[April 27, 2017] |
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Astellas Reports Full Year FY2016 Financial Results
Astellas Pharma Inc. (TOKYO:4503)(President and CEO: Yoshihiko Hatanaka,
"Astellas") today announced the financial results for fiscal year 2016
("FY2016") ended March 31, 2017.
"We achieved multiple milestones including the acquisition of
Ganymed last December and an agreement with Ogeda shareholders to
acquire Ogeda last month. These acquisitions and other alliances will
expand Astellas' late-stage pipeline and contribute to its mid-to-long
term growth," said Yoshihiko Hatanaka, President and CEO, Astellas. "We
remain committed to creating innovative medical solutions and delivering
value for patients and all stakeholders, as we continue to advance our
strategic plan through maximizing the product value, creating innovation
and pursuing operational excellence in the fiscal year 2017."
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Consolidated Financial Results (April 1, 2016 - March 31, 2017)
(core basis) (Millions of yen)
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FY2015
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FY2016
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Change (%)
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Sales
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1,372,706
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1,311,665
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-61,041
(-4.4%)
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Core operating profit
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267,456
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274,554
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+7,098
(+2.7%)
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Core profit for the year
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198,802
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213,343
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+14,541
(+7.3%)
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Basic core earnings per share (yen)
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92.12
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101.15
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+9.03
(+9.8%)
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Full-Year Financial Results
Sales for the full-year of FY2016 decreased by 4.4% compared to the
previous fiscal year ("year-on-year") and resulted in 1,311.7 billion
yen. Sales decreased due to the impact of foreign exchange as well as
the impact of the NHI drug price revision in Japan enforced in April
2016. Sales increased by approximately 2% year-on-year excluding the
factors associated with the transfer of the global dermatology business
implemented in April 2016 and the impact of the foreign exchange.
In terms of global products, sales of XTANDI® marginally
increased and sales of overall OAB treatments Vesicare®
(solifenacin succinate) and Betanis® / Myrbetriq®
/ BETMIGA® (mirabegron) decreased due to the impact of
foreign exchange, but sales of each product steadily increased on a
local currency basis. Prograf® (tacrolimus) sales also
decreased.
[ Sales by Region1 ]
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Sales in Japan decreased by 3.3% year-on-year to 480.8 billion
yen. Sales in the Japanese market decreased by 6.3% year-on-year to
452.7 billion yen mainly due to the impact of the NHI drug price
revision. Sales growth continued for products such as overall OAB
treatments (Vesicare® and Betanis®), Celecox®
(celecoxib), Symbicort® (budesonide and formoterol fumarate
dihydrate) and Suglat® (ipragliflozin). Sales of XTANDI®
decreased due to the impact of the NHI drug price revision. Sales of
vaccines declined due to the continued impact of shipping restraints
by the manufacturer in FY2015 (shipments of some of the products have
already recommenced). Revenues were impacted by the decline in sales
of products including Lipitor® (atorvastatin calcium) and
Gaster® (famotidine) mainly due to the impact of generics.
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Sales in the Americas decreased by 9.4% year-on-year to 412.4
billion yen; however sales on a U.S. dollar basis increased by 0.5%
year-on-year to 3,805 million USD. The increase in sales of CRESEMBA®
(isavuconazonium sulfate) contributed to the sales growth. Sales of
products including XTANDI®, overall OAB treatments (VESIcare®
and Myrbetriq®) and Lexiscan® (regadenoson)
decreased due to the impact of foreign exchange, while the sales of
each product on a US dollar basis increased.
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EMEA saw a 0.5% increase in sales year-on-year to 330.8 billion
yen, with growth driven by XTANDI®. Sales on a euro basis
increased by 12.1% year-on-year to 2,785 million euros. Sales of
overall OAB treatments (Vesicare® and BETMIGA®)
and Prograf® declined due to the impact of foreign exchange.
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In Asia and Oceania, sales decreased by 3.8% year-on-year to
87.7 billion yen, while the sales on a constant currency basis
increased by approximately 9%. XTANDI® and overall OAB
treatments (Vesicare® and BETMIGA®) contributed
to the revenue growth. Sales of Prograf® and Harnal®
(tamsulosin hydrochloride) declined mainly due to the foreign exchange
impact.
Other Financial Highlights
Based on the transfer of the global dermatology business in April 2016,
the sales and expenses of the transferred products were not included in
FY2016; however the consideration for the business transfer was
recognized as revenue over certain periods. As a result, there were
certain positive impacts on sales and profit in FY2016.
Strategic Highlights in FY2016
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 multiple accomplishments throughout
FY2016 including the following highlights outlined below.
Maximizing the Product Value
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Continued to maximize the growth of the oncology franchise centered on
XTANDI® and the OAB franchise comprised of Vesicare®
and Betanis® / Myrbetriq® / BETMIGA®
with new launches across various countries and growth in sales
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With respect to the update of the product label for XTANDI®,
including the data from the head-to-head TERRAIN trial of enzalutamide
versus bicalutamide, the Company obtained regulatory approvals in
Europe and the U.S., and the product label was updated in April 2016
in Europe, and October 2016 in the U.S.
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Launched multiple products including Repatha® (evolocumab),
PCSK9-inhibitor for the treatment of hypercholesterolemia in April
2016; Micatrio® Combination Tablets (telmisartan /
amlodipine besylate / hydrochlorothiazide) for the treatment of
hypertension in November 2016; Kiklin® Granules (bixalomer)
for the treatment of hyperphosphatemia in December 2016; and guanylate
cyclase-C receptor agonist, LINZESS (linaclotide), for the treatment
of the irritable bowel syndrome with constipation in March 2017 were
all launched in Japan.
Creating Innovation
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Completion of the acquisition of Ganymed.
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Definitive agreement under which Astellas has agreed to acquire Ogeda.
The
procedures required for this acquisition are still in progress (as of
April 2017).
The following list highlights alliances with external partners announced
during FY2016:
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Entered into a collaborative research agreement with the National
Institute of Advanced Industrial Science and Technology to discover
anti-protozoan parasite drugs for the treatment of Chagas' disease in
April 2016.
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Announced the conclusion of a joint research agreement with Daiichi
Sankyo Company, Limited and Takeda Pharmaceutical Company Limited to
comprehensively acquire and analyze fundamental biomarker data in May
2016.
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Entered into a collaborative development agreement with the Institute
of Medical Science, the University of Tokyo, to develop a rice-based
oral vaccine in June 2016.
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Expanded its collaboration agreement in skeletal muscle activators
with Cytokinetics, Inc. (U.S.) ("Cytokinetics") to include amyotrophic
lateral sclerosis ("ALS") in July 2016. Through this amendment, the
development of fast skeletal troponin activator, CK-2127107 for the
potential treatment of ALS, will be conducted.
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Established DigiTx Partners LLC (U.S.), a digital health investment
company in partnership with MPM Capital, Inc. (U.S.) in July 2016.
DigiTx Partners LLC will invest in the digital health space broadly.
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Signed a memorandum of understanding to create a method for analyzing
circulating tumor cells, with Sysmex Corporation and Daiichi Sankyo
Company Limited in December 2016.
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Executed a license agreement with respect to an exclusive worldwide
license for the AU-935 program for the treatment of chronic tympanic
membrane perforation with Auration Biotech, Inc. (U.S.) in January
2017.
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Entered into an exclusive worldwide license agreement to develop and
commercialize a vaccine targeting Streptococcus pneumoniae
(pneumococcus) with Affinivax, Inc. in February 2017.
The following lists the main development advances achieved during FY2016:
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Submitted applications for approval of extended-release tablets of
quetiapine fumarate (generic name, development code: FK949E) for the
indication of the improvement of depressive symptoms associated with
bipolar disorder in August 2016 in Japan.
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Obtained approval of Kiklin® Granules in September 2016 in
Japan.
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Submitted applications for the approval of XTANDI® Tablets
in September 2016 in Japan.
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Obtained marketing approval for a guanylate cyclase-C receptor
agonist, LINZESS®, for the indication of irritable bowel
syndrome with constipation in December 2016 in Japan.
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Submitted an application for the approval of romosozumab (generic
name, development code: AMG 785) for the treatment of osteoporosis for
those at high risk of fracture in December 2016 in Japan.
Pursuing Operational Excellence
The following lists the main operational excellence initiatives which
occurred during FY2016:
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Transferred the global dermatology business to LEO Pharma S/A
(headquarters: Denmark) in April 2016.
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Began operations for Malaysia-based subsidiary, Astellas Pharma
Malaysia Sdn. Bhd. in April 2016. In addition, the SESA Umbrella
Organization which is responsible for overseeing operations in the
South East and South Asia regions was established and began operation
in April 2016.
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Transferred the manufacturing subsidiary, Astellas Pharma
Technologies, Inc. (U.S.) to Avara Norman Pharmaceutical Services,
Inc. (U.S.) in August 2016.
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Decided to outsource facility and equipment management support in
Japan, and dissolve Astellas Business Service Company Limited in
November 2016.
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Transferred commercial rights for Qutenza® (capsaicin 8%
patch) to Grünenthal in December 2016.
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Concluded a memorandum of understanding concering the extablishment of
a new structure in Sapporo, Hokkaido with Takeda Pharmaceutical
Company Limited, Teva Takeda Pharma Ltd. and Teva Takeda Yakuhin Ltd.
in February 2017.
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Entered into an agreement providing Kyowa Pharmaceutical Industry Co.,
Ltd. the exclusive right to distribute and promote extended-release
tablets of quetiapine fumarate in Japan in February 2017.
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Entered into an asset purchase agreement with LTL Pharma Co., Ltd.,
under which Astellas will transfer its marketing authorization of 16
long-listed products (the "Products") in Japan, supply business of
active pharmaceutical ingredients / bulk of the Products to third
parties inside and outside of Japan and royalty business of the
Products to LTL Pharma, in March 2017.
2017 Financial Guidance
The forecasts for the fiscal year ending March 31, 2018 ("FY2017") (core
basis) are shown in the table below. The sales forecast is 1,279.0
billion yen (-2.5% year-on-year). While we anticipate continuous sales
growth for XTANDI®, our mainstay product, and also for OAB
treatments due to the growth of Betanis® / Myrbetriq®
/ BETMIGA®, we expect negative impact on sales and profit
from the transfer of the global dermatology business implemented in
April 2016 and the transfer of long-listed products in Japan for which
an agreement was concluded in March 2017. We project a core operating
profit of 254.0 billion yen (-7.5% year-on-year). However, we forecast
core operating profit excluding the factors associated with the
transfers of the dermatology business and long-listed products in Japan
as stated above and the impact of the foreign exchange to be higher
year-on-year.
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Consolidated Full-year Business Forecasts (core basis)
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(Millions of yen)
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FY2016
Full-year results
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FY2017
Full-year forecasts
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Change (%)
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Sales
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1,311,665
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1,279,000
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-32,665
(-2.5%)
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Core Operating profit
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274,554
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254,000
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-20,554
(-7.5%)
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Core Profit for the year
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213,343
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195,000
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-18,343
(-8.6%)
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Basic earnings per share (yen)
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101.15
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94.43
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-6.72
(-6.6%)
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NOTE: For further information on the results, please refer to the
reference documents: Financial Results, Supplementary Documents,
Overview of R&D Pipeline and Presentation Material for Information
Meeting available on the Astellas website.
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 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.
1 Europe, the Middle East and Africa 2 Based
on location of sellers
View source version on businesswire.com: http://www.businesswire.com/news/home/20170426006926/en/
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