Daiichi Sankyo Reports FY2022 Enhertu Revenue of $1.556 Billion Amid Rapid Growth and Expanded Indications

On April 27, Daiichi Sankyo announced its financial report for the fiscal year 2022, with total revenue of 1,278.5 billion yen (at the exchange rate of 1 yen = 0.0075 USD on April 27, 2023, approximately 9.589 billion USD), representing a year-on-year increase of 22.4%; revenue in China was 58.3 billion yen (approximately 437 million USD), representing a year-on-year increase of 9.3%; R&D expenses were 336.7 billion yen (approximately 2.525 billion USD), representing a year-on-year increase of 32.5%.

Enhertu, the star product in the oncology field, generated annual revenue of 207.5 billion yen (approximately 1.56 billion U.S. dollars, including AstraZeneca's share), representing a year-on-year increase of 217.5%. Of this, Daiichi Sankyo's share of sales was 181.6 billion yen (approximately 1.36 billion U.S. dollars), marking a year-on-year growth of 127.2%. The remarkable growth in Enhertu’s sales is mainly due to the approval of its indication for HER2-low breast cancer, which is expected to receive approval in China by October 2023.

Daiichi Sankyo and AstraZeneca are still working to expand the oncology indications for Enhertu, with three pivotal clinical trial results for the product expected to be announced in 2023:

• DESTINY-Breast06 Study (Phase III): First-line Treatment for HR+ and HER2 Low-expression Breast Cancer.

• DESTINY-CRC02 Study (Phase II): Third-Line Treatment for HER2+ Advanced or Metastatic Colorectal Cancer.

• DPT02 Study (Phase II): Second-line Treatment for HER-2+ Advanced Biliary Tract Cancer, Bladder/Urothelial Cancer, and Platinum-refractory or Platinum-resistant Advanced Ovarian Cancer.

In addition to Enhertu, there are two other重磅ADC drugs in Daiichi Sankyo's pipeline: Dato-DXd and HER3-DXd, both of which have entered Phase III clinical trials. In 2023, Daiichi Sankyo will also announce the results of the Phase III clinical trial (TROPION-Lung01) for Dato-DXd as a second/third-line treatment for NSCLC and the results of the Phase III clinical trial (TROPION-Breast01) for second/third-line treatment of HR+ and HER2 low-expression/HER2-negative breast cancer.

In the fiscal year 2022, Daiichi Sankyo's oncology business revenue reached 185.4 billion yen (approximately 1.391 billion US dollars). Daiichi Sankyo expects that by 2025, its oncology business revenue will grow to 900 billion yen (approximately 6.75 billion US dollars), driven by three key ADC products.

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