Daiichi Sankyo Reports $666 Million in Enhertu Revenue for Q1 FY2023; Two New ADCs Nearing Regulatory Submissions

On July 31, Daiichi Sankyo announced its financial results for the first quarter (April-June) of the fiscal year 2023, with total revenue reaching 350.08 billion yen (approximately $2.7 billion at the 2023 exchange rate of 1 USD = 130 yen), representing a year-on-year increase of 25.2%.

From April to June, Enhertu, the star product in the oncology field, generated a total revenue of 86.6 billion yen (USD 6.66 billion), representing a year-on-year increase of 49.2%. This includes global sales of 81.7 billion yen (USD 6.28 billion) as well as upfront and milestone payments amounting to 4.9 billion yen (USD 0.38 billion). Daiichi Sankyo and AstraZeneca jointly oversee the development and commercialization of Enhertu in markets outside Japan (Daiichi Sankyo holds exclusive rights in Japan).

From April to June, the sales of Enhertu in the U.S. market reached 375 million USD, and in the European market, it was 130 million USD. With the penetration of several approved indications, it is expected that the total sales in the U.S. market for the whole year will reach 1.5 billion USD, and the total sales in the European market for the whole year will reach 583 million USD.

With Enhertu's approval in China for second-line treatment of HER2-positive advanced breast cancer and HER2-low (IHC 1+ or IHC 2+/ISH-) unresectable or metastatic breast cancer, it has also seen rapid sales growth in the Asian market.

In addition to gaining multiple approvals for indications in breast cancer, non-small cell lung cancer, and gastric cancer, Enhertu also achieved positive results in the DESTINY-CRC02 study for third-line treatment of HER2+mCRC (metastatic colorectal cancer) and the DESTINY-PanTumor02 study for HER2-expressing solid tumors.

In addition, the Phase III TROPION-Lung 01 study of TROP2 ADC Dato-DXd (datopotamab deruxtecan, DS-1062) for second-line treatment of locally advanced or metastatic NSCLC has also met its PFS endpoint, and data is being submitted to the FDA. Furthermore, the triplet regimen of Dato-DXd + Keytruda + chemotherapy for first-line treatment of NSCLC has demonstrated encouraging antitumor activity.

In addition, Daiichi Sankyo plans to submit a BLA to the FDA in the second half of fiscal 2023 for patritumab deruxtecan (HER3-DXd), a HER3 ADC, as a third-line treatment for locally advanced or metastatic NSCLC harboring EGFR mutations.

In this earnings report, Daiichi Sankyo disclosed for the first time that a new ADC drug targeting CD147, DS-1471, has entered Phase I clinical trials. A Phase I study for the treatment of solid tumors is expected to be launched in the first half of the 2023 fiscal year.

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