Daiichi Sankyo (TSE: 4568) reported financial results for the second quarter of fiscal year 2026, ending September 30, 2026.
“Strong revenue growth continues in the second quarter of fiscal year 2026, driven by Enhertu and Datroway. These medicines have received nine new approvals across multiple indications since last quarter, including same day breast cancer approvals in Japan and China, which will allow us to bring these medicines to more patients,” said Hiroyuki Okuzawa, President and CEO of Daiichi Sankyo. “We also continue to explore novel combination strategies to deliver greater benefits to more patients through our DXd antibody drug conjugates as demonstrated by our new clinical trial collaboration to evaluate Datroway with ivonescimab.”
Q2 FY2026 Results
Global revenue increased 19.7% year-over-year to 1.167 trillion yen, driven by the company’s global oncology medicines. Operating profit increased 34.4% year-over-year to 193.8 billion yen.
Global revenue was driven by Enhertu® and Datroway®, the company’s two lead antibody drug conjugates (ADCs). Enhertu revenue, including milestone payments, was 500.0 billion yen, a 51.4% increase year-over-year. Datroway revenue, including milestone payments, was 54.4 billion yen, a 161.6% increase year-over-year.
Revenue from the Oncology Business in the U.S., Europe and Canada was 422.6 billion yen, a year-over-year increase of 54.8%, with revenue driven by Enhertu and Datroway. Japan Business was 232.7 billion yen, a year-over-year decrease of 6.9%, with revenue driven by Lixiana®, Tarlige®, Enhertu and Pralia®. ASCA (Asia, South and Central America) Business revenue was 142.5 billion yen, a 20.9% year-over-year increase, driven by Enhertu. European Union (EU) Specialty Business revenue was 149.2 billion yen, a 9.1% year-over-year increase, driven by Lixiana and Nilemdo®/Nustendi®.
Full fiscal year 2026 guidance remains unchanged. Global revenue is anticipated to reach 2.34 trillion yen with an operating profit of 320.0 billion yen.
Further details on financial performance can be found in the Financial Results Presentation Material. Daiichi Sankyo will host an investor and media conference call and webcast to discuss Q2 FY2026 results on Friday, October 30 at 5:30 pm Japan Standard Time.
Q2 FY2026 and Recent Portfolio / Pipeline Highlights
Daiichi Sankyo continued to advance its portfolio and pipeline with several milestones across its oncology portfolio, demonstrating momentum towards its goal of launching 20 new indications across five medicines by 2030.
Eight additional breast cancer approvals for Enhertu and Datroway were received in China, the EU and Japan since Q1 FY2026. These approvals included Enhertu in combination with pertuzumab for the first-line treatment of patients with HER2 positive metastatic breast cancer based on DESTINY-Breast09 and Datroway for the first-line treatment of patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy based on TROPION-Breast02. Additional approvals of Enhertu in the adjuvant setting of HER2 positive early breast cancer based on DESTINY-Breast05 were received in China and the EU.
Enhertu also was approved for a tumor agnostic indication in China based on four phase 2 trials, including DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and DESTINY-PanTumor03.
Data from DESTINY-Lung04 were presented during Presidential Symposium 2 at the IASLC 2026 World Conference on Lung Cancer, which showed Enhertu demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as a first-line treatment of patients with unresectable, locally advanced or metastatic HER2 mutant non-squamous non-small cell lung cancer (NSCLC). The results will be shared with global regulatory authorities for a potential new indication for Enhertu in this lung cancer setting.
The Biologics License Application seeking accelerated approval in the U.S. for ifinatamab deruxtecan (I-DXd) for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) was voluntarily withdrawn. Patient enrollment is near completion in the IDeate-Lung02 phase 3 trial, where these results may support the potential global submissions of ifinatamab deruxtecan for relapsed ES-SCLC.
Daiichi Sankyo and AstraZeneca entered into a clinical trial collaboration agreement with Summit Therapeutics Inc. to evaluate Datroway in combination with ivonescimab across multiple tumor types including lung and breast cancers. The companies intend to begin the collaboration with a phase 3 trial in first-line TNBC. Separately, the TROPION-Urothelial04 phase 3 trial evaluating Datroway as an adjuvant combination treatment in patients with muscle invasive urothelial cancer was initiated.
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Medicine |
Indication |
Q2 FY2026 and Recent Portfolio Updates |
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Enhertu |
Breast |
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Lung |
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Tumor Agnostic |
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Datroway |
Breast and Lung |
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Breast |
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Datroway |
Urothelial |
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I-DXd |
Lung |
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Corporate Highlights
Daiichi Sankyo appointed Ken Keller to the newly created role of Chief Commercialization Officer effective April 1, 2027, where he will be responsible for accelerating further growth of the company’s oncology and specialty medicine business through a new globally integrated Commercialization Unit.
Daiichi Sankyo received a favorable judgment from the Tokyo District Court dismissing all damage claims filed by Northern TK Venture (NTK).
About Daiichi Sankyo
Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to being a trusted healthcare innovator, contributing to the enrichment of quality of life around the world through its strengths in science and technology. At Daiichi Sankyo, we believe progress depends on asking more of science, challenging assumptions and pursuing better answers. Progress like this is built by people who never stop learning, questioning and pushing what’s possible. Together, we work to bring new breakthrough medicines within reach for patients and help shape what comes next in oncology and beyond. For more information, please visit www.daiichisankyo.com and connect with us on LinkedIn.
Forward-Looking Statements
Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo’s future prospects. These forward-looking statements, including words such as “advance,” “anticipate,” “favorable,” “goal,” “momentum,” and “progress” were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are various inherent risks as well as uncertainties involved. As such, please note that actual results of Daiichi Sankyo may diverge materially from the outlook of Daiichi Sankyo or the content of this material. Furthermore, there is no assurance that any forward-looking statements in this material will be realized. Regardless of the actual results or facts, Daiichi Sankyo is not obliged and does not have in its policy the duty to update the content of this material from the date of this material onward.
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