CORPORATE REPORT 2022
Bringing Smiles to Everyone
KAKEN helps improve the quality of life of patients by serving as many people as possible to return smiles of happiness to their faces, through supplying superior pharmaceuticals.
In this endeavor, we always strive to be "the best," rather than pursuing the scale of business.
We aspire to be, and to remain, a company that can create "Joys" for patients, society and our employees.
We also hope to contribute to society by demonstrating KAKEN's distinctive and vigorous presence.
Corporate Philosophy
KAKEN helps improve the quality of life of patients by serving as many people as possible to return smiles of happiness to their faces, through supplying superior pharmaceuticals.
Business Philosophy
KAKEN "Three Joys"
Joy for patients | Joy for society | Joy for employees |
We strive to create and supply | We recognize our social | Our objective is to become |
efficacious drugs that satisfy the | responsibility as a pharmaceutical | a company with vitality and |
needs of patients and medical | company, engage in all activities | presence whose employees enjoy |
professionals. | with high ethical standards, and | and take pride in their work. |
aspire to earn society's trust. |
C O N T E N T S
Value Creation Story
Strategy
Foundation for
Creating Value
Financial and
Corporate Data
Editorial Policy
- A History of Value Creation
- Value Creation Process
- Sources of Value Creation
8 President's Message
12 Priority (Material) Issues
14 Long-Term Business Plan 2031
18 Growth Strategy
- Sustainability Strategy
- Engagement with Customers
- Corporate Governance
28 Management Team
30 Compliance and Risk Management
- Engagement with Society and Local Communities
- Environmental Management
35 Human Resource Strategy
38 Financial and Non-Financial Highlights
- FY2021 Operating Results and Financial Condition
- Consolidated Balance Sheets
- Consolidated Statements of Income
- Consolidated Statements of Comprehensive Income
- Consolidated Statements of Changes in Net Assets
- Consolidated Statements of Cash Flows
- Notes to the Consolidated Financial Statements
- Corporate and Share Information
This report has been edited with the objective of helping KAKEN's various stakeholders (including shareholders and investors) to understand the Company's management foundation and strengths that it has built to date, as well as the sustainable growth it aspires to achieve through creation of corporate value in the future, using the International Integrated Reporting Framework of the Value Reporting Foundation (now integrated in the IFRS Foundation) and Guidance for Collaborative Value Creation by the Ministry of Economy, Trade and Industry as reference.
Reporting Period
FY2021 (April 1, 2021 to March 31, 2022)
Note: Some information from before and after the period above is included.
Scope of This Report
Kaken Pharmaceutical Co., Ltd. ("the Company") and its consolidated subsidiaries (collectively, "the KAKEN Group" or "the Group")
Cautionary Statement
This report contains forward-looking statements on the Group's business. They are projections based on information available at the time this report was written, and may differ from actual results due to a variety of factors. In addition, although this report includes information related to pharmaceuticals (including those under development), these statements are not intended to be advertisements or medical advice.
KAKEN Corporate Report 2022 1
Value Creation Story
Launched Hernicore
(lumbar disc herniation treatment)
A History of Value Creation Maintaining a deep understanding of patient needs and continuously providing new treatment options
With a deep dedication to meeting the needs of patients, KAKEN conducts collaborative research and development and clinical development with companies in Japan and overseas, in addition to in-house drug discovery, to provide products that are the first of their kind in Japan or the world.
Launched Clenafin
(onychomycosis treatment)
As the first topical treatment for | Background of Development | |
onychomycosis in Japan, Clenafin | Oral antifungal drugs were the only | |
provided a new treatment option | ||
onychomycosis treatment available in | ||
without the drug interactions and | ||
Japan, but these drugs were associated | ||
adverse drug reactions, such as | with drug interactions and adverse | |
liver damage, seen with oral | drug reactions, including liver damage. | |
antifungal drugs. Global sales | There was a need for a new external | |
are expanding, partly through | medicine that would be effective against | |
out-licensing to local companies in | onychomycosis while having fewer | |
safety concerns. | ||
North America, Asia and Europe. | ||
Hernicore provided a new lumbar hernia treatment option that improves leg pain and other symptoms. Condoliase, the active ingredient, is injected into the intervertebral disc to reduce internal pressure. We are aiming to establish Hernicore as a treatment positioned between conservative therapy and surgery (manufactured and distributed by Seikagaku Corporation).
Background of Development
Previously, lumbar disc herniation treatments were limited to two options- conservative therapy or surgery.
Our Track Record of
Launched Athletan
Launched Artz (anti-osteoarthritis agent) (1987)
Launched Artz Dispo (1993)
2020
Creating New
Value
Founding Ideas
The origin of Kaken Pharmaceutical Co., Ltd. can be traced back to the Institute of Physical and Chemical Research (Riken), which was established in 1917. In 1948, the Company started its business as Kagaku Kenkyusho. The Company's first president, Yoshio Nishina, who was called the father of modern physics in Japan, said that his mission was to apply basic scientific research and its findings to industry, and began
(antifungal agent)
Developed following initial formulation in Japan involving an animal testing method for topical antifungal agents, this product became the foundation for current antifungal agent development.
Hyaluronic acid has been shown to improve symptoms of knee osteoarthritis, shoulder periarthritis and other joint diseases. This led to the launch of Artz, the world's first intra- articular injection solution using hyaluronic acid as the main active ingredient (manufactured and distributed by Seikagaku Corporation).
Background of Development
The conventional treatments for painful joint diseases such as knee osteoarthritis and shoulder periarthritis were orally administered nonsteroidal anti- inflammatory drugs (NSAIDs) and locally administered anesthetics and steroids. However, because of problems such
as gastrointestinal damage caused by NSAIDs and joint disorders caused by steroids, there was a need for a safer, more effective drug.
2014
2001
1993
2018
2016
manufacturing and
Launched Ecclock
selling pharmaceuticals as a way of implementing theoretical research in business.
1948
1971
1953
Launched
Penicillin KAKEN
Using the technology of Riken, from which it originated, the Company began manufacturing and selling penicillin, which was needed by many patients at the time.
1987
Launched Brufen
(anti-inflammatory, analgesic and antipyretic agent)
With ibuprofen as the active ingredient, Brufen has analgesic and anti-inflammatory effects for arthralgia and arthritis, with a wider range of applicable conditions, including acute upper respiratory tract infection and the common cold.
1992
Launched Mentax
(anti-trichophyton agent)
The world's first topical anti- trichophyton agent in the benzylamine class. Won the Okochi Memorial Grand Production Prize for the development of butenafine hydrochloride, the active ingredient.
Launched Fiblast
(wound-healing agent)
Fiblast, the world's first human bFGF (basic fibroblast growth factor) formulation, promotes healing by acting on various cells related to wound healing. It is also the world's first spray-onwound-healing agent, and is easy to use because it can be easily applied without directly touching the affected area. This product was a milestone in regenerative medicine, and is increasingly being used in the treatment of other conditions.
Background of Development
There was a need for a new treatment to address the increasing incidence of bedsores and intractable skin ulcers due to the aging population in Japan. Moreover, external treatment options for wound healing were limited to ointments.
Launched Regroth
(periodontal regenerative agent)
Safe, convenient and covered by national health insurance (NHI-listed) in Japan, Regroth is the world's first periodontal regenerative agent. With its debut, Regroth is expected to increase the value of periodontal regeneration therapy, and has contributed
as a new therapeutic option for periodontal disease.
Background of Development
There were no periodontal regeneration drugs sold elsewhere in the world, and the only material approved in Japan for regenerating periodontal tissue was not NHI-listed, so its use was limited.
(primary axillary hyperhidrosis treatment)
Ecclock was the first NHI-listed external treatment option for primary axillary hyperhidrosis in Japan. Among other factors, we focused on developing a dosage form that would ensure safe use, including an applicator that allows the gel to be applied without directly touching it.
Background of Development
The first-line treatment for primary axillary hyperhidrosis was an aluminum chloride topical; however, it was not NHI-listed in Japan, and there was a need for a new external medicine for this disorder.
Technologies developed by Riken form | Growth driven by establishment | Provided medicines of excellent | |||
1940s | 1960s of new research facilities and a | 1990s | |||
KAKEN's | the roots of Kaken Pharmaceutical | quality in a drive to be "the best" | |||
strengthened sales structure | |||||
Technological | |||||
Foundation | With its roots in Riken, which has made many contributions to | Based on ideas from academia, KAKEN developed products | In the 1990s, KAKEN expanded its R&D investment and | ||
modern science in Japan, KAKEN has provided medicines to | from new viewpoints, including Japan's first digestive enzyme | further improved its technologies. The Company became the | |||
meet the needs of the times based on its technological | preparation in capsule form and the world's first oral anti- | first in the world to successfully synthesize and develop | |||
development capabilities. The Company applied Riken's | inflammatory enzyme preparation. The Company also applied | benzylamine-derived butenafine hydrochloride, which had a | |||
culturing techniques to commercialize penicillin, which had | its technologies to address social problems. In the case of | chemical structure completely different from that of existing | |||
been attracting interest as a treatment specifically for | Minamata disease for example, it successfully synthesized an | athlete's foot medicines. It grew into strategic global | |||
pneumonia, an intractable disease at the time. KAKEN took | antifungal agent to replace organic mercury compounds that | product Mentax. For Artz, which had been sold in an ampoule, | |||
the lead in penicillin production in Japan. Streptomycin, a | were the primary medicines for athlete's foot at the time. In | the Company launched Artz Dispo, a kit product with a | |||
specific treatment for tuberculosis, led to the development | the 1970s, the Company opened new research facilities, and | disposable pre-filled syringe, to reduce the risk of infection. | |||
of a variety of fermented products. | built a system capable of adapting to increasingly stringent | Underpinning the Company at this time was its belief, set | |||
laws and regulations, and enhanced its sales capabilities. The | forth in the late 1980s, in striving to be "the best company, | ||||
Drug Research Center in Kyoto in particular was equipped | even if not the biggest." | ||||
with state-of-the-art equipment and tools, demonstrating | |||||
highly reliable safety testing (preclinical studies). |
2 KAKEN Corporate Report 2022
2000s | Advance priority research themes through |
organizational improvements and | |
and onward | concentration of resources |
The Drug Research Center and the CMC Center have introduced state-of-the-art equipment and technologies, and cooperate in the advancement of drug discovery research. KAKEN focuses its investments and human resources on R&D themes in fields where its experience, technologies and foundations can best be utilized-the immune system, the nervous system and infectious diseases. In FY2017, the Company entered into
-
collaborative research agreement with Switzerland-based Numab Therapeutics AG- which has a multi-specific antibody technology platform-for the identification of a multi-specific antibody candidate for the treatment of inflammatory diseases.
Based on KAKEN's belief that the foundation of research and development is people, the Company is promoting human resource development both in-house and externally. As part of that effort, the Company sends researchers to research institutions in Japan and overseas to sharpen their expertise, and strives to introduce the latest technologies and knowledge.
KAKEN Corporate Report 2022 3
Value Creation Story
Value Creation Process
With the aim of fulfilling its corporate philosophy of "help improve the quality of life of patients by serving as many people as possible to return smiles of happiness to their faces, through supplying superior pharmaceuticals," the KAKEN Group provides drugs and information that contribute to the quality of life of patients from a distinctive viewpoint. We will continue striving to create value based on our unique strengths.
Corporate | KAKEN helps improve the quality of life of patients by serving as |
many people as possible to return smiles of happiness to their faces, | |
Philosophy | |
through supplying superior pharmaceuticals. | |
INPUT
Financial capital
• Safe and sound financial position |
¥137,747 million |
BUSINESS MODEL
We leverage our strengths
to provide new treatment options
OUTPUTOUTCOMES
Joy for patients
• Equity |
(As of March 31, 2022) |
Manufacturing capital
to patients. | Patients and | |||||||
medical | ||||||||
professionals | ||||||||
Innovative drugs, including products that are the first of
• Longer healthy life expectancy |
• Treatments that improve quality |
- Capital expenditures in capacity expansion/renovation ¥3,510 million
(Year ended March 31, 2022)
Intellectual capital
- R&D investment
¥8,420 million
(Year ended March 31, 2022)
-
Drug Research Center
2 locations (Kyoto and Shizuoka)
Natural capital
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Deep
Joy for
patients
KAKEN's heritage
Sharing joy
through
pharmaceuticals
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Long-Term Business
Plan 2031
-Kaken Vision for Transformation-
For details, see pages 14-17
their kind in Japan
or the world
Dermatology
ClenafinFiblast
of life of patients and their family |
members |
• Meeting medical needs for |
adequate treatments |
• Addressing global needs | Contributing to |
• Provision of proper pharmaceutical | |
people's well- | |
and related medical information | |
being through | |
Joy for society | better quality |
- CO2 emissions 20,282 t-CO2
-
Electricity consumption
25,608 thousand kWh - Water consumption
2,674 thousand m3 (Shizuoka Site)
Social capital
- Main offices 8
- Sales offices 34
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Growth Strategy
For details, see pages 18-21
Ecclock
Orthopedics
of life |
• Development of sustainable |
supply chains |
• Consideration for local |
communities and the environment |
based on high ethical standards |
• Stable and continuous returns to |
shareholders |
Human capital
ArtzHernicore
Joy for employees
- Number of Group employees
1,164
(As of March 31, 2022)
Sources of Value Creation
For details, see pages 6-7
Foundation for Creating Value
Human Resource Strategy | Corporate Governance | Environmental Management |
For details, see pages 35-37 | For details, see pages 24-29 | For details, see pages 33-34 |
Other Areas
SeprafilmRegroth
First in the world First in Japan
- Job satisfaction as professionals who meet patient needs
4 KAKEN Corporate Report 2022 | KAKEN Corporate Report 2022 5 | |
Value Creation Story
Sources of Value Creation
KAKEN focuses on selected therapeutic areas and delivers new treatment options to patients. Here we describe our unique sources of value creation for accomplishing those tasks.
Ability to Perceive Needs (Ability to Identify Issues)
Expertise and Networks from Focusing on
Specific Therapeutic Areas
We focus on dermatology and orthopedics, and have useful, innovative products in each of these areas. By concentrating our efforts in these areas, we have raised the quantity and quality of the specialized knowledge of our medical representatives (MRs), and by assigning them to specific regions they are able to tailor the information they provide to the medical needs of those regions. These actions have helped us build strong relationships of trust with medical professionals. As a result, we are able to reflect the patient feedback that we obtain through the frontlines of medicine in new product development and formulation improvements.
Marketing
& Sales
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Ability to Meet Needs
(Ability to Find Solutions)
Flexible Approach to Finding Solutions
We identify the best solution with a flexible approach by analyzing unmet medical needs using the patient feedback we obtain from medical professionals at the frontlines of medicine. We strive to speed up the R&D process to provide the innovative drugs that patients need as quickly as possible, not only by leveraging our own technologies and experience, but also by using advanced technologies and knowledge from outside the Company. We also apply the information that MRs obtain at the frontlines of medicine to devise product formulation and packaging solutions.
We provide new therapeutic options to help improve the quality
Example of life of patients suffering daily from the symptoms of disease. In addition, we work with doctors to promote patients' disease
Example
We continue to provide products such as the onychomycosis treatment Clenafin and the anti-osteoarthritis agent Artz that have long been appreciated by many patients facing dermatology- and orthopedics-related issues. In earning the
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awareness based on the information we gather and take steps to increase the convenience of drugs by improving formulations and through additional specifications and packaging. We have also introduced a drug discovery platform that uses AI to speed up the research and development of
trust of doctors, our MRs have improved their expertise and built relationships with a wide range of medical professionals, including pharmacists, nurses and rehabilitation staff. We value the information we
get at the frontlines of medicine. For example, having the opportunity to attend surgeries in operating rooms to explain the use of our medical devices such as adhesion barrier materials is an important and rewarding experience as it allows MRs to see our products properly used for the benefit of patients.
- Our MRs emphasize face-to-face communication supplemented by digital technology as a tool for efficiently sharing information.
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R&D and
Production
innovative drugs by increasing the probability of success in drug discovery. By combining this platform with our drug discovery experience and knowledge, we will shift to a data-driven discovery research process.
Flexible Cooperation
To create advanced drugs that address new needs and make those drugs available to patients as quickly as possible, we assemble cross-departmental project teams for specific objectives. Through free and lively discussion based on their expertise, team members carry out efficient drug discovery. This serious and passionate approach across departmental boundaries is one of KAKEN's strengths. We are striving to create further value through new challenges by increasing cooperation with domestic and overseas biopharmaceutical startups that have innovative technologies, and with companies that have unique technologies in other areas.
KAKEN employees multiply their strengths by working toward a
Example common goal as one team through cross-departmental collaboration. Also, our flexible corporate culture has become a strength by
maximizing our presence, which has led to collaboration with other companies in the areas of dermatology and orthopedics. The acquisition of ARTham, which has expertise in drug repositioning (for details, see page 8), has augmented our R&D capabilities and is expected to broaden the range of solutions we can provide patients and medical professionals at the frontlines of medicine. Furthermore, through our exploration of new modalities, such as the development of therapeutic antibodies in collaboration with Numab Therapeutics AG, we expect more additive and synergistic effects.
6 KAKEN Corporate Report 2022 | KAKEN Corporate Report 2022 7 |
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Kaken Pharmaceutical Co. Ltd. published this content on 10 November 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 November 2022 09:16:04 UTC.