On July 31, Daiichi Sankyo announced its results for the first quarter (April-June) of fiscal year 2023, with total revenues of 350.8 billion yen (approximately $2.7 billion at the 2023 exchange rate of $1=130 yen), an increase of 25.2% year-on-year.
Enhertu, the star product in oncology, generated total revenues of ¥86.6 billion ($666 million) in April-June, up 49.2% year-on-year, comprising ¥81.7 billion ($628 million) in global sales and ¥4.9 billion ($38 million) in upfront and milestone payments. Daiichi Sankyo and AstraZeneca are jointly responsible for the development and commercialization of Enhertu in markets other than Japan (where Daiichi Sankyo has exclusive rights).
In April-June, Enhertu reported sales of $375 million in the U.S. and $130 million in Europe, and is expected to reach $1.5 billion in the U.S. for the full year and $583 million in Europe for the full year as population penetration occurs across a number of approved indications.
Enhertu has also seen rapid sales growth in Asia with its approval to be marketed in China for the second-line treatment of HER2-positive advanced breast cancer and HER2 low-expression (IHC 1+ or IHC 2+/ISH-) unresectable or metastatic breast cancer.
In addition to winning multiple indication approvals in breast, non-small cell lung, and gastric cancers, Enhertu also gained positive results in the DESTINY-CRC02 study for the third-line treatment of HER2+ mCRC (metastatic colorectal cancer), and the DESTINY-PanTumor02 study for HER2-expressing solid tumors.
In addition to this, the Phase III TROPION-lung 01 study of the TROP2 ADC Dato-DXd (datopotamab deruxtecan, DS-1062) for the second-line treatment of locally advanced or metastatic NSCLC has also met the primary endpoint of PFS and is in the process of submitting data to the FDA. In addition, Dato-DXd+K drug+chemotherapy triple-agent combination for the first-line treatment of NSCLC also showed encouraging anti-tumor activity.
Separately, Daiichi Sankyo plans to file a marketing application with the FDA in the second half of fiscal year 2023 for HER3 ADC patritumab deruxtecan (HER3-DXd) for the third-line treatment of locally advanced or metastatic NSCLC harboring EGFR mutations.
In this earnings presentation, Daiichi Sankyo disclosed for the first time that it has a new ADC drug, DS-1471, targeting CD147, in Phase I clinical trials. A Phase I study for the treatment of solid tumors is expected to be conducted in H1 of FY2023.