 2018. As it
takes more than a year from the time of application until the approval, if the approval review goes smoothly, it isexpected to be market launched in around 2020. This product is manufactured by Dong-A ST of South Korea,
while the Company is conducting joint development in the form of supporting the development by Sanwa Kagaku
Kenkyusho. It will receive royalties after it is market launched, depending on the sales.
(2) GBS-007
GBS-007 is a biosimilar in the ophthalmology field for an age-related macular degeneration therapeutic agent, andcurrently Senju Pharmaceutical, the Company’s joint-development partner, is conducting the phase 3 clinical trials.
These trials are scheduled to finish around 2020, and the aim is to acquire manufacturing and sales approval andmarket launch it in around 2021. In terms of age-related macular degeneration therapeutic agents in Japan, twobiologics, Ranibizumab (product name: Lucentis) and Aflibercept (product name: Eylea) are administered, andRanibizumab’s net sales are about ¥23bn, and Aflibercept’s about ¥60bn. Therefore, the potential demand for abiosimilar of age-related macular degeneration therapeutic agents is provisionally calculated to be approximately¥35bn for Japan.
In the global market, Ranibizumab’s sales are approximately ¥350bn and Aflibercept’s about ¥700bn, so if abiosimilar for both products can be sold domestically and overseas, the potential in terms of improving results isenormous. For the development of biosimilars in the ophthalmology field, overseas, Samsung Bioepis and one
other company are conducting phase 3 clinical trials, but there is no other company in Japan doing so, so if thedevelopment is a success, the extent of its contribution to results is expected to be great.

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

Status of the development pipeline(3) GBS-005
GBS-005 is a biosimilar of adalimumab (product name: Humira) which is the world’s top selling drug (sales of¥1.7 trillion in 2016) as a therapeutic agent for rheumatoid arthritis and psoriasis. As the size of the market foradalimumab is so large, the competition to develop biosimilars for it is also fierce, and already in the markets in
Europe and the United States, 6 products have been approved since 2016. Therefore, the Company is searchingfor partners for GBS-005 for the Asian market, including in China.
(4) GBS-010
GBS-010 is a biosimilar of PEG-filgrastim (product name: G-Lasta / Neulasta) that reduces the frequency of drug
administration and increases the sustainability of the drug’s effects by modifying PEG (polyethylene glycol) with filgrastim. The non-clinical trials have already been completed, and in addition, although it has not been announced,
the Company has decided on the joint development company and is aiming to start the phase 3 clinical trials by
2020. PEG-filgrastim BS is based on the raw material of filgrastim BS, which has already been marked launched,
and this is considered to be an advantage for the Company in terms of progressing its development. The plan isto advance its development so that it can be launched without delay around the fall of 2022, which is the time ofthe expiration of the innovator drug’s re-review period. Also, there are many interested companies in Asia, so it ispossible that this will lead to a joint development agreement in the future.
(5) Others
In terms of the other pipeline biosimilars, GBS-004 (generic name: bevacizumab, product name: Avastin) and
GBS-008 (generic name: palivizumab, product name: Synagis) are still at the research-and-development stage.
Within them, the Company is searching for a Chinese company to be a partner for GBS-008, which is an infant
infection therapeutic agent.
As its biosimilar pipeline, the Company plans to progress the development of another 1 or 2 products. The aim
is to market launch these new pipeline biosimilars around 2025.

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

Status of the development pipeline

Main biosimilars in the pipeline
Pipeline (generic name)

Biosimilars’ potential
market scale

Innovator drug and product name(indication)

Japan

Progress

Partner

The world

GBS-001(filgrastim)

Gran/Neupogen (biologics forneutropenia caused by chemotherapy)

¥8bn

¥40bn

Market launcheddomestically.

Fuji Pharma, MochidaPharmaceutical

GBS-004(Bevacizumab)

Avastin (anticancer drug)¥37bn¥250bnUnder development
research-

GBS-005(adalimumab)

Humira (biologics for rheumatoid
arthritis)¥14bn¥720bnUnder development
research

Conducting licensingout activities

GBS-007(ophthalmic biologics)

Ophthalmic biologics age-related
macular degeneration, etc.

¥10bn

¥87bn

Phase 3

Senju Pharmaceutical

GBS-008(palivizumab)

Synagis (biologics for respiratorysyncytial virus (RSV))

¥15bn

¥59bn

Under development
research

GBS-010(PEG-filgrastim)

G-Lasta/Neulasta (biologics forneutropenia caused by chemotherapy)¥8bn¥208bnNon-clinical trials havebeen completed.

1 company in Japan

GBS-011(darbepoetin alfa)

Nesp/Aranesp (biologics for renal
anemia)

¥23bn

¥92bn

Phase 3

Sanwa Kagaku
Kenkyusho¥115bn¥1,456bn

Total

In terms of the other candidates in the pipeline, the Company is currently developing drugs on a number of themes, including for cancer and immune
disorders.
Note: the potential market scale is calculated as approximately 40% of that of the innovator drugs (innovator drugs net sales × biosimilar penetration
volume rate 60% × 70% of the innovator drug price)
Source: Prepared by FISCO from the Company materials

2. New biologics business
For new biologics, the Company has licensed-out the anti-integrin alpha 9 antibody to Kaken Pharmaceutical, butlittle progress has been made for its development. In this situation, the Company is focusing on GND-004 as a novel
antibody drug candidate for the ophthalmic diseases and cancer fields. This is because GND-004 is an angiogenesis
inhibitor with a different mechanism of action to Ranibizumab and Aflibercept, so demand is expected from patientsfor who both drugs are not effective or for who bevacizumab is not effective. In September 2017, the Company filed
for a patent for the antibody, and since the fall of 2018, it has been conducting full-scale licensing-out activities andaiming to conclude an agreement at an early stage. It appears to have already sounded-out major pharmaceuticalmanufacturing companies, and we shall be paying attention to developments in the future. In addition to these drugs,
it is also progressing joint research with academia and other partners for several other development candidate drugs.
New biologics
Development code

Indication

Progress

Partner

GND-001(anti-integrin alpha 9 antibody)

Immune diseases, cancers

Development research

Kaken Pharmaceutical

GND-004

Ophthalmic diseases,
cancers

Development research

Conducting licensing-out
activities

GND-007

Immune diseases

Basic research-

Source: Prepared by FISCO from the Company website

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

Status of the development pipeline

3. New biotech business
Since joining the NK Group in 2016, the Company has started fully fledged measures for a new biotech business,
which will be centered on the regenerative medicine field. In October 2016, Japan Regenerative Medicine, which
is a member of the NK Group and with which the Company has a capital and business partnership, progressed
the clinical trials it had been conducting, which are for a therapy that aimed to use intra-cardiac stem cells toimprove cardiac function for the first time in the world, to the pioneering product review designation system*. If
steady progress is made, this review will be completed in 2020 toward a market launch in 2021. The Company
has been supporting Japan Regenerative Medicine, including in the non-clinical trials and the development of the
manufacturing method. The current clinical trial is for autotransplantation, but going forward they would like toconduct further joint development including to investigate the possibility of allotransplantation and to expand its
indications. Therefore, for the future, they have in sight its development for the European and United States markets.
* For innovative new drugs that meet certain requirements, such as the severity of the disease they are indicated for, the aim is toshorten the approval review period by designating these drugs as pioneering products from an early stage of their development,
and treating them as a priority for the consultations and review relating to the regulatory approval. Through utilizing this system, it ispossible to reduce the standard review period to 6 months, which is around half of the length of the usual time.

Also, in February 2017, the Company entered into a joint research agreement (for 3 years, up to February 2020) withJuntendo University for immunological tolerance* induction. The aim is to commercially launch a new immunosuppressive therapy method that utilizes immune tolerance, including the development of the antibodies required forthis research. As this research is based on the existing research findings of Juntendo University’s Atopy ResearchCenter, clinical studies on renal transplantation and liver transplantation have already been conducted, and cases
have been confirmed in which the amount of immunosuppressive drug to be taken was reduced or it was no longer
necessary to take it. Related to this research, in September 2017 the Company concluded a development andmanufacturing outsourcing agreement with Medinet Co., Ltd., <2370> for the processing technologies for the
immune cells that will serve as the antibodies.
* It refers to a condition in which one’s own cells that are responsible for the immune function do not recognize extraneous antigens asforeign substances and the immune reaction does not occur.

In addition to the above, with the aim of launching a business for a treatment for diabetic nephropathy using
autologous bone marrow mesenchymal stem cells, which is being researched by Sapporo Medical University, inMay 2017 the Company established Minerva Medica (investment ratio 25%), together with AIN HOLDINGS <9627>
and North Pacific Bank, Ltd., <8524>. For this research, a certain level of effects has already been demonstrated inanimal experiments, and going forward, the plan is to conduct clinical trials after establishing a stable cell production
system and a safe and effective treatment method, toward its market launch at an early stage.
New biotech business (regenerative medicine field)
Development productIndicated field

Progress

Joint development company,
university, etc.

Intra-cardiac stem cells

Improving heart functions inchildrenUndergoing clinical trials using
the pioneering product review Japan Regenerative Medicine
designation system

Immunological tolerance
induction

Auto-immune diseases, organtransplantation, allergies

Basic research stage

Juntendo University

Bone marrow mesenchymal
stem cells

Diabetic nephropathy

Basic research

Sapporo Medical University,
Minerva Medica

Source: Prepared by FISCO from the Company website

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15 21

COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.

30-Aug.-20184584 TSE Mothers

http://ir.g-gts.com/en/Top.html██Results trends
Aiming for a re-start under the new management system from FY3/19
1. Overview of FY3/18 results
In the FY3/18 results, net sales decreased 2.7% YoY to ¥1,059mn, the operating loss was ¥913mn (compared toa loss of ¥1,184mn), the ordinary loss was ¥903mn (a loss of ¥1,176mn), and the net loss was ¥904mn (a loss of¥1,224mn).
Net sales of filgrastim BS increased 3.6% YoY to ¥852mn, while revenue from intellectual property rights, etc., rose
41.1% to ¥121mn, and in addition, revenue from services of ¥29mn was recorded. In costs, R&D costs, centered on
the biosimilar business, were ¥1,107mn, down ¥325mn YoY, while development itself is progressing steadily. Also,
other SG&A expenses remained at basically the same level as in the previous fiscal year. As a result, the operating
loss contracted ¥270mn YoY, which was mainly due to the reduction in R&D costs, while it was also ¥63mn lessthan the Company forecast.
FY3/18 results(¥mn)
FY3/17

FY3/18ResultCompany
targetResultvs. sales

YoY change

vs. targetchange

1,089

1,166

1,059

-

-29

-106

(filgrastim net sales)

822

-

852

80.5%

+30

-

(other revenue)

267

-

207

19.5%

-60

-

692

-

637

60.1%

-54

-

1,876

-

1,550

146.3%

-325

-

1,433

1,197

1,107

104.5%-325-89

Operating loss

-1,184-977-913-86.2%

270

63

Ordinary loss

-1,176-992-903-85.2%

273

88

Net loss-1,224-994-904-85.4%

319

89

Net sales

Gross profit
SG&A expenses(R&D expenses)

Source: Prepared by FISCO from the Company’s financial results

2. FY3/19 outlook
The forecasts for FY3/19 are for net sales to be basically unchanged YoY at ¥1,060mn, an operating loss andordinary loss of ¥1,180mn, and a net loss of ¥1,182mn. The outlook is for filgrastim BS net sales to remain ataround the same level as in the previous fiscal year, as although they will be impacted by the revisions to drug
prices, the increase in quantity will also have an effect. However, the plan is to increase R&D costs by ¥192mn YoY
to ¥1,300mn, mainly for GBS-007, so the operating loss will grow slightly compared to in the previous fiscal year.
In terms of the level of R&D costs, as the Company will incur development costs for biosimilars and new biologics
and costs to enhance the new biotech business, it is forecast that going forward, they will be around ¥1,300mn ayear for the foreseeable future.

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

Results trends

In June 2018, the Company elected two new directors (one is an outside director) at the General Meeting of
Shareholders and started a new management structure. In addition, it introduced a business headquarters system
and is aiming to strengthen the business department structure. The newly appointed director, Mr. Ryo Noguchi, isa representative director of the NK Group companies of Japan Regenerative Medicine, and GeneTech Co., Ltd.,and the aim is to strengthen cooperation with NK Group companies in the future. Also, Mr. Norikazu Eiki, who is
the outside director, was the Chairman and Representative Director of the former Bayer Yakuhin Ltd., and he hasa wide network of connections with overseas pharmaceutical companies. He also has a wide network elsewhere,
including as a member of the Ministry of Health, Labor and Welfare’s Project Committee on Biosimilars, and he isexpected to contribute to developing the Company’s business.
* From April 2018, the Company established a four headquarter structure; the business development headquarters, the R&D
headquarters, the pharmaceutical headquarters, and the business administration headquarters.

FY3/19 outlook(¥mn)
FY3/18

FY3/19ResultCompany target

Net sales

1,059

1,060

YoY change
0(R&D expenses)

1,107

1,300

192

Operating loss

-913

-1,180-266

Ordinary loss

-903

-1,180-276

Net loss-904-1,182-277

Source: Prepared by FISCO from the Company’s financial results

Will raise funds by issuing share subscription rights
to promote its business in the future
3. Financial position and fund raising
Looking at the Company’s financial position at the end of FY3/18, total assets were down ¥681mn on the endof the previous fiscal year to ¥3,025mn. The main change factors were that in current assets, cash and deposits
decreased ¥488mn, while accounts receivable declined ¥182mn. Also, in non-current assets, shares of subsidiaries
and affiliates (including Minerva Medica) increased ¥50mn.
Total liabilities were up ¥215mn on the end of the previous fiscal year to ¥421mn. Looking at the main change factors,
there were increases in arrears of ¥179mn and accounts payable of ¥60mn, while income taxes payable decreased¥25mn. Total net assets were down ¥896mn to ¥2,604mn, mainly due to the recording of a net loss of ¥904mn.
In FY3/17, the Company raised funds of ¥3,931mn through a capital increase from a third-party allocation and theexecution of share subscription rights, thereby supplementing its funds. But to pay for upfront business investmentin the future, mainly for R&D costs, in July 2018 it newly issued share subscription rights through a third-party
allocation. The maximum number of shares to be issued is 3 million shares (share dilution rate, 15.68%), andwhen provisionally calculated based on the initial execution price of ¥1020.5, the amount of funds raised will beapproximately ¥3bn. Since the lower limit exercise price has been set at ¥714.5, it will raise at least approximately¥2bn if all the rights are exercised (the closing price on July 13 was ¥757).

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17 21

COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.

30-Aug.-20184584 TSE Mothers

http://ir.g-gts.com/en/Top.html

Results trends

For the uses of the funds raised, it is anticipated that ¥1,350mn will be used for preparatory costs up to the timeof manufacturing and sales approval for the products whose development the Company is progressing within theexisting biosimilars pipeline, ¥650mn will be used for the development costs of 1 or 2 new products in the new
biosimilar pipeline, and ¥1,059mn will be used to develop existing new biologics and to license-in new biologics,
and also for the costs to enhance the new biotech business.
Balance sheet(¥mn)
FY3/15

FY3/16

FY3/17

FY3/18Change

1,092

1,520

3,421

2,692

-729

599

817

2,379

1,891

-488

54

173

284

332

48

Total assets

1,146

1,694

3,706

3,025

-681

Total liabilities

876

1,290

205

421

215

775

810

-

-

-

270

403

3,500

2,604

-896

21.7%

22.6%

93.8%

85.0%

-8.8ptCurrent assets(cash and deposits)
Non-current assets(Interest bearing debt)
Net assets
Management indicators
Shareholders’ equity ratio

Source: Prepared by FISCO from the Company’s financial results

Outline of the 6th share subscription rights
Maximum number ofissued shares

3 million shares (share dilution rate, 15.68%)

Initial exercise price¥1020.5

Lower limit exercise price¥714.5

Exercise price adjustment

Fixed at 92% of the closing price on the trading day immediately before the effective date of each exercise request

Estimated amount of funds
to be raised¥3,059mn (assuming the initial exercise price)

Exercise period

July 2, 2018, to July 1, 2020

Purpose of fund raising· Toward advancing the businesses in the future, to secure the funds necessary to further enhance corporate value bytargeting the fields of rare and intractable diseases, especially in the pediatric field· To improve liquidity by expanding the investor groups

Uses of funds raised· Within the existing BS pipeline, for the costs to finalize the manufacturing method for 3 products, to prepare for
their supply as commercial products, and to prepare for the applications toward acquiring manufacturing and sales
approval (¥1,350mn)· For the costs to develop the manufacturing process for 1 or 2 products in the new BS pipeline, and the costs relating
to quality tests and non-clinical trials (¥650mn)· For the R&D costs of existing new biologics and to license-in new biologics, and the costs to enhance the new biotech
business (¥1,059mn)

Source: Prepared by FISCO from the Company’s results briefing materials

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COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html██The business strategy for the future
Expects to achieve operating profit from 2022 to 2023,
when multiple biosimilars are scheduled to be market launched
As the business direction it is aiming for in the future, the Company is advocating being an “Biotech Engineering
Company, striving for value creation,” and in addition to the fields of rare and intractable diseases, it is expanding thefields it targets for developments, such as to pediatric diseases (including juvenile diseases) and diseases in Asia.
Based on the expertise in developing biologics it has accumulated since its foundation and also its experience andexpertise in developing highly efficient manufacturing processes for biosimilars, it policy is to work to create value
not only through advancing the development of new drugs by combining various drug-discovery seeds, but also
by leveraging synergies with the NK Group to develop new treatment methods and medical services (such as early
diagnosis and genetic testing services).
As the differentiation technologies that it will strengthen in the future, the Company cites technologies for enhancing
the effectiveness of the medicinal effect, technologies that enable the expansion of the treatment site (technologies
to transport the drug to the target site), improvements in medication compliance (improving the sustainability of the
medicinal effect), and the reduction of side effects (identifying molecules for which there is a risk of side effects). By
combining these technologies, it will develop high value-added biologics. For technologies that make it possible toexpand the treatment site, in April 2018 the Company entered into a capital and business partnership agreementwith NanoCarrier, and it is expected to utilize this company’s technologies, including its micellar nanoparticle (polymer
micelle) technologies, for this purpose.
Provision of new treatment methods

Source: reprinted from Explanatory Materials on the Business Direction being aimed for by GTS

We encourage readers to review our complete legal statement on “Disclaimer” page.

19 21

COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

The business strategy for the future

Also, the recent addition of the field of pediatric diseases as a new target for developments is because the development of new drugs in this field is insufficient and competition is not intense, also that there is currently a boom indevelopments for rare and intractable diseases with high drug prices. Further, in the future, alongside the decline
in the birthrate, it is considered that the spotlight will be placed on developments in the field of pediatric diseases.
Pharmacy dispensing medical expenses related to pediatric diseases in Japan were approximately ¥500bn in 2015,
accounting for only about 6.25% of the total, but there are many intractable pediatric diseases and the growthpotential for this field is considered to be large. One pediatric disease is being targeted by the treatment method toimprove cardiac functions using intra-cardiac stem cells that is currently being researched by Japan Regenerative
Medicine, so we will be paying attention to development efforts in the future, including for regenerative medicine.
Pediatric diseases’ potential

Source: reprinted from Explanatory Materials on the Business Direction being aimed for by GTS

In terms of the image for results in the medium term, sales are increasing from the progress made in the development
and the market launches of the existing pipeline biosimilars (GBS001 to GBS011). In addition, the Company’s
strategy is to aim to accumulate sales from the new pipeline drugs (1 or 2 products) from 2025 onwards. As productswith upside potential, they are expected to contribute to sales from being licensed-out overseas. If steady progress
is made in the development of the existing pipeline drugs, then 2 to 3 products are scheduled to be sequentiallymarket launched from 2020 onwards. So at FISCO, we think it is possible that the Company will become profitable
at the operating income stage from around 2022 to 2023.

We encourage readers to review our complete legal statement on “Disclaimer” page.

20 21

COMPANY RESEARCH AND ANALYSIS REPORTFISCO Ltd.
http://www.fisco.co.jp

Gene Techno Science Co.,Ltd.
4584 TSE Mothers

30-Aug.-2018
http://ir.g-gts.com/en/Top.html

The business strategy for the future

Strategy

Source: reprinted from Explanatory Materials on the Business Direction being aimed for by GTS

We encourage readers to review our complete legal statement on “Disclaimer” page.

21 21

Disclaimer
FISCO Ltd. (the terms “FISCO”, “we”, mean FISCO Ltd.) has legal agreements with theTokyo Stock Exchange, the Osaka Exchange,and Nikkei Inc. as to the usage of stock priceand index information. The trademark and value of the “JASDAQ INDEX” are the intellectual
properties of the Tokyo Stock Exchange, and therefore all rights to them belong to the Tokyo
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This report is based on information that we believe to be reliable, but we do not confirm or
guarantee its accuracy, timeliness,or completeness, or the value of the securities issued bycompanies cited in this report. Regardless of purpose,investors should decide how to use
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use. We provide this report solely for the purpose of information, not to induce investment or
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This report was prepared at the request of its subject company using information provided
by the company in interviews, but the entire content of the report, including suppositions andconclusions, is the result of our analysis. The content of this report is based on informationthat was current at the time the report was produced, but this information and the content of
this report are subject to change without prior notice.
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FISCO Ltd.