Daiichi Sankyo has postponed the publication of its annual report by two weeks to allow additional time to finalize financial figures.
The Japanese drugmaker said the delay was primarily due to the need to review its “oncology drug portfolio and development pipeline supply plan in light of rapidly changing business conditions.”
“As a result, additional consideration is required to reasonably estimate the amount of loss reserves recorded in connection with contracts with contract manufacturers,” the company said in an April 24 announcement (PDF).
Daiichi’s stock price on the Tokyo Stock Exchange fell more than 10% following the delay in announcing its financial results.
At the same time, Daiichi announced that it has decided to announce its new five-year business plan on May 11th, rather than separately on May 19th along with the 2025 financial report.
The first annual report comes weeks after President Donald Trump announced 100% tariffs on patented medicines and ingredients. Existing trade agreements impose a 15% tariff on products from the European Union and Japan. The administration is also willing to offer exemptions under “most-favored-nation” drug pricing agreements similar to those already in place with 17 major pharmaceutical companies.
Daiichi currently operates two proprietary manufacturing facilities in the United States, located in Ohio and New York. Daiichi Pharmaceutical is reportedly investing up to 56 billion yen ($351 million) to build additional facilities at its Ohio campus as part of a global manufacturing expansion plan for its core antibody-drug conjugate business.
The Ohio plant is ADC’s fill-finish and packaging operations. Additionally, Daiichi manufactures the monoclonal antibody component of its existing ADCs in the United States, but not the linker portion of the drug, Ken Keller, who heads Daiichi’s U.S. branch and global oncology business, told Fierce in an interview on the sidelines of the JPMorgan Healthcare Conference in January.
“We think it would be better to consider an on-shore approach, but we are still developing plans,” Keller said at the time.
First, we also use CDMO. The company suffered a setback in 2024 when the FDA rejected patritumab deruxtecan (HER3-DXd), a HER3 ADC partnered with Merck & Co., citing issues with its contract manufacturing facility. The pair later withdrew their application, citing a Phase 3 error regarding overall survival rates for EGFR-mutated non-small cell lung cancer.
In addition to these factors, the ongoing war in Iran is also disrupting the pharmaceutical supply chain by increasing energy costs and complicating logistics.
As of Daiichi’s October 2025 earnings update, the company expects annual sales to reach 2.1 trillion yen ($13.1 billion), an 11.3% increase compared to the previous fiscal year ending in March 2025.
The company aims to have at least four ADCs on the market by 2030: Enherz and Datroway in partnership with AstraZeneca, and Raldotag-Derxtecan for HER3-DXd and CDH6 in partnership with Merck.
As Enhertz continues to advance its treatment of HER2-positive breast cancer, Datroway faces a pivotal trial, the Phase 3 Avanzer trial in first-line NSCLC, expected to be announced this year.
