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Astellas (Japan)'s first-quarter results reflected new launches, particularly prostate cancer drug Xtandi (enzalutamide) in the United States, and benefited hugely from the weaker yen, with net sales up 13.4% year-on-year (y/y) to JPY243.2 billion (USD2.45 billion). Separately, Astellas has also announced the opening of a sales subsidiary in Singapore, and an anaemia drug being developed with FibroGen (US) has moved into the Phase II stage.
IHS Global Insight perspective
The impact of the weaker yen provided a JPY28.3-billion (USD287.6 million) boost to net sales revenues, but also contributed to operating profits falling 27.1% year-on-year (y/y) to JPY52.8 billion, while net income fell by 37.7% y/y to JPY35.4 billion, reflecting costs in restructuring of Astellas' R&D network.
A number of new launches contributed to sales growth, particularly prostate cancer treatment Xtandi (enzalutamide) and overactive bladder drug Myrbetriq (mirabegron) in the United States, with growth in the Americas up 20.5% excluding the impact of the weak yen. Astellas separately announced the opening of a new sales unit in Singapore, and the initiation with US firm FibroGen of an anaemia candidate.
Astellas' R&D restructuring has seen a flurry of deals on external collaborations, most prominently in the creation of a joint venture in Japan with Amgen (US), while other smaller scale deals have been signed with Drais, Cytokinetcs, and Ambrx (all US).
Japan-based pharma firm Astellas has released results for the first quarter (Q1) of the fiscal year (FY) 2013 (ended 30 June 2013). Net sales were up an impressive 13.4% year-on-year (y/y) to JPY275.8 billion (USD2.45 billion), with a JPY32.6-billion increase due to growth in sales and JPY28.3-billion increase due to the weakening Japanese yen. Increased research and development (R&D) and sales, goods and administrative (SG&A) costs due to the yen's weakness contributed to operating profits falling 27.1% y/y to JPY38.5 billion, while costs associated with restructuring the firm's R&D activities played a role in the 37.7% y/y fall in net income to JPY22.1 billion.
In terms of region split, Japan saw a 5.4% y/y drop in sales due to generic competition and other factors, but there was steady growth in all other regions. Europe saw growth of 27.4% y/y, but this was mainly attributed to the weak yen, with growth at 1.4% in local currency terms. In the Americas, growth was 48.4% y/y, but 20.5% in local currency terms, while in Asia growth was 40.5%, or 12.1% excluding the foreign-exchange impact. For a link to Astellas' quarterly results releases, see here.
Astellas: financial highlights, Q1 FY 2013
Q1 FY 12 (JPY bil.)
Q1 FY 13 (JPY bil.)
% change y/y
- Asia and Oceania
Cost of sales
Prostate cancer drug Xtandi (enzalutamide) was most prominent of the new launches, contributing to a 100.5% y/y increase in Astellas' oncology portfolio sales. From launch in September 2012, Xtandi quickly achieved sales of USD82 million in the United States, and EUR2 million in Europe, with revenue growth expected to continue following its July UK launch (see Europe: 25 June 2013: Astellas' oral prostate cancer drug Xtandi gains EU approval). Tarceva (erlotinib) in the US and Eligard (euprolide acetate) in Europe also contributed to growing oncology portfolio sales.
Overactive bladder (OAB) treatment Myrbetriq (mirabegron; marketed as Betanis in Japan, Betmiga in Europe), launched in the US in October 2012, complementing sales of existing growth driver Vesicare (solfenacin succinate). Globally, Astellas' two OAB drugs earned revenues of JPY36.4 billion, up 33.3% y/y.
Astellas, sales of global products, Q1 2013
Q1 FY 12 (JPY bil.)
Q1 FY 13 (JPY bil.)
% change, y/y
Vesicare (solfenacin succinate)
Funguard/Mycamine (micafungin sodium)
Eligard (leuprolide acetate)
Singapore sales office opens, anaemia drug enters Phase II with FibroGen
Coinciding with the results release, Astellas announced the opening of a sales affiliate in Singapore, Astellas Pharma Singapore Pte Ltd. The unit will commercialise products in Singapore using the firm's own sales force, and will co-ordinate the activities of a contract sales organisation in Malaysia.
Separately, the initiation of a Phase II trial in Japan for ASP-1517/FG-4592 – being developed in partnership with US firm FibroGen – as a treatment for anaemia related to chronic kidney disease (CKD) in patients undergoing dialysis was announced. FibroGen stands to receive a USD12.5-million milestone payment as a result of the trial. The firms started a Phase III trial in the indication in December 2012 (see Japan - United States - Europe: 12 December 2012: Astellas, FibroGen begin Phase III trial of CKD-related anaemia drug).
Astellas plans to carry out another Phase II trial of the drug in non-dialysis patients later in 2013. Astellas is responsible for funding development of the candidate in Europe, Japan, the Commonwealth of Independent States, and the Middle East and South Africa, while UK firm AstraZeneca last week snapped up rights in remaining territories including the US (see United Kingdom: 31 July 2013: AstraZeneca collaborates with FibroGen in developing anaemia treatment).
Outlook and implications
Xtandi's performance since launching in the US in September is one of the key highlights for Astellas. The drug has already become the market-leading third-line treatment choice for prostate cancer, taking up 50% of the market, but Kantar Health forecasts the drug may see increasing popularity as a second-choice treatment, in which indication Xtandi currently has a 20% market share behind Zytiga (abiraterone acetate; Johnson & Johnson, US), as reported by Jiho. The drug is on target to achieve sales of USD400 million this year.
Astellas restructured its R&D operations earlier this year, closing down OSI Pharmaceuticals and Perseid Therapeutics units and refocusing on external collaborations (see United States - Japan: 15 May 2013: Astellas to restructure and downsize research operations in US). Shortly after the restructuring was announced, Astellas revealed a partnership with Amgen (US) that will see the firms establishing a joint venture (JV) as a conduit for Amgen to re-establish an independent operation in Japan (see United States - Japan: 29 May 2013: Amgen partners with Astellas on five pipeline drugs, to form Japanese JV). Although Amgen expects to fully take over the JV by 2020, Astellas will continue to co-commercialise the five pipeline medicines included in that deal until 2035 at the latest.
External partnerships now form a central part of Astellas' "multi-track" R&D programme, with recent deals announced with Ambrx, Drais, and Cytokinetics (all US) typical of the new R&D model (see United States - Japan: 8 April 2013: Astellas and Ambrx collaborate on ADC research in oncology; United States - Japan: 8 May 2013: Astellas partners with Drais on third compound and United States - Japan: 26 June 2013: Cytokinetics, Astellas announce USD490-mil. partnership and licence agreement for muscle activation treatments).
In terms of ongoing in-house developments, changes to the R&D pipeline since the full-year results release in May include Xtandi's filing for approval in Japan for prostate cancer, and the combination drug EV-178 solfienacin/mirabegron moving into the Phase III stage in global trials for OAB (see Japan: 13 May 2013: Astellas' 2012/13 sales break JPY1-tril. mark as net profits rise 5.9%).