Astellas Pharma : Reports First Half FY2017 Financial Results, Revises Fiscal Year Outlook (pdf 432KB)

Press Release

Astellas Reports First Half FY2017 Financial Results, Revises Fiscal Year Outlook

- 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.

Tokyo, October 31, 2017 - Astellas Pharma Inc. (TSE: 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."

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Consolidated Financial Results (April 1, 2017 - September 30, 2017) (core basis)

(Millions of yen)

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.

• Oncology franchise

  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.

• Urology OAB franchise

  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)

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)

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