Download annual review 2011

Annual Review
2011
Year ended March 31, 2011
Profile
Mochida Pharmaceutical Co., Ltd. responds to the widespread requirements
of medical care by putting into practice its motto of “Foresighted, innovative
research.” With the advent in Japan of the aging society and a stronger
emphasis on the quality of life (QOL) and a continued focus on health,
expectations regarding medical care are growing daily.
We aim to do as much as one company can to contribute to the world of
medical care. At Mochida Pharmaceutical, we embrace that objective as our
mission, and are engaging proactively in the far-reaching areas that constitute
medical care.
Corporate Philosophy
Throughout the Company’s history, it has stressed the importance of
foresighted creativity to develop unique products and technologies for the
medical and pharmaceutical world, thereby contributing to the improvement of
human health.
Contents
1
Consolidated Financial Highlights
2
Message f rom the President
4
The Year in R eview
6
Business Activities
8
Research & Development
1 0
Production
1 2
Licensing A ctivities
1 4
Pharmaceuticals
1 8
Skin C are P roducts
2 0
Nutraceuticals
2 1
Main Product L isting
2 2
Highlights o f O ur G rowth
2 4
Corporate Governance
2 6
Six-Year Summ ary
2 7
Consolidated Statements o f I ncome ( Unaud i t e d )
2 8
Consolidated Balance S heets (Unaudited)
3 0
Consolidated Statements o f C hanges i n N e t As s e t s ( U n a u d i t e d )
3 1
Consolidated Statements o f C ash Flows ( U n a u d i t e d )
3 2
Management
3 3
Corporate Data
Cover: The stained-glass window
expresses a prayer for health
and depicts St. Luke, the patron
saint of the medical profession,
administering medicine to people
who are suffering.
This window is on the first floor of
our Nagoya Office.
Consolidated Financial Highlights
Mochida Pharmaceutical Co., Ltd. and Consolidated Subsidiaries
Years ended March 31
Thousands of
U.S. Dollars
Millions of Yen
2010
2011
¥ 78,549
$ 954,181
2011
Net sales
¥ 79,340
Operating income
11,509
13,949
138,414
Income before income taxes and minority interests
8,155
15,783
98,080
Income taxes
2,821*1
5,913*2
33,933
Net income
5,333
9,869
64,147
Total assets
108,577
106,845
1,305,799
11,642
9,589
140,019
R&D expenditures
Capital expenditures
1,757
1,977
23,782
Yen
Net income per share
U.S. Dollars
¥ 48.4
¥ 86.9
$ 0.58
22.0
25.0
0.26
Cash dividends per share
*1: As a result of tax effect accounting, corporate tax, resident tax and business tax (total ¥4,284 million), an income tax adjustment (-¥1,462 million) is included.
*2: As a result of tax effect accounting, corporate tax, resident tax and business tax (total ¥5,506 million), an income tax adjustment (+¥407 million) is included.
Note: Unless otherwise indicated, all dollar figures herein refer to U.S. currency. Yen amounts have been translated into U.S. dollars, for convenience only, at the
rate of ¥83.15=$1.00, the approximate exchange rate on March 31, 2011.
Net Sales
Net Income
(Millions of Yen)
90,000
75,000
Net Income per Share
(Millions of Yen)
(Yen)
9,869
10,000
74,066 74,573 75,181
78,549 79,340
8,387
100
86.9
8,754
80
8,000
60,000
6,000
69.8
6,030
5,333
60
48.9
45,000
4,000
40
2,000
20
30,000
15,000
0
2007
2008
2009
2010
2011
0
2007
2008
2009
2010
2011
75.3
0
2007
48.4
2008
2009
2010
2011
Mochida Pharmaceutical Group 1
Message from the President
The pharmaceutical industry’s operating environment remains harsh, due mainly
to the continued advance of various measures to restrain pharmaceutical
costs and intensified competition among domestic and overseas companies.
In addition, Japan’s National Health Insurance (NHI) revised drug prices in April
2010 and introduced a new drug pricing system on a trial basis, thereby further
spurring changes in the operating environment. Further, Japan’s economic
conditions were suddenly changed by the Great East Japan Earthquake of
March 11, 2011, and the pharmaceutical industry was severely affected.
To achieve steady growth while responding to such changes in the
operating environment, the Mochida Pharmaceutical Group placed priority
on establishing competitive businesses and business fields, emphasizing
partnerships, and thoroughly reviewing its resources, developing each business
under the basic policy of emphasizing profit and continued investment for
the future.
As a result, for the fiscal year ended March 31, 2011, we succeeded in
boosting net sales to ¥79,340 million, up 1.0% in comparison with the previous
year. Operating income fell 17.5%, to ¥11,509 million, and recurring income was
down 19.5%, to ¥12,017 million. Net income declined 46.0%, to ¥5,333 million ,
mostly because of the impact of the earthquake.
Business Overview for the Fiscal Year under Review
Pharmaceutical business segment sales rose at parent company Mochida Pharmaceutical Co., Ltd. on the
growth of Dinagest, an oral progestin for the treatment of endometriosis, and increased sales of generics,
despite the impact from large drug price reductions on our main products.
The recognition of our leading drug Epadel, a treatment for hyperlipidemia and arteriosclerosis
obliterans, is rising more and more following its inclusion in treatment guidelines based on the analytical
results of the Japan EPA Lipid Intervention Study (JELIS) large-scale clinical trial. We are now moving
forward with continued efforts to further increase the product value of Epadel. These include the launch of
clinical trials to gain an additional indication, and the submission of applications to make an Epadel-based
formulation available as a switch-OTC (over-the-counter) drug to meet self-medication demand. Sales of
Dinagest are expected to grow further because the drug is being well received by medical professionals,
and gaining support from patients as well.
In research and development, applications were filed for approval to use the condyloma acuminatum
therapeutic agent Beselna for the additional indication of actinic keratosis. We also initiated early Phase II
trials to confirm the effectiveness of Dinagest for the additional indication of uterine adenomyosis. Other
drugs are also steadily advancing through the development pipeline. We are taking on the challenge
of developing drugs in new fields, such as cellular-based drugs and therapeutic agents for intractable
diseases, while responding to biosimilars (follow-on biologics).
We received manufacturing and sales approval for the antidepressant Lexapro® (escitalopram), which
is expected to become a major new drug, in April 2011, and are working to launch sales within 2011.
Our subsidiary Mochida Pharmaceutical Plant Co., Ltd. (MPP) is advancing highly reliable
and efficient contract manufacturing of drugs using cutting-edge technologies and state-of-the-art
manufacturing facilities that comply with global standards to meet diverse customer needs.
Our subsidiary Mochida Healthcare Co., Ltd. (MHC) posted solid sales with contributions from
new products, despite the stagnant skin care market. MHC will continue to strengthen its ties with
2 Mochida Pharmaceutical Group
dermatologists, provide high-function skin care products based on dermatology, establish brands, and
further develop the skin care market.
Medium-Term Management Plan for Fiscal Years 2010 through 2012
The Mochida Pharmaceutical Group has drawn up a medium-term management plan covering the period
from the fiscal years 2010 through 2012.
Targets for FY2012 are net sales of ¥89,000 million, operating income of ¥13,500 million, and R&D
expenditures of ¥11,500 million. In order to respond to more difficult changes in the business environment
and to ensure continued profitable growth during the coming three years, starting in FY2010, we will
continue to work hard to promote further structural reform in areas including the improvement of head office
functions and the efficient management of the organization under the fundamental policy and aim to further
boost productivity through stronger cooperation and bonds among Group departments. Targeting, in the
long term, specialty pharmaceuticals that will be recognized for the value of their existence on a global
scale, we are pursuing investment in business activities that will lead to future competitiveness.
Furthermore, our core pharmaceutical business will focus its resources on the four major areas of
cardiovascular medicine, obstetrics and gynecology, dermatology, and emergency medicine so as to
further promote strategic alliances which stress the importance of lifecycle management and partnerships.
Furthermore, we will develop high-value-added products which meet the needs of medical professionals
as well as our customers by introducing and utilizing external technologies and technological seeds from
outside sources. We will also challenge new medical fields such as the development of therapeutic drugs
for intractable diseases and cellular pharmaceuticals and will embrace a commitment to biosimilars as well
as generic drugs. As a leader in the manufacture of ethyl icosapentate (EPA-E) preparations, we will work
toward having an Epadel-based drug offered as an OTC drug.
To Our Shareholders and Investors
The Mochida Pharmaceutical Group fulfills its social mission as a pharmaceutical company by creating
and supplying high-value-added products that meet customer needs based on its corporate philosophy
“Throughout the Company's history, it has stressed the importance of foresighted creativity to develop
unique products and technologies for the medical and pharmaceutical world, thereby contributing to the
improvement of human health” and we conduct our corporate activities with high ethical standards. We are
working to become a specialty pharmaceutical company whose presence is recognized worldwide, and to
boost corporate value over the long term.
We thank our shareholders and other stakeholders for your continuing support.
July 2011
Naoyuki Mochida
President
Mochida Pharmaceutical Group 3
T h e Ye a r i n R e v i e w
Overview of Performance
The Mochida Pharmaceutical Group (Mochida Pharmaceutical Co., Ltd. and its consolidated
subsidiaries) has been directing its efforts toward business reforms across all areas of management.
This entails improving the Group’s management system, achieving an appropriate level of staffing, and
increasing productivity throughout the Company.
In the pharmaceutical business, the Group has focused its resources on four major areas:
cardiovascular medicine, obstetrics and gynecology, dermatology, and emergency medicine. With the
aim of establishing itself as a specialty pharmaceutical company, the Group undertook an aggressive
campaign to disseminate academic information concerning mainstay and other products.
The Great East Japan Earthquake of March 11, 2011, struck the Head Office Plant of our
consolidated subsidiary Mochida Pharmaceutical Plant Co., Ltd. (Otawara, Tochigi Prefecture)
and caused major damages to production machinery and drug manufacturing building facilities.
Subsequent recovery works proceeded smoothly, though, and operations have resumed.
In the skin care business, the Group conducted business activities as an expert in basic
skin care products for sensitive skin, and worked to further cultivate the market by stepping up its
marketing activities.
As a result of these efforts, in the fiscal year ended March 31, 2011, the Mochida Pharmaceutical
Group realized consolidated net sales of ¥79,340 million, an increase of 1.0% from the previous year.
Individual Business Segments
In the pharmaceutical business segment, sales increased 0.8% year on year, to ¥75,642 million. While
sales of our major products Epadel, a treatment for hyperlipidemia and arteriosclerosis obliterans, and
Atelec®, a long-acting calcium channel blocker antihypertensive agent, declined as a result of NHI
drug price revisions, sales of Dinagest, an oral progestin for the treatment of endometriosis, steadily
increased, and sales of generics also rose.
In the skin care business segment, sales rose 4.9%, to ¥3,697 million, despite the sluggish
market, with increased sales of the Collage Furfur series of antifungal hair care and body care
products.
4 Mochida Pharmaceutical Group
Profit and Loss
Operating income dropped 17.5%, to ¥11,509 million, mostly because gross profits on sales declined
from NHI drug price revisions while R&D expenses increased. Recurring income fell 19.5%, to ¥12,017
million. Net income dropped 46.0%, to ¥5,333 million, mostly because of the extraordinary losses
posted from damages as a result of the Great East Japan Earthquake.
Research & Development
The Pharmaceutical Research Center continued to focus its efforts on two fields—chronic pain, and
diabetes and obesity—as it pursued the discovery and development of new and original therapeutic
drugs for the global market. The center works to improve the efficiency of research by conducting
joint research with Japanese and foreign organizations. The center is also actively working toward the
introduction of an antibody drug for the treatment of sepsis, a pain medication, and an antidiabetic
drug.
In clinical development, applications were filed for approval to use the condyloma acuminatum
therapeutic agent Beselna for the additional indication of actinic keratosis. We also initiated early
Phase II trials to confirm the effectiveness of Dinagest for the additional indication of uterine
adenomyosis.
Activities for other drugs advancing steadily through the development pipeline included Phase
III clinical trials for MD-0901, an agent to treat ulcerative colitis;Phase II/III clinical trials for MD-0701,
a treatment for pulmonary arterial hypertension; Phase II/III clinical trials on the biosimilar Granulocyte
Colony Stimulating Factor (G-CSF) FSK0808; Phase II clinical trials (in the United States) on Epadel as
a treatment for non-alcoholic steatohepatitis; and Phase I/II clinical trials for JR-031, a cellular-based
drug using human mesenchymal stem cells to treat graft versus host disease (GVHD).
Applications were also filed for the manufacture and sale of an Epadel-based formulation as a
switch-OTC drug.
We received manufacturing and sales approval for the antidepressant Lexapro® (escitalopram) in
April 2011.
We initiated joint Phase III clinical trials for the hypertension medication AJH801 (a combination
of cilnidipine and valsartan) together with Ajinomoto Pharmaceuticals Co., Ltd. in May 2011.
During the fiscal year under review, consolidated R&D expenditures totaled ¥11,642 million.
Pharmaceutical Research Center
Mochida Pharmaceutical Group 5
Business Activities
Aiming to Become
a Comprehensive
Healthcare Company
As the focus of attention turns increasingly toward QOL and the aging society,
health-related issues have moved to center stage in many people’s lives.
As both a healthcare provider and conscientious corporate group, Mochida
Pharmaceutical’s mission is to make a lasting contribution to the world of medical
care. Thus, the Group is taking the initiative in providing innovative medical care
over a wide range of fields.
Through its activities as a key player in ethical drugs and diagnosis
reagents, the Group has been able to develop an extensive and varied product
line. Principal business activities include pharmaceuticals and diagnostic
reagents, skin care products, and nutraceuticals. We endeavor to provide
beneficial products that embody the Company’s approach of research based on
innovation and vision.
6 Mochida Pharmaceutical Group
•Pharmaceuticals
Mochida Pharmaceutical Co., Ltd.
Mochida Pharmaceutical Co., Ltd. has devoted unstinting effort to developing and marketing a
broad spectrum of innovative new drugs. The Company’s line of proprietary products began with the
development of an agent for ophthalmologic disorders and grew to encompass hormones, enzymes,
and immunological products. Major successes include development of Japan’s first topical antiviral
agent, Arasena-A; one of the world’s first human-derived enzyme inhibitors, Miraclid; and natural
interferon preparations in the field of biotechnology. In the area of diagnostic reagents, the Company
developed Japan’s first pregnancy test kit, Gonavis, and reagents based on monoclonal antibodies for
use in the diagnosis of cancer.
One of the main objectives of the Company is to make solid contributions to business
performance through marketing efforts for its drugs, including the sector’s leading drug for
hyperlipidemia (Epadel). One main focus for the future will be on treatment and medical care for
cardiovascular diseases, including hyperlipidemia. As a result, we expect to achieve steady growth.
Mochida Pharmaceutical Plant Co., Ltd.
Mochida Pharmaceutical Plant Co., Ltd. (MPP) is engaged in contracted manufacturing of
pharmaceutical products. The Head Office Plant manufactures injectable, solid (oral), and topical
medicines. Due to their complex nature, injectable solutions are manufactured using the latest
technology under FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency)
quality control standards.
•Skin Care Products
Mochida Healthcare Co., Ltd.
Mochida Healthcare Co., Ltd. (MHC) is able to draw on its extensive experience in the development of
pharmaceuticals to create skin care products for the general public, and these are supplied through
pharmacies and drugstores. The quality and reliability of the firm’s skin care products are widely
recognized by physicians and pharmacists, as well as consumers. Our skin care products business is
currently expanding product lines to meet growing demand for products in this field. Efforts are also
focusing on increasing awareness of the Collage and Skina brands.
Strengthening Business Foundations through Partnerships
The companies of the Mochida Pharmaceutical Group are doing everything possible to achieve the
Group’s aim of making significant contributions to the improvement of human health and welfare as
a comprehensive healthcare corporate group. While working to strengthen the
foundations for the sustainable growth of each business, we also emphasize the
importance of partnerships with other companies to effectively complement and
reinforce our businesses.
Mochida Pharmaceutical Plant Co., Ltd.
Head Office Plant
Mochida Pharmaceutical Group 7
Research & Development
Developing Innovative
New Medicines for Tomorrow
Mochida Pharmaceutical’s principal aim is to contribute to the health of the
community by bringing innovative new drugs to market. The motivating force behind
all Company endeavors begins with the initial quest for useful pharmaceuticals
and continues through the often-lengthy R&D phase right up to the actual market
launch of the product. Mochida Pharmaceutical applies to all R&D projects its
unique resources, comprised of a broad spectrum of technical and developmental
expertise cultivated over the years and an approach based on insight and originality.
Work starts with an initial stage of probative studies and research. For successful
products, the process culminates with clinical development and marketing.
As of May 13, 2011
Code
MTD-39
Name
imiquimod
Indications
Actinic keratosis
Formulation
Topical
Stage
Submitted
MD-0901 mesalazine
Ulcerative colitis
Oral
Phase III
AJH801
Hypertension
Oral
Phase III
Injection
Phase II/III
FSK0808 G-CSF
Pulmonary arterial
hypertension
Neutropenia
Injection
Phase II/III
MND-21 ethyl icosapentate
Non-alcoholic steatohepatitis Oral
MR-20V
ulinastatin
MJR-35
dienogest
Threatened Premature
Delivery
Uterine adenomyosis
JR-031
Human Mesenchymal GVHD
Stem Cells
cilnidipine/valsartan
combination
MD-0701 treprostinil
8 Mochida Pharmaceutical Group
Phase II
Vaginal suppository Phase II
Oral
Injection
Remarks
Licensed-in from iNova
Pharmaceuticals (Australia)
Licensed-in from Shire
Pharmaceuticals Group (UK)
Co-development with Ajinomoto
Pharmaceuticals
Originator: United Therapeutics
(USA)
Biosimilar (Follow-on biologics)
Co-development with Fuji Pharma
Suspended
Early Phase II Licensed-in from Jenapharm
(Bayer Pharma AG)
Phase I/II
Cellular-based Drug
Co-development with JCR
Rapid Development of New Medicines Used Worldwide
With its extensive technical resources and expertise, Mochida Pharmaceutical has established itself
as a leader in developing pharmaceuticals utilizing natural bioactive substances, with successes in the
development of Thrombin, Uronase, Miraclid, IFN Mochida, Epadel, and other products. To enable
more rapid development of medicines for use throughout the world, we are currently focusing on
research efforts in the fields of diabetes, obesity, and chronic pain, utilizing the latest in computer and
high-throughput screening techniques.
Overeating and sedentary lifestyles in developed countries have resulted in an accelerating
increase in the number of people suffering from metabolic syndrome and diabetes. Given that these
symptoms can ultimately lead to atherosclerotic disease, providing prevention and treatment methods
for obesity and diabetes is an important mission for a healthcare company.
Mochida is creating candidate substances for diabetes medicine, and introducing them worldwide.
Worldwide, 75−80 million people suffer from chronic pain; many of them reported that pain
had deleterious effects on their mental health, employment status, sleep, and personal relationships.
The impact of pain on patient QOL and the unmet needs in pain management were fully recognized
by physicians and healthcare companies. With an aging population and the simultaneous rise in the
conditions that lead to chronic pain, along with the need for better efficacy and safety profiles, new
therapeutics need to be developed.
Mochida Pharmaceutical is also conducting Phase I clinical trials on an oral transient receptor
potential vanilloid sub type 1 (TRPV1) receptor antagonist invented by Mochida Pharmaceutical as a
potential treatment for pain.
Extensive Links with Outside Research Organizations
We are introducing and utilizing new technologies to provide effective medicines for patients as quickly
as we can. Mochida Pharmaceutical has achieved many tangible results, not only in its in-house
research but also through joint research frameworks with external research organizations. These
include joint research with the Osaka Bioscience Institute on apoptosis (programmed physiological cell
death needed to remove unnecessary cells within the body). The research effort bore fruit in patents
on a Fas/Fas Ligand system, and Mochida Pharmaceutical is now licensing the patents to a number of
pharmaceutical companies. Such joint research with and connection to other research organizations is
seen as critical in increasing the pace at which medicines are created.
As a member of the Pharmaceutical Consortium for Protein Structure Analysis, Mochida
Pharmaceutical has since 2002 utilized “SPring-8,” a large-scale synchrotron radiation facility that
operates at the world’s highest level of performance, to analyze the three-dimensional structure of
target molecules and data on the bonding of therapeutic agents and their target. In addition, we are
working to lay the foundation for boosting the probability of successful drug discovery, primarily by
improving the environment for the usage of advanced research facilities in cooperation with academia
through the Consortium.
Epadel: The Outcome of Foresighted, Innovative Research
A drug that epitomizes the unique and innovative strengths of Mochida Pharmaceutical’s R&D
capabilities is Epadel, a drug for hyperlipidemia and arteriosclerosis obliterans. Epadel is the world’s
first high-purity ethyl icosapentate (EPA-E). Working in cooperation with Nippon Suisan, Mochida
Pharmaceutical made a historical breakthrough by turning purified EPA-E into a pharmaceutical. A
global epidemiological study on the relationship between diet and disease has found that people who
consume EPA as part of their diet are much less likely to suffer from such diseases as high blood
pressure and arteriosclerosis-induced myocardial infarction than those who do not consume EPA.
Mochida Pharmaceutical Group 9
Production
Unrivaled Commitment
to Quality
A company operating in the pharmaceutical field must
have advanced technological capabilities, not just
in R&D but in the manufacturing process as well. While coordinating personnel,
facilities, and technology of a high level, Mochida Pharmaceutical Plant Co., Ltd.
(MPP) ensures hierarchical control over manufacturing and quality, from individual
processes to the overall procedures. This is intrinsic to a quality assurance system
designed to ensure that only products of outstanding quality leave the company.
MPP takes a proactive approach to achieving superior quality in all aspects of
operations. It is an approach that demonstrates the company’s indomitable spirit
of originality and research based on a strong vision of the future.
10 Mochida Pharmaceutical Group
State-of-the-Art Manufacturing and Quality Control
In addition to efficacy and safety, high quality is essential to pharmaceutical products, which directly
impact life and health. MPP ensures strict adherence to the quality standards on which marketing
approval is based. It is by observing Good Manufacturing Practice (GMP) that the Company’s
pharmaceutical manufacturing unit has achieved high levels in both manufacturing and quality control.
MPP’s basic approach and a prerequisite for all manufacturing is to introduce products of superior
quality to the market. While ensuring that each employee operates within the scope of these rules,
MPP still maintains it own unique approach and continues to find new ways to achieve better quality.
Utilizing the Latest Advances in “Hardware” and Technology
The Head Office Plant (Otawara) manufactures injectable, solid (oral), and topical medicines.
Conforming to FDA and EMA quality control standards, all phases of production at the Injectable
Medicines building, from receipt of raw materials to the shipping of final products, are managed with
computer systems. MPP utilizes this exacting production system in the manufacture of enzyme,
protein, and biological products and other injectable drugs, processes which require the highest levels
of technology. MPP’s flexible production system further enhances stability in production to cover the
variable order sizes in contract manufacturing, including orders for oral and topical medicines. We
are also actively working to improve packaging technology to prevent misuse of drugs and increase
conformity with universal design.
Extensive Experience in the Development and Manufacture of New Medicines
As a manufacturer working in the development of new medicines, MPP has vast experience in scaling
up manufacturing of products, both those developed in-house as well as through technology transfer,
and has the ability to consult on matters such as industrialization and large-scale production. In
addition, MPP can assist clients investigating any stage of production, from development to contract
manufacturing, applying the Company’s experience in research, development, and pharmaceutical
affairs to provide support in establishing efficient manufacturing processes.
Giving Careful Consideration to Environmental Protection
MPP’s commitment to protecting natural resources, maintaining natural beauty, and preserving the
environment around us is not only a fundamental aspect of the company’s corporate activities, it is
based on the company’s wish to contribute responsibly in its dealings with the larger community. As
part of this awareness, in all its production activities, MPP places great emphasis on careful selection
of raw materials for products, reduction of the
amount of packaging used, and safe and proper
disposal of waste. In recognition of these efforts, in
March 2002 the Head Office Plant (Otawara) was
awarded ISO 14001 certification by the International
Standards Organization for its environmental
management system. This plant, which used heavy
oil as fuel, switched to liquefied natural gas (LNG)
and electricity in March 2009, in an effort to further
reduce the amount of carbon dioxide emissions.
Mochida Pharmaceutical Plant Co., Ltd. / Head Office Plant
Mochida Pharmaceutical Group 11
Licensing Activities
Building Strong Partnerships
Mochida Pharmaceutical actively engages in
alliances with external partners to ensure that we
deliver new medications that improve patients’
lives. Our partnerships extend from research to
marketing, and we value highly these alliances of
excellence as we take on challenges together to
satisfy unmet medical needs.
Strategic
Planning &
Coordination
Licensing
Intellectual
Property
Business Development Division
Functions
12 Mochida Pharmaceutical Group
Collaboration with Other Companies
Mochida Pharmaceutical prioritizes cardiovascular medicine, obstetrics and gynecology, dermatology, and
emergency medicine in its sales resource allocation for its core pharmaceutical business. The antidepressant
Lexapro® (escitalopram) is scheduled to go on sale in 2011, and with this release the Company will focus on the
psychiatric field as an addition to the existing four major areas.
We are strengthening our product pipeline, maximizing product value, and advancing the development of
high-value-added products to meet medical treatment needs and customer needs through numerous domestic
and international partnerships.
For example, sales of Atelec®, the long-acting calcium channel blocker antihypertensive drug licensed by
Ajinomoto Co., Inc., are greatly increasing. Mochida Pharmaceutical has also developed and launched Beselna,
the first condyloma acuminatum treatment in Japan licensed by iNova Pharmaceuticals (Australia) Pty Limited,
and Dinagest, an oral progestin for the treatment of endometriosis licensed by Jenapharm (Bayer Pharma AG).
We are also working on the development of drugs for intractable diseases, including the pulmonary
hypertension treatment under an exclusive distribution license from United Therapeutics Corporation and the
ulcerative colitis treatment licensed by Shire Pharmaceuticals Group (U.K.).
In biopharmaceuticals, Mochida Pharmaceutical is jointly developing Japan’s first therapeutic cellularbased drug against GVHD together with JCR Pharmaceuticals Co., Ltd., and advancing joint development of a
biosimilar G-CSF together with Fuji Pharma.
In December 2010, the Company concluded a long-term comprehensive agreement for collaboration in
biosimilar products with the Hungarian pharmaceutical company Gedeon Richter Plc. for the development and
marketing of Richter's biosimilar product portfolio in Japan, and will now pursue the full-scale development of
the biosimilars business.
In April 2011, the Company obtained approval for the manufacturing and sale of Lexapro® (escitalopram),
which was created by the Danish pharmaceutical company H. Lundbeck A/S and introduced and developed
by Mochida Pharmaceutical. Mochida Pharmaceutical will sell the drug together with Mitsubishi Tanabe Pharma
Corporation, and promote the drug together with Mitsubishi Tanabe Pharma Group company Yoshitomi Yakuhin
Corporation.
Through collaboration with our valuable partners, Mochida Pharmaceutical continues fulfilling our mission
of providing pharmaceutical products to meet unmet medical needs.
Some Collaborations
Novo Nordisk
Bayer HealthCare Pharmaceuticals
Lundbeck
Nippon Suisan
Janssen
Taisho Pharmaceutical
Shire
Ajinomoto
Gedeon Richter
Siemens
KAINOS
Medix
Servier (Egis)
United Therapeutics
MOCHIDA
MOCH
UCB
Fuji Pharma
Sanofi Aventis
Unitika
JCR
Mitsubishi Tanabe Pharma
iNova Pharmaceuticals
Mochida Pharmaceutical Group 13
Pharmaceuticals
Pharmaceuticals That Contribute to the
Communities in Which We Live
A pharmaceutical company’s work does not
end when the product is successfully launched.
Drugs must be used properly in order to be
fully effective. This means that there must be a
process for providing appropriate information
on drugs to medical institutions, for collecting
feedback from the institutions once the drugs are
in use, and for informing the various institutions
of the Company’s evaluations and responses on
key issues. Mochida Pharmaceutical sees this
type of information-disseminating activity as a
way to further contribute to society.
14 Mochida Pharmaceutical Group
Cardiovascular
medicine
Obstetrics
and
Gynecology
Dermatology
Psychiatry
Emergency
Medicine
Key Therapeutic Areas
Producing Products with Beneficial Effects Tailored to Specific Fields
•Cardiovascular medicine
Epadel is the first drug in the world in which EPA-E (ethyl icosapentate: one of the poly-unsaturated fatty
acids contained in fish oil) was successfully extracted and purified to a high degree. This drug has opened
up a new field in the treatment for arteriosclerosis obliterans and hyperlipidemia. Atelec®, a calcium channel
blocker that is presently considered the first choice for the treatment of high blood pressure, begins to work
gradually in the morning and has a long-acting effect on lowering blood pressure during the day. Atelec® is a
dual L/N type calcium channel blocker which, unlike regular L type channel blockers, has the unique property
of also providing a renoprotective effect. Rocornal has a track record of more than 20 years of achievement in
the cardiovascular field, and has established itself firmly as a treatment drug for angina pectoris.
•Obstetrics and Gynecology
Mochida Pharmaceutical has traditionally placed strong emphasis on the Ob/Gyn area, where it has built
an impressive record with hormonal preparations and pregnancy test kits. Estriel is widely recognized for
the treatment of post menopausal disorders, vaginitis, and geriatric osteoporosis. Some other examples
are Mochida Pharmaceutical’s Ortho® 777-21 and Ortho® M-21, a low-dose triphasic oral contraceptive and
a low-dose monophasic oral contraceptive, and Grandaxin, which has been used for autonomic dystonia,
a common symptom of menopausal syndrome. The launch of Dinagest, a novel oral progestin, in January
2008 has expanded medication for patients suffering from endometriosis, in addition to Suprecur®, a GnRH
analogue.The Company is presently conducting clinical trials on Dinagest to confirm its effectiveness for
treating uterine adenomyosis as an additional indication.
Epadel (ethyl icosapentate)
Epadel is the world’s first ethical drug
containing high-purity ethyl icosapentate
extracted from fish oil. It is used for treating
arteriosclerosis obliterans and hyperlipidemia.
A capsule formulation, seamless capsule, was
added in 1999.
Atelec® (cilnidipine)
Atelec® is a dual L/N type calcium channel blocker
with a long-acting hypotensive effect that also
provides a renoprotective effect.
Rocornal (trapidil)
Rocornal, a coronary vasodilator, has enjoyed
a firm reputation since its launch in Japan in
1979, as a drug for angina pectoris.
Ortho® 777-21 and Ortho® M-21
(norethisterone, ethinylestradiol)
Ortho® 777-21 is a low-dose triphasic oral
contraceptive. Ortho® M-21 is a low-dose
monophasic oral contraceptive.
Suprecur® (buserelin)
Suprecur®, a GnRH analogue, is used for
treating endometriosis, precocious puberty, and
uterine myoma. Nasal spray and micro particle
injection are available.
Dinagest (dienogest)
Dinagest is a novel and oral therapeutic agent
for endometriosis that activates selectively
progesterone receptors, and demonstrates its
therapeutic effect by inhibiting ovarian function
and proliferation of endometrial cells.
Mochida Pharmaceutical Group 15
Pharmaceuticals
•Dermatology
Florid®, an antimycotic drug, is a leading product in this area. Mochida Pharmaceutical provides the
topical formulation for dermatomycosis. Arasena-A is the first antiviral drug for the topical treatment
of herpes zoster and herpes simplex to be developed in Japan. Beselna was launched in December
2007 as the first therapeutic agent for condyloma acuminatum (external genital and perianal warts) in
Japan, which gives patients a new treatment option other than surgical therapies.The Company has
applied for approval to use Beselna for the additional indication of actinic keratosis.
•Emergency Medicine
Miraclid has demonstrated excellent clinical efficacy as a drug for treatment of acute circulatory failure caused
by shock, and acute pancreatitis. This drug represents the first commercial application of ulinastatin, which
inhibits various enzyme activities. It reflects Mochida Pharmaceutical’s advanced technological capabilities
in the development of new biologically active agents. Thrombin, a hemostatic agent, and Novo-Heparin, an
anticoagulant agent, are also indispensable drugs to emergency medical care.
Florid® (miconazole)
Florid®-F injection is an antimycotic drug
for treating systemic mycosis. An oral gel
formulation was launched, expanding the
indications to include candidiasis of the oral
cavity and esophagus. Other formulations
include a vaginal suppository and a cream.
Arasena-A (vidarabine)
Arasena-A, an antiviral agent, is used for
treating herpes zoster, herpes simplex, and
herpes simplex encephalitis. Arasena-A
Ointment is the first topical antiviral drug
developed in Japan. Other formulation includes
a cream.
Beselna (imiquimod)
Beselna is the first therapeutic agent for
condyloma acuminatum (external genital and
perianal warts) in Japan.
Miraclid (ulinastatin)
Miraclid, a multivalent enzyme inhibitor,
represents the first ethical drug using ulinastatin
purified from human urine. Its indications are
acute circulatory failure and acute pancreatitis.
Liquid Thrombin MOCHIDA Softbottle
(thrombin)
These new concertina-shaped soft bottles
are designed not only to greatly improve
convenience of application, but also to prevent
fatal medical accidents caused by possible
inadvertent injection of the agent.
Novo-Heparin Injection (heparin sodium)
Novo-Heparin Injection, an anticoagulant
derived from porcine intestinal mucosa, is
indicated for the treatment of disseminated
intravascular coagulation syndrome, and
prevention of thromboembolism.
16 Mochida Pharmaceutical Group
•Psychiatry
The antidepressant Lexapro® (escitalopram), which is scheduled to go on sale in 2011, is a selective
serotonoin reuptake inhibitor (SSRI). Lexapro® is used in over 100 countries worldwide, and has been
highly evaluated overseas as an antidepressant that provides the best possible balance between
efficacy and acceptability. Lexapro® is expected to be well received in Japan as a new treatment
option. With the addition of Lexapro® to our tetracyclic antidepressant Tecipul and our autonomic
dystonia drug Grandaxin, Mochida Pharmaceutical is commited to improving the QOL for psychiatric
patients.
•Diagnostic Reagents
In the field of diagnostic reagents, Mochida Pharmaceutical pioneered immunological diagnostics in
Japan, and developed Gonavis, the nation’s first pregnancy test kit. Since the launch of Gonavis, the
Company has developed a number of products with its own technologies and through joint research
and/or technology transfer with leading overseas companies. Our product lineup includes Gonastick W,
a one-step, stick-type pregnancy test kit; and CanD-Tec, a candida antigen detection test.
Lexapro® (escitalopram)
Lexapro® selectively inhibits the reuptake of
serotonin and has an antidepressant effect. It
provides the best possible balance between
efficacy and acceptability as a first-line therapy
in the treatment of depression.
Grandaxin (tofisopam)
Grandaxin relieves various symptoms
caused by tension imbalances between the
sympathetic and para-sympathetic nervous
systems. It has proved effective in treating a
variety of stress-induced ailments.
Gonastick W
Gonastick W is a pregnancy test kit that
employs immunochromatography, enabling
one-step qualitative detection of human
chorionic gonadotrophin (hCG) at two levels:
higher than 25 IU/L and higher than 1,000 IU/L.
•The Prominence of EBM
Evidence-based medicine (EBM) has become a topic of increasing importance. Mochida
Pharmaceutical has participated in a large-scale clinical trial, the Japan EPA Lipid Intervention Study
(JELIS), investigating whether Epadel can prevent cardiovascular events in hyperlipidemic patients.
In November 2005, the test results were presented in a late-breaking clinical trials session at the
American Heart Association (AHA)’s Scientific Sessions 2005; results showing Epadel significantly
suppressed onset of major coronary events received much attention from experts in the field.
The high regard in which the efficacy of Epadel is held was confirmed in March 2007, when
the study results were presented in the eminent British medical journal, The Lancet (2007, Vol. 369,
pp. 1090–1098). Epadel was also recommended as a pharmaceutical treatment in the guidelines for
treating atherosclerosis issued by the Japan Atherosclerosis Society in April 2007. A stream of useful
information is being derived from JELIS. Utilizing these results, Mochida Pharmaceutical will provide
beneficial and high-quality information to medical experts.
Mochida Pharmaceutical Group 17
Skin Care Products
Providing Truly
Useful Skin Care Products
In 2004, Mochida’s Skin Care Product Division was
spun off as Mochida Healthcare Co., Ltd. (MHC),
which undertakes the development, production,
and marketing of skin care products.
Employing its extensive expertise acquired
in the development of pharmaceuticals, MHC
specializes in areas of dermatology such as care
for sensitive skin, antimicrobial personal care,
baby care, and nursing products. To ensure that
we provide products for our customers that are
truly useful, we support the development process
with clinical trials in close collaboration with
dermatologists. Our products are sold at specialty
pharmacies and drugstores.
18 Mochida Pharmaceutical Group
Antimycotic
Products
Baby Care
Products
Skin Care
Products
Nursing Care
Products
Developing Products
Based on Dermatological Research
Truly Essential Products
MHC’s mission is to develop useful products that benefit the community. The Company has extended
its lineup of healthcare products to include various fields related to medicine. MHC’s skin care
products are created to meet real requirements and are based on close cooperation with medical
professionals. The basic prerequisites are that they should be useful and functional.
S-Collagen, a First in Domestic Skin Care Products
MHC’s foresight and originality are evident in the development of the Collage series,
the nation’s first skin care products, containing natural soluble collagen (S-Collagen).
After many years of research based on dermatological science, the Company has
succeeded in developing the Collage S series using “trimethylglycine” to achieve
further improvement of the moisturizing activity of the original Collage series. As
with the original Collage series, Collage S products do not contain fragrances or
coloring agents, so even customers with the most delicate skin can use them
with confidence.
The Company has also responded to the needs of customers with particularly
sensitive skin types who wish to use a whitening treatment. It has developed the
Collage Whitening series, Japan’s first hypoallergenic whitening series for sensitive
skin types. It also began sales of Collage White Peel, a face wash that utilizes the
power of enzymes to exfoliate dead skin cells. The Company is focusing on product
development that responds to changing customer needs. For example, it has
released a hypoallergenic soap series, which provides a choice of products suited
to a range of skin types and uses.
Medically Based Technology and Experience
MHC’s dermatological products, including Collage soap, a non-irritating soap
formulated for each specific skin type, and the Collage D series, moisturizing
products for dry skin, enjoy a high reputation among consumers for their
effectiveness. The Company provides customers suffering from dandruff and itchy
scalp with Collage Furfur, the first shampoo in Japan containing an antimycotic
agent. MHC now also provides an antibacteriological series, with hair conditioner and
liquid soap in addition to shampoo. Through these products, MHC will continue to
better the QOL for people with skin problems.
Collage S series
Collage Whitening series
From Baby Care to Geriatric Care
In the field of baby care products, Skina Babe, having the biggest share in baby
bath oil, has continued to protect infants’ skin since it was introduced 40 years
ago. From these early days, MHC has also been developing products for senior
citizens, and these will become even more necessary in the future. The Company
markets Skina Fukifuki and Skina Clen, skin cleansing and bed bath products, and
Skina Dry Shampoo, a foam-type hair shampoo that eliminates the need for rinsing.
These products contribute to the betterment of nursing care for the bedridden. The
Company aims to continue developing products that will be beneficial to the skin
care of every generation.
Collage Furfur series
Skina Babe and Skina series
Mochida Pharmaceutical Group 19
Nutraceuticals
Supporting a Healthy Life with
High-Quality Nutritional Supplements
Aiming to be a comprehensive healthcare provider,
Mochida Pharmaceutical is developing nutritional
supplements as a new line of business. We select
raw materials based on expertise acquired through
our drug research and development and offer
products that have been manufactured with strict
attention to quality. Mochida Pharmaceutical
continues to explore opportunities in new areas.
Vitacollage Series
The Vitacollage series employs high-quality raw
materials and carefully selected combinations
of ingredients. Reflecting heightened interest in
lifestyle habits, the Vitacollage series provides
an extensive lineup of supplements which help
improve dietary balance, enhance beauty, and
maintain health, including Peccoriina, which is a
new easy-to-use nutritional supplement specially
suited to people who are dieting or careful about
excessive carbohydrate intake.
20 Mochida Pharmaceutical Group
Vitacollage series
Main Product Listing
Ethical Drugs
Cardiovascular Agents
•Epadel [ethyl icosapentate] (capsule)
Arteriosclerosis obliterans, Hyperlipidemia
•Rocornal [trapidil] (tablet, fine granule)
Angina pectoris
•Atelec® [cilnidipine] (tablet) Hypertension
Anti-Infectives
•Florid® [miconazole] (injection, vaginal
suppository, ointment, oral gel) Mycosis
•Arasena-A [vidarabine] (injection, ointment,
cream) Herpes zoster, Herpes simplex,
Herpes simplex encephalitis
•Isoprinosine® [inosine pranobex] (tablet)
Subacute sclerosing panencephalitis (SSPE)
•Francetin [fradiomycin sulfate] (powder)
Antibiotic
•Beselna [imiquimod] (cream) Condyloma
acuminatum
Neurological Agents
•Grandaxin [tofisopam] (tablet, fine granule)
Autonomic dystonia
•Tecipul [setiptiline maleate] (tablet)
Depression
•Lexapro® [escitalopram] (tablet) Depression
Hormone Preparations
•Estriel [estriol] (tablet, vaginal tablet, depot
injection) Hormone replacement therapy
(HRT), Osteoporosis
•Desopan® [trilostane] (tablet) Antiadrenal
cortical hormone
•Ortho® 777-21/M-21 [norethisterone,
ethinylestradiol] (tablet) Oral contraceptive
•HCG Mochida [human chorionic
gonadotropin] (injection) hCG
•Suprecur® [buserelin] (nasal spray, micro
particle injection) Endometriosis, Precocious
puberty, Uterine myoma
•Dinagest [dienogest] (tablet) Endometriosis
•Divigel® [estradiol] (gel) Menopausal
symptoms such as hot flash treatment and
hydrosis
•Novo-Heparin [heparin sodium] (injection)
Thrombosis
•Uronase [urokinase] (injection) Acute
myocardial infarction
Diagnostic Reagents
Reagents for Fertility/Infertility
•Gonastick25 (hCG)
•Gonastick W (hCG)
Other Reagents
•CanD-Tec (Candida antigen)
Skin Care Products
Mochida Healthcare Co., Ltd.
Collage Series
Face and Body Care
• Collage S Skin Care series
(Moisture lotion, essence, moisture milk,
cream, UV protection, cleansing)
• Collage Whitening series
• Collage Soap series
• Collage Hand Moisture
• Collage D Body Cream
• Collage D Bath Moisture
• Collage Furfur Soap series
Hair Care
• Collage Furfur series
(Shampoo for dandruff and conditioner)
• Collage Shampoo S
• Collage Rinse S
• Collage Rich (Hair growth tonic for women)
Skina Babe and Skina Series
• Skina Babe (Baby bath oil)
• Skina (Cleanser)
• Skina Clen (Gentle skin cleanser)
• Skina Fukifuki (Cleanser)
• Skina Dry Shampoo
Nutraceuticals
•Vitacollage series (Nutraceutical)
Biological Preparations
•Miraclid [ulinastatin] (injection) Acute
circulatory failure, Acute pancreatitis
•Thrombin Mochida [thrombin] (liquid, fine
granule) Hemostatic
Mochida Pharmaceutical Group 21
Highlights of Our Growth
Ryokichi Mochida
Nobuo Mochida
Ei Mochida
22 Mochida Pharmaceutical Group
1913
Mochida was established by Ryokichi Mochida, and started production and marketing
of Luestin (antiluetic) and Ogoko (ophthalmic ointment).
1918
The Company was renamed Mochida Pharmaceutical Company.
1930
Pelanin (first estrogen preparation developed in Japan)
1945
The Company was incorporated.
1951
Sprase (first hyaluronidase preparation developed in Japan)
1954
Began overseas marketing with exports to Taiwan.
1956
Thrombin Mochida (hemostatic enzyme)
1959
Transferred focus of sales strategy to obstetrics and gynecology.
1962
Established the Immunology Division.
1963
Listed on the Second Section of the Tokyo Stock Exchange (TSE).
1964
Nobuo Mochida was appointed president.
Gonavis (Japan’s first immunological pregnancy test kit); Kimotab (anti-inflammatory)
1967
Completed the Research Laboratory in Oji.
1970
Established the Paramedical Division.
Gonavislide (pregnancy test kit); Uronase (fibrinolytic); Skina Babe (baby bath oil)
1972
Established the Medical Electronics and Equipment Division.
Completed the Shizuoka Plant.
1975
Listed on the First Section of the TSE.
1976
Completed the new headquarters office building in Yotsuya.
1978
Received a Noteworthy Invention Testimonial from the Science and Technology Agency for
the Medilaser balance-type surgical laser head.
1979
Rocornal
1980
Developed monoclonal antibody technology for an immunodiagnostic test.
Medilaser-S
1981
Signed an agreement with Hayashibara Biochemical Laboratory, Inc. for joint research of interferon.
1982
Completed the Fuji Central Research Laboratory.
1983
Established the Mochida Memorial Foundation for Medical and Pharmaceutical Research.
1984
Nobuo Mochida was awarded the Medal with Purple Ribbon for research on the first surgical
laser unit developed in Japan.
Arasena-A
1985
Ei Mochida was appointed president.
Miraclid
1986
Florid®-F injection; Grandaxin
1987
Ei Mochida was awarded the Medal with Purple Ribbon for R&D activities on an
immunochemical diagnostic reagent.
1988
Signed an agreement with Taisho Pharmaceutical Co., Ltd., allowing that company to market
Dermarin, an OTC drug for treating dermatomycosis.
Collage Soap series; Isoprinosine®; IFNß Mochida
1989
Finalized agreements with Upjohn Co. for developing and marketing its prostaglandin derivative.
Tecipul
1990
Susumu Watanabe was appointed president.
Concluded a marketing agreement with Matsushita Electric Industrial Co., Ltd. for the
Medilaser-10S fiber-optic carbon dioxide surgical laser unit.
Epadel Capsule 300
1991
Commenced operations at the Otawara Plant.
Concluded agreement of an antimycotic agent with Imperial Chemical Industries, PLC.
Mammotec
1992
Signed agreements with Ostex International, Inc. for the commercialization and marketing of
Osteomark®; and with Yokogawa-Hewlett-Packard, Ltd. to market an obstetric care unit.
Arasena-A Ointment; Thrombin Oral Fine Granules; Bathquina
Commenced J-MIC (EBM study for Rocornal).
1993
Florid® Oral Gel; Sonotec-IV; Collage Liquid Soap
1994
Additional indication for Epadel (for hyperlipidemia) was approved.
Miraclid liquid formulation for injection
1995
Signed agreements with Smithkline Beecham Seiyaku K.K. for the co-marketing of Arasena-A.
1996
Signed agreements with Norian Corporation for the development and marketing in Japan of
Norian SRS®; and with Dainippon Pharmaceutical Co., Ltd. for the co-marketing of Epadel
in Japan.
Commenced JELIS (EBM study for Epadel).
1997
Concluded distribution agreement with Ajinomoto Co., Inc. for Atelec®.
Atelec®; Gonastick
1998
Co-marketed Dainippon Pharmaceutical’s Cetapril® (ACE inhibitor).
Osteomark®; Amtec
1999
Naoyuki Mochida was appointed president.
Concluded distribution agreement with Janssen Kyowa Co., Ltd. for Ortho® 777-28/M-21;
licensed a patent of Fas/FasL (for gene therapy) to Novartis.
Licensed a patent of Fas/FasL (for screening) to Bristol Myers Squibb.
Epadel S 300 and 600; Collage Furfur; Miotecter®
2000
Signed agreements with RIKEN for co-research in structural genomics.
2001
Signed agreements with 3M for the development and marketing of Aldara.
Arasena-A 3% cream; Gonastick25; Collage Essence
2002
Signed agreements with Aventis Pharma Ltd. for the distribution and co-promotion of
Suprecur®; and with Lundbeck A/S for the co-development and co-marketing of escitalopram.
Established the nutraceutical business.
Obtained ISO 14001 certification for the Otawara Plant.
Suprecur®
2003
Signed agreements with Novo Nordisk for the distribution of Novo-Heparin; and with Medix
Biochemica Oy and Unitika Ltd. for the distribution of a diagnostic test kit for acute
pancreatitis.
Started operation of Mochida Medical Systems Co., Ltd.
Thrombin Mochida Soft bottle; Novo-Heparin; Collage S series
2004
Started operation of Mochida Healthcare Co., Ltd.
Started operation of Mochida Siemens Medical Systems Co., Ltd.
Epadel S 900
2005
Started operation of Mochida Pharmaceutical Plant Co., Ltd.
2006
Collage Furfur Liquid Soap; Collage Furfur S
2007
Signed agreements with JCR Pharmaceuticals Co., Ltd. for co-development and
commercialization of a cellular-based drug; with Novartis Pharma K.K. for co-promotion of
Diovan® (agreement terminated end of 2008); and with United Therapeutics Corporation for
the distribution of Remodulin®.
Beselna Cream 5%
Signed a license agreement with Wyeth Pharmaceuticals Inc. for TRPV1 receptor antagonists
(agreement terminated 2010).
Dinagest; Divigel®; Collage White Peel
2009
Signed a license agreement with Shire Pharmaceuticals Group plc (U.K.) for LIALDA®.
Gonastick W, Collage Furfur Next
2010
Signed agreement with Fuji Pharma Co., Ltd. for co-development of G-CSF; and with
Mitsubishi Tanabe Pharma Corporation for co-marketing of Escitalopram.
2008
Susumu Watanabe
Naoyuki Mochida
Mochida Pharmaceutical Group 23
Re
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C
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cent
Basic Policy on Corporate Governance
The Mochida Pharmaceutical Group strives to increase its corporate value by placing the fulfillment
of corporate governance and the reinforcement of compliance at the axis of its overall Group
management, to better respond to its stakeholders’ trust and expectations.
As part of measures for fulfilling corporate governance, important management decisions
are made at meetings of the Board of Executive Managing Directors and the Board of Group
Management, which are held weekly respectively, based on the outcome of sufficient discussions
at the Management Policy Meeting. We clearly separate the functions of the Board of Directors
into management decision-making and the supervision of business operations. For the purpose of
expediting management decision-making and business operations, the Group has introduced an
Executive Director (Officer) system.
Governance Structure
Mochida Pharmaceutical put in place the Board of Directors (including Outside Directors) and
the Board of Statutory Auditors (including Outside Statutory Auditors) as organizations under the
Companies Act.
Corporate Governance Structure
Meeting of
Shareholders
Election/Dismissal
Election/Dismissal
Election/Dismissal
Confirmation of Appropriate Execution of Audits
Report
Board of Statutory
Auditors
Full-Time Statutory Auditor
Board of Directors
Representative Director
Audit
Report
Accounting Auditor
Director
Audit
Outside Statutory Auditor
Outside Director
Supervision
Audit
Ethics Committee
Election/Dismissal
Representative Director,
President
Risk Management Committee and
Various Committees
Board of Executive
Managing Directors
Board of Group
Management
Excecutive Director (Officer) Meeting
Executive Director (Officer)
Audit
Internal Audit Department
Corporate Ethics
Promotion Department
Each Department and Group Company
24 Mochida Pharmaceutical Group
Management Policy Meeting
Compliance Promotion
As reasons for adopting this governance structure, considering the Company’s size and
business nature, we judged that at this point in time, the most suitable governance structure (1) to
ensure the appropriate function of checking the management and (2) to pursue management efficiency
simultaneously requires: (1) management decision-making by the Board of Directors with a reasonable
number of members, comprising Inside Directors with thorough knowledge of the Company and its
business and Outside Directors with abundant knowledge and experience in specialized fields, and (2)
the system for checking the management by Statutory Auditors including Outside Statutory Auditors.
Internal Control System, Risk Management System, Compliance System, and CSR
The Mochida Pharmaceutical Group constructs, maintains, and evaluates its internal control system
based on resolutions by the Board of Directors under the Companies Act and on the Financial
Instruments and Exchange Act. Specifically, we maintain a companywide risk management system
based on the “Mochida Pharmaceutical Group Risk Management Rules” to manage major risks
affecting our overall business, as part of our internal control system based on the Companies Act.
As measures for reinforcing compliance, we maintain our compliance system by (1) establishing
“Code of Conduct of Mochida Pharmaceutical Group”, (2) holding regular meetings of the Ethics
Committee which includes outside experts, (3) establishing the Corporate Ethics Promotion
Department etc.; and we run regular training programs on compliance for our group employees.
The Mochida Pharmaceutical Group will continue striving to ensure full compliance, and to respond
promptly to various environmental changes, by receiving appropriate advice from our attorneys and
Accounting Auditor as necessary etc.
While the concerned departments are earnestly addressing Corporate Social Responsibility
(CSR), we have also established the CSR Promotion Liaison Committee as a basic body to promote
CSR throughout the Mochida Pharmaceutical Group and to meet more precisely the social demands.
Audit Structure
Mochida Pharmaceutical has established the Internal Audit Department as an organization which
implements internal audits of the Pharmaceutical Business (Sales) Division, Research Division and
other divisions as necessary.
To secure lawfulness and transparency of management decision-making and business
operations, in accordance with fiscal year auditing policy and plans, each Statutory Auditor strives
to (1) smoothly communicate with Board Directors, the Internal Audit Department etc., (2) collect
the relevant information and (3) improve the auditing environments, attends meetings of the Board
of Directors and other important meetings, and investigates business operations and assets at
the headquarters, main business offices and subsidiaries of Mochida Pharmaceutical—including
supervision and verification of the status of the internal control system, the independence of
the Accounting Auditor and the appropriate execution of audits by the Accounting Auditor.
Mochida Pharmaceutical is also audited by our Accounting Auditor, Deloitte Touche Tohmatsu
LLC, based on the provisions of the Companies Act and the Financial Instruments and Exchange
Act. the Internal Audit Department, Statutory Auditors and Accounting Auditor work closely to secure
effectiveness of the audits.
Mochida Pharmaceutical Group 25
S i x - Ye a r S u m m a r y
Mochida Pharmaceutical Co., Ltd. and Consolidated Subsidiaries
Years ended March 31
Millions of Yen
2009
2010
2011
Years ended March 31
2008
2007
2006
For the Year:
Net sales
¥79,340 ¥78,549
Cost of sales
30,387 29,100
28,503 28,321 29,084 26,789
Selling, general and administrative expenses
37,443 35,500
33,694 34,427 34,586 35,040
Income before income taxes and minority interests 11,509 13,949
Operating Income
12,982 11,824 10,396 8,797
8,155 15,783 13,727 14,153 10,282 8,864
5,913*2 4,973*3
5,836*4 4,376*5 3,932*6
9,869
8,754 8,387 6,030 4,988
Income taxes
2,821*1
Net income
5,333 At Year-End:
¥75,181 ¥ 74,573 ¥ 74,066 ¥ 70,627
Total current assets
¥77,191 ¥73,812
Total current liabilities
23,099 21,050
21,439 20,456 21,812 19,784
Working capital
54,092 52,762
46,678 48,831 45,997 44,395
Total tangible fixed assets
17,630 18,036
18,805 17,934 19,172 19,329
Total long-term liabilities
7,348 6,027
6,752 8,959 12,131 13,081
Minority interests
– –
– – – 615
Total net assets*7
78,129 79,768
74,151 74,113 75,763 72,763
Total assets
108,577 106,845 102,344 103,528 109,707 106,245
¥68,118 ¥ 69,287 ¥ 67,810 ¥ 64,180
Other Statistics:
Capital expenditures
¥ 1,977 ¥ 1,757
¥ 3,272 ¥ 1,286 ¥ 2,280 ¥ 1,105
Yen
Per Share Data:
Net income
¥48.4 ¥86.9
¥75.3 ¥ 69.8 ¥ 48.9 ¥ 39.6
Cash dividends
22.0 25.0
22.0 20.0 17.0 12.0
1,727
1,702 1,692 1,792 1,762
Number of employees
Number of shares outstanding at end of year
119,000 123,000
1,721 125,800 125,800 131,223 137,223
*1: As a result of tax effect accounting, corporate tax, resident tax and business tax (total ¥4,284 million), an income tax adjustment (-¥1,462 million) is included.
*2: As a result of tax effect accounting, corporate tax, resident tax and business tax (total ¥5,506 million), an income tax adjustment (+¥407 million) is included.
*3: As a result of tax effect accounting, corporate tax, resident tax and business tax (total ¥5,022 million), an income tax adjustment (-¥49 million) is included.
*4: As a result of tax effect accounting, corporate tax, resident tax and business tax (total ¥5,345 million), an income tax adjustment (+¥491 million) is included.
*5: As a result of tax effect accounting, corporate tax, resident tax and business tax (total ¥4,381 million), an income tax adjustment (-¥5 million) is included.
*6: As a result of tax effect accounting, corporate tax, resident tax and business tax (total ¥3,972 million), an income tax adjustment (-¥39 million) is included.
*7: The amount of total net assets at March 31, 2006 represents the value of total shareholders’ equity.
26 Mochida Pharmaceutical Group
Consolidated Statement of Income / Consolidated Statements of Comprehensive Income (Unaudited)
Mochida Pharmaceutical Co., Ltd. and Consolidated Subsidiaries
For the years ended March 31
Years ended March 31
Net Sales
Cost of Sales
Gross profit
Selling, General and Administrative Expenses
Operating income
Other Income (Expenses):
Interest and dividend income
Interest and discount expenses
Royalty income
Real estate rent
Loss on disposal of inventory
Equity in net losses of affiliated company
Others
Thousands of
U.S. Dollars
Millions of Yen
Consolidated Statements of Income (Unaudited)
2011
¥ 79,340
30,387
48,952
37,443
11,509
2010
¥ 78,549
29,100
49,449
35,500
13,949
2009
¥ 75,181
28,503
46,677
33,694
12,982
2011
$ 954,181
365,457
588,723
450,308
138,414
Recurring income
234
(71)
166
75
–
–
103
508
12,017
253
(141)
910
78
–
(230)
100
971
14,921
297
(58)
584
81
(156)
(236)
67
579
13,561
2,819
(863)
2,003
909
–
–
1,249
6,118
144,533
Extraordinary Gains (Losses):
Gains on sales of affiliated company stock
Gain on reversal of allowance for doubtful accounts
Compensation income
Profit on sales of property, plant and equipment
Loss on sales and disposal of fixed assets
Loss on impairment of fixed assets
Loss on disaster
Revaluation of investments in securities
–
4
–
4
(50)
–
(3,093)
(174)
1,139
0
–
0
(102)
(157)
–
–
–
–
230
59
(119)
–
–
–
–
48
–
54
(607)
–
(37,199)
(2,102)
(2,282)
(2,669)
(1,692)
(46,452)
98,080
33,933
–
$64,147
Loss on adjustment for changes of accounting standard for
asset retirement obligations
(189)
(221)
(140)
(3,862)
Income before income taxes and minority interests
Income taxes
Minority interests
Net income
8,155
2,821 *1
–
¥5,333
Special retirement expenses
Others
Years ended March 31
Total comprehensive income attributable to:
Owners of parent
Minority interests
–
(5)
165
15,783
5,913*2
–
¥9,869
13,727
4,973*3
–
¥8,754 )
–
Thousands of
U.S. Dollars
Millions of Yen
Consolidated Statements of Comprehensive Income
Income before minority interests
Other comprehensive income,net of tax
Valuation difference on available for sale securities
Total:Other comprehensive income,net of tax
Total comprehensive income
–
(19)
862
–
2011
¥ 5,333
2010
2011
–
$64,147
(793)
(793)
4,540
–
–
–
(9,538)
(9,538)
54,608
4,540
–
–
–
54,608
-
*1: As a result of tax effect accounting, corporate tax, resident tax and business tax (total ¥4,284 million), an income tax adjustment (-¥1,462 million) is included.
*2: As a result of tax effect accounting, corporate tax, resident tax and business tax (total ¥5,506 million), an income tax adjustment (+¥407 million) is included.
*3: As a result of tax effect accounting, corporate tax, resident tax and business tax (total ¥5,022 million), an income tax adjustment (-¥49 million) is included.
Note: Unless otherwise indicated, all dollar figures herein refer to U.S. currency. Yen amounts have been translated into U.S. dollars, for convenience only, at the rate
of ¥83.15 = $1.00, the approximate exchange rate on March 31, 2011.
Mochida Pharmaceutical Group 27
Re
C
o sn es ao rl c
i dha &
teD
d eBv ae ll ao np cmee nS th e e t s ( U n a u d i t e d )
Mochida Pharmaceutical Co., Ltd. and Consolidated Subsidiaries
March 31
Thousands of
U.S. Dollars
Millions of Yen
2010
2011
2011
ASSETS
Current Assets:
Cash and time deposits
¥ 24,538
¥ 24,633
$295,106
Notes and accounts receivable
25,271
23,672
303,931
Marketable securities
9,325
9,321
112,154
Inventories
10,670
11,672
128,332
Deferred income taxes
4,503
2,829
54,158
Other current assets
2,882
1,687
34,661
Allowance for doubtful accounts
Total current assets
77,191
73,812
928,345
Buildings and other structures
7,248
7,216
87,174
Machinery and equipment and transportation equipment
3,103
2,724
37,328
Land
6,093
6,088
73,279
Construction in progress
127
694
1,531
Others
1,057
1,311
12,715
Intangible fixed assets
1,167
1,404
14,037
Total fixed assets
18,797
19,441
226,067
Investments in securities
7,289
8,805
87,672
Deferred income taxes
3,258
2,893
39,183
Long-term guarantee deposits and other investments
2,039
1,893
24,531
Total investments and other assets
12,587
13,591
151,387
Total Assets
¥ 108,577
(0)
(4)
(0)
Fixed Assets:
Property, plant and equipment:
Investments and Other Assets:
¥ 106,845
$ 1,305,799
Note: Unless otherwise indicated, all dollar figures herein refer to U.S. currency. Yen amounts have been translated into U.S. dollars, for convenience only, at the rate
of ¥83.15=$1.00, the approximate exchange rate on March 31, 2011.
28 Mochida Pharmaceutical Group
Thousands of
U.S. Dollars
Millions of Yen
2010
2011
2011
LIABILITIES
Current Liabilities:
Notes and accounts payable
¥ 7,993
¥ 7,396
$ 96,136
Short-term debt
875
500
10,523
Income taxes payable
1,809
3,161
21,755
Reserve
6,163
3,570
74,129
Other current liabilities
6,258
6,422
75,263
Total current liabilities
23,099
21,050
277,808
Long-term loans payable
1,125
–
13,529
Reserve for retirement benefits
4,882
4,929
58,722
Deferred income taxes
147
107
1,775
991
14,344
Long-Term Liabilities:
Other long-term liabilities
1,192
Total long-term liabilities
7,348
6,027
88,372
Total liabilities
30,447
27,077
366,180
Paid-in capital
7,229
7,229
86,950
Capital surplus
1,871
1,871
22,503
Retained earnings
79,494
80,577
956,036
Treasury stock
(10,142)
(10,380)
(121,981)
Total Shareholders’ equity
78,452
79,298
943,509
NET ASSETS
Shareholders’ equity
Valuation and translation adjustment:
Unrealized gain (loss) on available-for-sale securities
(323)
469
(3,889)
Total valuation and translation adjustments
(323)
469
(3,889)
Minority interests
–
–
–
Total net assets
78,129
79,768
939,619
Total Liabilities and Net Assets
¥ 108,577
¥ 106,845
$ 1,305,799
Mochida Pharmaceutical Group 29
Consolidated Statements of Changes in Net Assets (Unaudited)
Mochida Pharmaceutical Co., Ltd. and Consolidated Subsidiaries
For the years ended March 31
Thousands of
U.S. Dollars
Millions of Yen
2010
2011
Shareholders’ equity
Paid-in capital:
Balance at the previous year-end
Change in the fiscal year:
Total change in the fiscal year
Balance at the current year-end
Capital surplus:
Balance at the previous year-end
Change in the fiscal year:
Total change in the fiscal year
Balance at the current year-end
Retained earnings:
Balance at the previous year-end
Change in the fiscal year:
Dividends from surplus
Net income
Disposal of treasury stock
Retirement of treasury stock
Total change in the fiscal year
Balance at the current year-end
Treasury stock:
Balance at the previous year-end
Change in the fiscal year:
Acquisition of treasury stock
Disposal of treasury stock
Retirement of treasury stock
Total change in the fiscal year
Balance at the current year-end
Total shareholders’ equity:
Balance at the previous year-end
Change in the fiscal year:
Dividends from surplus
Net income
Acquisition of treasury stock
Disposal of treasury stock
Retirement of treasury stock
Total change in the fiscal year
Balance at the current year-end
Valuation and translation adjustments:
Unrealized gain (loss) on available-for-sale securities:
Balance at the previous year-end
Change in the fiscal year:
Net changes of items other than shareholders’ equity
Total change in the fiscal year
Balance at the current year-end
Total net assets
Balance at the previous year-end
Change in the fiscal year:
Dividends from surplus
Net income
Acquisition of treasury stock
Disposal of treasury stock
Net changes of items other than shareholders’ equity
Total change in the fiscal year
Balance at the current year-end
2011
¥ 7,229
¥7,229
$ 86,950
–
7,229
–
7,229
–
86,950
1,871
1,871
22,503
–
1,871
–
1,871
–
22,503
80,577
75,889
969,063
(2,779)
5,333
(0)
(3,636)
(1,083)
79,494
(2,626)
9,869
(1)
(2,552)
4,688
80,577
(33,425)
64,147
(10)
(43,738)
(13,027)
956,036
(10,380)
(10,675)
(124,837)
(3,421)
22
3,636
237
(10,142)
(2,308)
51
2,552
295
(10,380)
(41,150)
267
43,738
2,855
(121,981)
79,298
74,314
953,680
(2,779)
5,333
(3,421)
21
–
(845)
78,452
(2,626)
9,869
(2,308)
49
–
4,983
79,298
(33,425)
64,147
(41,150)
257
–
(10,171)
943,509
469
(162)
5,649
(793)
(793)
(323)
632
632
469
(9,538)
(9,538)
(3,889)
79,768
74,151
959,330
(2,779)
5,333
(3,421)
21
(793)
(1,638)
¥ 78,129
(2,626)
9,869
(2,308)
49
632
5,616
¥ 79,768
(33,425)
64,147
(41,150)
257
(9,538)
(19,710)
$ 939,619
Note: Unless otherwise indicated, all dollar figures herein refer to U.S. currency. Yen amounts have been translated into U.S. dollars, for convenience only, at the rate
of ¥83.15=$1.00, the approximate exchange rate on March 31, 2011.
30 Mochida Pharmaceutical Group
Consolidated Statements of Cash Flows (Unaudited)
Mochida Pharmaceutical Co., Ltd. and Consolidated Subsidiaries
For the years ended March 31
Thousands of
U.S. Dollars
Millions of Yen
2010
2011
Cash flows from operating activities:
Income before income taxes and minority interests
Depreciation
Imparement loss
Loss on disaster
Loss on adjustment for changes of accounting standard for asset retirement obligations Special retirement expence
Loss on sales and disposal of fixed assets
Revaluation of investments in securities
Gain on sales of investment securities
Investment loss on equity method
Decrease in doubtful accounts
Decrease in reserve for bonuses
Decrease (increase) in accrued retirement benefits
Increase in reserve for retirement benefits for directors
Interest and dividend income
Interest and charge (commission) expense
Loss (gain) on foreign exchange
(Increase) decrease in accounts receivable – trade
Decrease in inventories
Increase in other current assets
(Decrease) increace in accounts paybable
(Decrease) increase in other current liabilities
Other
Subtotal
Interest and dividends received
Interest and commission paid
Payments for loss on disaster
Payments for special retirement expenses
Income taxes paid
Net cash provided by operating activities
Cash flows from investing activities:
Payments into time deposits
Proceeds from refunds on time deposits
Payment for purchases of tangible and intangible fixed assets
Loss on sales of property, plant and equipment
Proceeds from sale of shares in affiliates following change in scope of consolidation Other
Net cash used in investing activities
Cash flows from financing activities:
Proceeds from long-term loans payable
Repayment of long-term debt
Dividends paid
Payment for acquisition of treasury stock
Proceeds from disposal of treasury stock
Other
Net cash used in financing activities
Effect of Exchange Rate Changes on Cash and Cash Equivalents Increase (Decrease) in Cash and Cash Equivalents
Cash and Cash Equivalents at Beginning of Year
Cash and Cash Equivalents at End of Year
2011
¥ 8,155
2,866
–
3,093
189
221
46
174
–
–
(4)
(6)
(49)
3
(234)
71
(0)
(1,599)
857
(1,183)
597
(38)
(435)
12,726
237
(76)
(175)
(50)
(5,599)
7,061
¥ 15,783
2,828
157
–
–
–
101
–
(1,139)
230
(0)
(1)
101
0
(253)
141
0
16
800
(187)
(293)
108
(766)
17,628
256
(134)
–
–
(5,533)
12,217
$ 98,080
34,471
–
37,199
2,282
2,669
553
2,102
–
–
(49)
(77)
(601)
42
(2,819)
863
(0)
(19,231)
10,315
(14,231)
7,188
(468)
(5,240)
153,050
2,859
(921)
(2,109)
(604)
(67,346)
84,928
(7,020)
7,520
(2,458)
5
–
17
(1,935)
(7,120)
7,220
(1,901)
0
1,170
(6)
(638)
(84,425)
90,438
(29,567)
62
–
215
(23,276)
1,500
–
(2,775)
(3,421)
21
(41)
(4,716)
0
409
26,434
¥ 26,843
–
(600)
(2,623)
(2,313)
49
(34)
(5,521)
(0)
6,056
20,377
¥ 26,434
18,039
–
(33,373)
(41,150)
257
(500)
(56,728)
0
4,923
317,911
$ 322,834
Note: Unless otherwise indicated, all dollar figures herein refer to U.S. currency. Yen amounts have been translated into U.S. dollars, for convenience only, at the rate
of ¥83.15=$1.00, the approximate exchange rate on March 31, 2011.
Mochida Pharmaceutical Group 31
Management
Members of the Board
Executive Directors
(As of June 29, 2011)
Kazuhisa Takayanagi
President
Naoyuki Mochida
Senior Executive Managing Directors
Makoto Aoki
Kaoru Sasaki
Pharmaceutical Business
Business Development
Executive Managing Directors
Yasuo Isomura, Ph.D.
Ryuji Deguchi
Business Development
Koichi Funaki
Clinical Research and Development
Hiroshi Nakamura
Quality Assurance
Shouji Furusako, Ph.D.
Research
Kenshi Tomita
Planning and Administration
Research
Clinical Research and Development
Kazuhiro Miyaji
Yoichi Kono
Takayuki Katou
Production
Skincare Business
Tamio Nakamura
Audit and Corporate Ethics
Executive Directors
Akira Hirata, D. Med. Sc.
Clinical Research and Development
Keiichi Sagisaka
Pharmaceutical Business
Chu Sakata
Planning and Administration
Outside Director
Kazumasa Kishi
Corporate Auditors
Hiroshi Ogawa
Takashi Inagaki
Kiyotaka Ishikawa
Hiroshi Watanabe
Tetsuya Kobayashi
32 Mochida Pharmaceutical Group
Corporate Planning
Finance
Business Development
Corporate Data
Founded
Subsidiaries
April 16, 1913
Mochida Pharmaceutical Plant Co., Ltd.
431, Nakadawara,
Otawara, Tochigi 324-0062, Japan
Incorporated
April 28, 1945
Mochida Healthcare Co., Ltd.
Paxxs Building,
2-12, Ichigaya-Honmura cho,
Shinjuku-ku, Tokyo 162-8451, Japan
Paid-in Capital
¥7.2 billion
Stock Exchange Listing
Tokyo Stock Exchange, First Section
Employees
Mochida International Co., Ltd.
Y.S. Building, 9, San-eicho,
Shinjuku-ku, Tokyo 160-0008, Japan
1,721 (Consolidated)
Head Office
7, Yotsuya 1-chome,
Shinjuku-ku, Tokyo 160-8515, Japan
Phone: +81-3-3358-7211
Facsimile: +81-3-3358-7887
Internet Home Page:
http://www.mochida.co.jp/
Technonet Co., Ltd.
7, Yotsuya 1-chome,
Shinjuku-ku, Tokyo 160-8515, Japan
Affiliated Companies and Organizations
•Medical View Co., Ltd.
•Mochida Memorial Foundation for
Medical and Pharmaceutical Research
Research Laboratories
•Pharmaceutical Research Center
(Gotemba, Shizuoka)
•Pharmaceutical Laboratory
(Fujieda, Shizuoka)
“Plaisir”
This sculpture is “Plaisir” (Joy), a work created by the
well-known Japanese artist Taro Okamoto (1911–1996)
for the Company’s 65th anniversary in 1978. “Plaisir”
was named after our wish to be tied to people with joy,
and our joy in contributing to human health and welfare,
as a comprehensive healthcare company.
Mochida’s Head Office
in Tokyo
Mochida Pharmaceutical Group 33
http://www.mochida.co.jp/
Printed in Japan
2011.7