Message from the President
Update: November 2, 2026
I would like to express my sincere appreciation for your continued support and confidence.
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 committed to researching and developing innovative and valuable therapeutic options on a global basis, with a particular focus on Japan and the U.S.
In March 2026, based on the achievements of the structural reforms and business transformation initiatives implemented under “Reboot 2027,” we launched a new growth strategy through FY2028, “Boost 2028 - Accelerating Strong Sumitomo Pharma.” To support the execution of this growth strategy, we conducted a public offering of shares in April 2026 to strengthen our financial foundation and secure funding for growth investments. As a result, we secured the funds necessary for R&D and strategic investments while also strengthening our financial foundation through debt repayment.
I would now like to provide an overview of the Sumitomo Pharma Group’s business performance for the first six months of FY2026, from April 1 to September 30, 2026.
In our U.S. business, we are working to expand sales and maximize the value of ORGOVYX® for advanced prostate cancer and GEMTESA® for overactive bladder. Sales of both products continued to grow, and GEMTESA® significantly exceeded our sales plan for the period.
In our Japan business, in addition to maximizing the value of our core products in the CNS and metabolic areas, we are working to strengthen our earnings base by leveraging sales alliances. We are promoting market penetration and sales growth for each product, including alliance products such as ZEPRION®, Ozempic®, and Wegovy®.
As a result, revenue amounted to 266.5 billion yen, an increase of 17.3% year-on-year. On the other hand, core operating profit decreased 56.2% year-on-year to 42.1 billion yen, and profit attributable to owners of the parent decreased 61.3% year-on-year to 38.2 billion yen. These decreases reflected the sale of our China and Asia business in the previous fiscal year, as well as increased SG&A expenses and R&D expenses to support further growth.
In light of strong business performance and a revision to our assumed foreign exchange rates, we have revised our consolidated financial forecasts upward for FY2026. We now forecast revenue of 565.0 billion yen, an increase of 25.0 billion yen from our initial forecast and 24.6% year-on-year; core operating profit of 105.0 billion yen, an increase of 14.0 billion yen from our initial forecast and a decrease of 0.9% year-on-year; and profit attributable to owners of the parent of 94.0 billion yen, an increase of 17.0 billion yen from our initial forecast and a decrease of 12.0% year-on-year. Despite the absence of the 49.0 billion yen gain from the sale of the Asia business that was recorded in the previous fiscal year, we expect core operating profit to be broadly in line with the record level achieved in the previous fiscal year, driven by continued sales growth of our core products and the expected receipt of a sales milestone payment for ORGOVYX® in the second half of FY2026.
Within our development pipeline, we have designated two oncology assets as our highest-priority programs and are advancing their development with the aim of bringing them to market as quickly as possible. Enzomenib (DSP-5336), which is being developed for acute leukemia, is currently being evaluated in a Phase 2 pivotal study as monotherapy with a view to a regulatory submission and in a Phase 1/2 study of combination therapy. In October 2026, enzomenib received Breakthrough Therapy designation*1 from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory acute leukemia with KMT2A rearrangements. We will further accelerate the development of enzomenib, which we aim to develop into a best-in-class therapy, so that we can deliver it to patients as a new treatment option as quickly as possible. Nuvisertib (TP-3654), which is being developed for myelofibrosis, is being evaluated in Phase 1/2 studies both as monotherapy and in combination with momelotinib. New clinical data on the combination therapy were presented at the 2026 European Hematology Association (EHA) Congress, and we will continue to advance its development with the aim of maximizing its value.
We are also focusing on the regenerative medicine/cell therapy business as one of the pillars that will drive the future growth of the Sumitomo Pharma Group. In March 2026, based on data from an investigator-initiated clinical study conducted by Kyoto University, AMCHEPRY®, an allogeneic iPS cell-derived dopaminergic neural progenitor cell product, received conditional and time-limited marketing approval in Japan for the improvement of motor symptoms in patients with Parkinson’s disease who have had an inadequate response to existing drug therapies. AMCHEPRY® became the world’s first approved medicine derived from iPS cells.
In October, the first patient underwent transplantation in the post-marketing clinical study (Phase 4 study) being conducted to obtain full approval. We will steadily advance this study while also pursuing clinical development in the U.S., with the aim of bringing AMCHEPRY® to more patients with Parkinson’s disease and maximizing its business value globally.
Furthermore, in the infectious disease area, we are pursuing initiatives that leverage our proprietary vaccine and adjuvant technologies with a view to creating new growth opportunities for the future. As part of these efforts, we are advancing the development of the universal influenza vaccine fH1/DSP-0546LP. Results from a Phase 1 study in Europe, announced in September 2026, demonstrated favorable safety and tolerability through one year after administration, with the increase in anti-LAH*2 antibody titers maintained through one year after administration.
Due to the deterioration in our business performance, we had been unable to pay dividends for three fiscal years. Given the uncertainties regarding the receipt of a sales milestone payment and the outlook for the external environment, we had announced that our dividend forecast for the fiscal year ending March 31, 2027 was undetermined and would be decided based on future business performance and other factors, although our business performance had improved in the previous fiscal year. Having considered factors such as our business performance for the first half of the fiscal year and future business prospects, we have decided to resume dividend payments with the year-end dividend for the fiscal year ending March 31, 2027, and now forecast a year-end dividend of 15 yen per share. No interim dividend will be paid.
We will continue to value proactive dialogue with our diverse stakeholders. By strengthening our corporate governance framework and ensuring compliance across our operations, we will work to continuously enhance corporate value and contribute to the realization of a sustainable society.
We sincerely appreciate your continued understanding and support.
Representative Director,
President and CEO
Sumitomo Pharma Co., Ltd.
November 2026
- *1Breakthrough Therapy designation:
- A U.S. program designed to expedite the development and review of drugs intended to treat serious or life-threatening conditions. The designation provides opportunities for enhanced interaction and guidance from the FDA throughout the development program. To qualify for the designation, clinical trial evidence, including unpublished data, must indicate that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.
- *2LAH (Long Alpha Helix):
- A conserved, normally hidden antigenic region common across a broad range of influenza viruses. The formulation contains a modified hemagglutinin antigen engineered to expose the LAH region.