- Sales (-0.9%) and core operating profit
(-2.1%) decreased due to the impact of certain items such as the
transfer of the global dermatology business in April 2016 and the
transfer of long-listed products in Japan in April 2017. Excluding
these items, as well as the impact of foreign exchange, sales
decreased (-1.2%) and core operating profit increased (+4.6%).
- Sales of key global products such as
XTANDI® for the treatment of prostate cancer and Betanis® /
Myrbetriq® / BETMIGA for the treatment of overactive bladder
(“OAB”) grew.
- Operating profit (-18.2%) and profit
for the period (-24.7%) on a full basis decreased mainly due to the
impact of one-time impairment losses and charges associated with
the review of development project plans, including those pertaining
to Ganymed Pharmaceuticals AG, and the termination of research
operations of Agensys, Inc.
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji
Yasukawa, Ph.D., “Astellas” ) today announced the financial results
for fiscal year 2017 ending March 31, 2018 (“FY2017”).
“Key global products including XTANDI®
continued to demonstrate steady growth in FY2017. We also have
made continual investments in the creation of future innovation,
including the acquisition of Universal Cells, Inc. in February
2018. The additional cell therapy capabilities of Universal Cells,
including proprietary Universal Donor Cell technology, enables
Astellas to accelerate our innovative research and development
focus within cell therapy,” said Kenji Yasukawa, Ph.D., president
and CEO, Astellas. “We remain committed to creating medical
solutions from a multi-dimensional perspective – including disease,
biology and modality – to turn innovative science into value for
patients.”
Consolidated Financial Results (April 1,
2017 – March 31, 2018) (core basis)
(Millions of yen)
FY2016
FY2017
Change(%)
Sales 1,311,665
1,300,316
-11,349(-0.9%)
Core operating profit 274,554
268,698
-5,856(-2.1%)
Core profit for the year 213,343
204,326
-9,017(-4.2%)
Sales Highlights
Sales in FY2017 decreased 0.9% compared to those in the previous
fiscal year (“year-on-year”) to ¥1,300.3 billion due to the impact
of certain items such as the transfer of the global dermatology
business in April 2016 and the transfer of long-listed products in
Japan in April 2017.
Sales of XTANDI® increased 16.8% year-on-year to ¥294.3 billion.
Sales grew steadily in all regions of the world.
Sales of Betanis® / Myrbetriq® / BETMIGA increased 27.2%
year-on-year to ¥125.7 billion. Sales increased in all regions of
the world. Sales of Vesicare®, however, decreased 11.9%
year-on-year to ¥102.3 billion.
- Transplantation franchise
Sales of Prograf® increased 6.6% year-on-year to ¥198.5 billion,
and continued to grow in EMEA1 and the Asia and Oceania
regions.
- Other new and key products
In the Japanese market, continued growth was achieved for
products such as Celecox® for the treatment of inflammation and
pain, Symbicort® for the treatment of bronchial asthma, Suglat® for
the treatment of type 2 diabetes, and Cimzia® for the treatment of
adult patients with rheumatoid arthritis. Meanwhile, we have been
working on steadily increasing market penetration for new products
Repatha® for the treatment of hypercholesterolemia (launched in
April 2016) and Linzess® for the treatment of irritable bowel
syndrome with constipation (launched March 2017). In the Americas,
sales of azole antifungal CRESEMBA® grew.
Sales of three main therapeutic areas
(Billions of yen)
FY2016
FY2017 Change Oncology
franchise 307.7
345.2 +12.2%
XTANDI® 252.1
294.3 +16.8% Urology OAB franchise 214.9
228.1 +6.1%
Vesicare® 116.1
102.3 -11.9%
Betanis® /
Myrbetriq® / BETMIGA
98.8
125.7 +27.2% Transplantation franchise 186.2
198.5 +6.6%
Sales by Region2
Sales in Japan and EMEA decreased, while sales in the Americas
and Asia and Oceania increased. As for the Japanese market, sales
decreased 15.3% year-on-year to ¥383.4 billion largely due to the
impact of transferring 16 long-listed products in April 2017, and
the introduction of generics for Micardis® for the treatment of
hypertension in June 2017. In EMEA, sales decreased due to the
continued impact of transferring the dermatology business in April
2016, yet sales increased when excluding this item.
FY2018 Guidance
The forecasts for fiscal year 2018 ending March 31, 2019
(“FY2018”) (core basis) are as shown in the following table. The
sales forecast is ¥1,278.0 billion (- 1.7% year-on-year). Core
operating profit is forecasted at ¥262.0 billion (-2.5%
year-on-year). In FY2018, we expect negative impact on sales and
profit due to a decreased amount of recognized deferred income
following the transfer of the global dermatology business and the
transfer of long-listed products in Japan, foreign exchange, and
other factors. Despite the negative impact of the NHI drug price
revision in Japan and other factors, we are forecasting sales and
core operating profit, excluding the factors associated with
previously discussed business transfers and the impact of foreign
exchange, to remain largely unchanged year-on-year.
Consolidated Full-year Business
Forecasts (core basis)
(Millions of yen)
FY2017
Results
FY2018
Forecasts
Change(%) Sales 1,300,316
1,278,000
-22,316(-1.7%)
Core Operating profit 268,698
262,000
-6,698(-2.5%)
Core Profit for the year 204,326
210,000
+5,674(+2.8%)
NOTE: For further information on the results including on
a full basis, please refer to the reference documents: Financial
Results, Supplementary Documents, Overview of R&D Pipeline and
Presentation Material for the Financial Information Meeting
available on the Astellas website at
https://www.astellas.com/en/investors/ir-library.
Strategic Highlights in FY2017
Astellas continues to create sustainable growth over the
mid-to-long term through the pursuit of three main strategies:
“Maximizing the Product Value,” ”Creating Innovation” and “Pursuing
Operational Excellence.” The company achieved many accomplishments
against these strategies as outlined below:
Maximizing the Product Value
- Continued to maximize the growth of the
Oncology franchise centered on XTANDI® and the Urology OAB
franchise including Vesicare® and Betanis® / Myrbetriq® / BETMIGA®
with new launches across various countries and a growth in
franchise sales globally.
- In January 2018, Amgen Astellas
BioPharma K.K. launched sales in Japan of the Repatha® SC injection
420 mg Auto Mini Doser, an additional dosage formulation of
Repatha®.
- In November 2017, executed a
co-promotion agreement in Japan with MSD K.K. for SUJANU®
Combination Tablets, a combination drug of the DPP-4 inhibitor
sitagliptin phosphate hydrate (JANUVIA® Tablets) and Suglat®
Tablets.
Creating Innovation
The following are highlights of developments with external
partners announced during FY2017.
- In April 2017, the Alliance Station was
opened by Astellas and Kyoto University as part of a new open
innovation initiative to develop advanced medical treatments.
- In May 2017, completed the acquisition
of Ogeda SA in Belgium and gained the NK3 receptor antagonist
fezolinetant (ESN364), which is in development for
menopause-related vasomotor symptoms.
- In May 2017, signed an agreement to
broaden the scope of an existing collaborative research agreement
with the Institute of Medical Science of the University of Tokyo
utilizing the MucoRice rice-based oral vaccine. Furthermore, in
December 2017, a collaborative research agreement was signed aiming
at the practical application of the rice-based oral vaccine
MucoRice-CTB with the Institute of Medical Science of the
University of Tokyo, Chiba University, and ASAHI KOGYOSHA CO.,
LTD.
- In October 2017, launched “JOINUS,” a
new drug discovery program using a drug-repositioning compound
library jointly conducted by Astellas, Mitsubishi Tanabe Pharma,
and Daiichi Sankyo.
- In October 2017, entered into an
exclusive worldwide license agreement with Universal Cells Inc. for
the worldwide research, development, and commercialization of new
cell therapies and acquired Universal Cells Inc. in February
2018.
- In November 2017, exercised an
exclusive option right to acquire Mitobridge, Inc. and in January
2018, Mitobridge, Inc. became a wholly-owned subsidiary of
Astellas.
- In February 2018, entered into a global
exclusive licensing agreement on development / commercialization of
an immunostimulating gene loading oncolytic virus with Tottori
University.
The following are the main development advances achieved during
FY2017.
- In January 2018, filed applications in
Europe and the U.S. for approval of an additional indication for
non-metastatic castration-resistant prostate cancer based on the
results of the Phase 3 PROSPER trial obtained in September 2017.
Furthermore, in February 2018, an approval of XTANDI® Tablets
(additional dosage form) was received in Japan for
castration-resistant prostate cancer.
- FLT3/AXL inhibitor gilteritinib
(ASP2215) was granted Orphan Drug designation in the U.S. in July
2017, in Europe in January 2018, and in Japan in March 2018.
Furthermore, gilteritinib received Fast Track Designation in the
U.S. in October 2017 for the treatment of adult patients with FLT3
mutation-positive (FLT3mut+) relapsed or refractory acute myeloid
leukemia.
- In May 2017, MSD K.K. filed an
application for approval in Japan with regard to the indication of
type 2 diabetes for SUJANU® Combination Tablets, a combination drug
of JANUVIA® Tablets and Suglat® Tablets. In March 2018, MSD K.K.
obtained the approval.
- In June 2017, filed an application for
approval in the U.S. for the use of mirabegron in combination with
solifenacin 5 mg.
- In July 2017, filed an application for
marketing approval in Japan with regard to fidaxomicin for the
treatment of infectious enteritis.
- In August 2017, Amgen Astellas
BioPharma K.K. obtained approval in Japan for the Repatha® SC
Injection 420 mg Auto Mini Doser (additional dosage
formulation).
- In September 2017, filed an application
for approval for Linzess® in Japan, as an additional indication for
chronic constipation.
- In November 2017, submitted a new drug
application in Japan for a 12-week extended-release formulation of
Gonax® for the treatment of prostate cancer (additional dosage
formulation).
- In January 2018, Amgen Astellas
BioPharma K.K. submitted an application in Japan for the bispecific
CD19-directed CD3 T cell engager antibody construct blinatumomab
(AMG103) to treat relapsed or refractory B-cell precursor acute
lymphoblastic leukemia.
- In January 2018, submitted an
application for the additional indication of Suglat® for the
treatment of type 1 diabetes mellitus in Japan.
- In February 2018, obtained approval in
Europe for solifenacin (YM905) oral suspension for the treatment of
neurogenic detrusor overactivity in pediatric patients aged 2 to 18
years.
- In March 2018, enfortumab vedotin, an
Antibody-Drug Conjugate (ADC), was granted Breakthrough Therapy
Designation in the U.S.
Pursuing Operational Excellence
The following are the main operational excellence initiatives
engaged during FY2017.
- In April 2017, the asset purchase
agreement to allow the transfer of 16 long-listed products in Japan
to LTL Pharma Co., Ltd. came into effect. In FY2017, the affected
products were transferred to LTL Pharma Co., Ltd.
- In April 2017, we established a new
global function that will manage the respective regional legal
functions and intellectual property functions of Japan, the
Americas, EMEA, and Asia and Oceania.
- In October 2017, transferred to Maruho
Co., Ltd. the manufacturing and marketing approvals in Japan for
Protopic®, a treatment for atopic dermatitis.
- Terminated research operations of
Agensys, Inc. by March 2018.
Enhancing and strengthening the corporate governance
system
Resolved at the meeting of the Board of Directors held in
January 2018 to transition to a company with an Audit &
Supervisory Committee. This results in further enhancing
deliberation on matters such as business strategy in the Board of
Directors and further strengthening the supervisory functions of
the Board of Directors.
The transition is subject to approval at the Company’s 13th Term
Annual Shareholders Meeting to be held in June 2018.
1 EMEA: Europe, the Middle East and Africa
2 Sales by Region: Based on location of sellers
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company
dedicated to improving the health of people around the world
through the provision of innovative and reliable pharmaceutical
products. We focus on Urology, Oncology, Immunology, Nephrology and
Neuroscience as prioritized therapeutic areas while advancing new
therapeutic areas and discovery research leveraging new
technologies/modalities. We are also creating new value by
combining internal capabilities and external expertise in the
medical/healthcare business. Astellas is on the forefront of
healthcare change to turn innovative science into value for
patients. For more information, please visit our website at
https://www.astellas.com/en.
Cautionary Notes
In this press release, statements made with respect to current
plans, estimates, strategies and beliefs and other statements that
are not historical facts are forward-looking statements about the
future performance of Astellas. These statements are based on
management’s current assumptions and beliefs in light of the
information currently available to it and involve known and unknown
risks and uncertainties. A number of factors could cause actual
results to differ materially from those discussed in the
forward-looking statements. Such factors include, but are not
limited to: (i) changes in general economic conditions and in laws
and regulations, relating to pharmaceutical markets, (ii) currency
exchange rate fluctuations, (iii) delays in new product launches,
(iv) the inability of Astellas to market existing and new products
effectively, (v) the inability of Astellas to continue to
effectively research and develop products accepted by customers in
highly competitive markets, and (vi) infringements of Astellas’
intellectual property rights by third parties.
Information about pharmaceutical products (including products
currently in development) which is included in this press release
is not intended to constitute an advertisement or medical
advice.
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Contacts for inquiries or additional information:Astellas
Pharma Inc.Corporate CommunicationsTEL: +81-3-3244-3201FAX:
+81-3-5201-7473orUS Media:Astellas US LLCTarsis Lopez,
224-205-8833tarsis.lopez@astellas.com