Message from the President
On behalf of Sumitomo Pharma, I extend my heartfelt gratitude for your unwavering support and trust.
Guided by our Mission—“To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide”—the Sumitomo Pharma Group is devoted to the research and development of innovative and useful products and healthcare solutions globally, with a particular focus on Japan and the U.S.
In May 2025, we announced our new activity policy through fiscal 2027: “Reboot 2027 -Reboot for a Strong Sumitomo Pharma-.” The term Reboot signifies more than a recovery; it reflects our firm resolve to be reborn as a company to strongly accelerate the Value Creation Cycle. We aim to reboot as a strong company and establish ourselves as a Global Specialized Player (GSP).
I would like to walk you through the Group’s financial highlights for the second quarter of the fiscal year 2025 (from April 1 to September 30, 2025).
In the North American business, we continue to strengthen our
revenue base through robust sales growth of two of our three key
products—ORGOVYX® for advanced prostate cancer and GEMTESA® for
overactive bladder—. In addition to expanding sales, we have also
received a milestone payment related to ORGOVYX®, further
reinforcing our financial foundation. MYFEMBREE®, for uterine
fibroids and endometriosis, transitioned to a sole marketing
structure under Sumitomo Pharma in January 2025. Following the
optimization of our commercial operations, we achieved standalone
profitability for MYFEMBREE®.
Furthermore, SG&A and R&D expenses decreased year-on-year due to
the effects of business structural reforms and our reorganization
of the regenerative medicine and cell therapy business, while
gains from the partial divestiture of our Asian business also
contributed to our financial performance.
These efforts produced strong results: Revenue increased by 46.4
billion yen year-on-year to 227.1 billion yen; core operating
profit improved by 96.1 billion yen year-on-year, restoring
profitability at 96.1 billion yen; and net profit improved by
131.1 billion yen year-on-year, turning positive at 98.9 billion
yen.
Reflecting current trends in business performance, we have revised
the full year consolidated financial forecasts announced in May
2025. Revenue has been revised to 429.0 billion yen, an increase
of 30.2 billion yen year-on-year, driven by continued strong sales
in the North America. Core operating profit has been revised to
97.0 billion yen, up 53.8 billion yen year-on-year. Net profit
attributable to owners of the parent has been revised to 92.0
billion yen, up 68.4 billion yen year-on-year, factoring in a
reduction in tax expenses incurred during the first half of the
fiscal year.
In Japan business, we newly entered into co-promotion partnerships for three products—XEPLION®, Ozempic®, and Wegovy®— in 2025. In response, we reorganized our commercial structure into therapeutic-area-based organizational structures to enable more strategic and agile operations. Through effective allocation of resources and leveraging our strong commercial foundation and relationships, we will focus on building strong product brands and deepening market penetration.
Regarding the R&D pipeline, we have prioritized the early launch
of two oncology candidates. While advancing in-house development,
we are actively exploring strategic partnerships to maximize the
value of these assets and mitigate investment and development
risk.
Enzomenib (DSP-5336) for the treatment of acute leukemia has
completed its phase 1 monotherapy study and has entered a phase 2
confirmatory clinical trial. The compound garnered significant
attention at the American Society of Hematology (ASH) meeting in
2024, where it was recognized as Best-in-Class*1, and in October
2025, we announced positive results from an analysis of clinical
data from Japanese patients at the Japanese Society of Hematology
(JSH).
Nuvisertib (TP-3654), expected to offer a new treatment option for
myelofibrosis, is progressing through phase 1/2 monotherapy and
combination studies. In June 2025, the compound received Fast
Track*2 Designation from the U.S. Food and Drug Administration
(FDA), enabling priority review.
We are also advancing field of regenerative medicine/cell therapy as one of the key pillars driving our group’s future growth. In August 2025, we submitted an application of manufacturing and marketing authorization in Japan for allogeneic iPS cell-derived dopaminergic neural progenitor cells for the treatment of Parkinson’s disease, based on the data from the investigator-initiated study conducted by Kyoto University. We aim to obtain approval in Japan within FY2025 as the world’s first practical application of iPS cell-derived products. In the U.S., clinical studies are also underway, and in June 2025, the first patient had been dosed in an investigator-initiated study conducted by University of California San Diego School of Medicine.
We also value active dialogue with a wide range of stakeholders, including patients and their families, healthcare professionals, shareholders, investors, employees, business partners, and local communities. By strengthening our corporate governance framework and ensuring compliance across our operations, we aim to continue enhancing corporate value and contributing to the realization of a sustainable society.
We sincerely appreciate your continued support and encouragement.
Toru Kimura
Representative Director,
President and CEO
Sumitomo Pharma Co., Ltd.
November 2025
- *1Best-in-class: A new drug that offers clear advantages over existing drugs.
- *2Fast Track: A program designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the goal of getting important new drugs to patients earlier.