- Sales (-1.8%) and core operating profit
(-18.1%) 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 foreign exchange rate impact, sales were
-1.9% and core operating profit was -2.7% respectively.
- Sales of key global products such as
XTANDI® (enzalutamide) for the treatment of prostate cancer and
overactive bladder (“OAB”) treatments Betanis® / Myrbetriq® /
BETMIGA® (mirabegron) grew.
- Astellas continues to create solid and
resilient growth.
Astellas Pharma Inc. (TOKYO:4503) (President and CEO: Yoshihiko
Hatanaka, “Astellas”) today announced the financial results for the
first six months of fiscal year 2017, ending March 31, 2018
(“FY2017”).
“Key global products XTANDI and Betanis / Myrbetriq / BETMIGA
(mirabegron) continued to demonstrate steady growth in the first
six months of FY2017, and milestones such as the positive results
from the Phase 3 PROSPER trial of enzalutamide in non-metastatic
castration resistant prostate cancer patients demonstrate that our
development activities are progressing steadily. Furthermore,
continuous resource allocation is being made with the aim of
realizing sustainable growth over the medium- and long-terms,” 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.”
Consolidated Financial Results (April 1,
2017 – September 30, 2017) (core basis)
(Millions of yen)
First six months of FY2016
First six months
of FY2017 Change(%) Sales 651,673
639,754
-11,919(-1.8%)
Core operating profit 166,455
136,353
-30,102(-18.1%)
Core profit for the period 120,569
106,638
-13,932(-11.6%)
Quarterly Revenue Highlights
Sales in the first six months of FY2017 decreased by 1.8%
compared to those in the corresponding period of the previous
fiscal year (“year-on-year”) to ¥639.8 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 by 11.4% year-on-year to ¥140.3
billion. Sales in the United States (“U.S.”) remained largely
unchanged year-on-year, but sales grew steadily in Japan, the
Americas excluding the U.S., EMEA1 and the Asia and Oceania
region.
Sales of Betanis® / Myrbetriq® / BETMIGA® increased by 26.0%
year-on-year to ¥57.6 billion. Sales increased in all regions:
Japan, the Americas, EMEA and the Asia and Oceania region. Sales of
Vesicare®, however, decreased by 16.9% year-on-year to ¥49.7
billion.
- Transplantation franchise
Sales of Prograf® (tacrolomis) increased by 5.4% year-on-year to
¥99.3 billion, and continued to grow in the EMEA and the Asia and
Oceania regions.
- Other new and key products
In the Japanese market, continued growth was achieved for
products such as Celecox® (celecoxib) for the treatment of
inflammation and pain, Symbicort® (budesonide and formoterol
fumarate dihydrate) for the treatment of bronchial asthma, Suglat®
(ipragliflozin) for the treatment of type 2 diabetes, and Cimzia®
(certolizumab pegol) for the treatment of adult patients with
rheumatoid arthritis. Meanwhile, we have been steadily working to
penetrate the market with our launch of Repatha® (evolocumab) for
the treatment of hypercholesterolemia, which occurred in April
2016, and of LINZESS® (linaclotide) for the treatment of irritable
bowel syndrome with constipation, which occurred in March 2017. In
the Americas, sales of azole antifungal CRESEMBA® (isavuconazonium
sulfate) grew.
(Billions of yen)
First six months of FY2016
First six months
of FY2017 Change Oncology franchise 153.9
167.8
+9.1%
XTANDI® 126.0
140.3 +11.4% Urology OAB
franchise 105.5
107.3 +1.7%
Vesicare® 59.8
49.7 -16.9%
Betanis® /
Myrbetriq® / BETMIGA® 45.7
57.6 +26.0%
Transplantation franchise 94.2
99.3
+5.4%
Sales by Region2
Sales in Japan, the Americas and EMEA decreased, while sales in
Asia and Oceania increased. As for the Japanese market, sales
decreased by 12.5% year on year to ¥194.1 billion largely due to
the impact of transferring 16 long-listed products in April 2017,
and the introduction of generics for Micardis® (telmisartan) for
the treatment of hypertension in June 2017. Meanwhile in EMEA,
sales decreased due to the impact of transferring the dermatology
business in April 2016, yet sales showed an increase when
calculated excluding this impact.
FY2017 Guidance
The company has upwardly revised its forecasts for sales, core
operating profit and core profit for the year from the figures
announced in April 2017 (“initial forecast”) based on the financial
results for the first six months of FY2017 and the trend of foreign
exchange rates. Revised expected exchange rates are anticipated to
cause a ¥20.2 billion increase in sales and a ¥3.8 billion increase
in core operating profit compared to if the expected exchange rates
of the initial forecast were applied.
Consolidated Full-year Business
Forecasts (core basis)
(Millions of yen)
FY2016
Full-year results
FY2017
Full-year forecasts
Change(%) Sales 1,311,665
1,297,000
-14,665(-1.1%)
Core Operating profit 274,554
258,000
-16,554(-6.0%)
Core Profit for the year 213,343
201,000
-12,343(-5.8%)
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.
https://www.astellas.com/en/investors/ir-library
Strategic Quarterly Highlights
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 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 growth in
sales.
Creating Innovation
The following lists the main development advances achieved
during the first six months of FY2017:
- Announced the Phase 3 PROSPER trial
evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy
(ADT) versus ADT alone in patients with non-metastatic
castration-resistant prostate cancer met its primary endpoint of
improved metastasis-free survival in September 2017.
- Submitted an application for marketing
approval of fidaxomicin for the treatment of infectious enteritis
caused by Clostridium difficile in Japan in July 2017.
- Repatha® SC Injection 420 mg Auto mini
doser was approved in Japan in August 2017.
- Submitted a supplemental new drug
application for marketing approval of linaclotide (generic name,
brand name: Linzess® Tablets 0.25 mg), for the additional
indication of chronic constipation (other than constipation
associated with organic disorders) in Japan in September 2017
Pursuing Operational Excellence
- Announced that as of October 1, 2017,
Maruho Co., Ltd will succeed the marketing approval in Japan from
Astellas, for anti-atopic dermatitis agent Protopic® Ointment (July
2017).
- Announced the decision to wind down the
research operations of Agensys, Inc.(U.S.) (July 2017).
(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