After a string of new approvals, Daiichi Sankyo is boosting sales projection for AstraZeneca-partnered star cancer drug Enhertu.
Daiichi now expects Enhertu could reach sales of 195.2 billion Japanese yen ($1.31 billion) in its 2022 fiscal year, which ends in March 2023. The new number marked a big increase from the 128.4 billion yen forecast that Daiichi offered in July.
The company apparently expects a fast sales ramp for Enhertu. The antibody-drug conjugate raked in 48.2 billion yen in the company's second fiscal quarter ending in September and 31.3 billion yen in the first, with two new approvals in August. That leaves 115.7 billion yen to be achieved the second half of its fiscal year.
The recent approvals buoyed Daiichi's optimism, most importantly its industry-first nod for HER2-low breast cancer obtained in August. In a presentation on Monday during its second-quarter earnings call, Daiichi said Enhertu is having “rapid uptake” in the new indication, which covers some patients whose tumors were previously deemed as HER2-negative.
As for the second-line HER2-positive breast cancer launch since May, Enhertu has already secured the most new-patient share, Daiichi said. The drug beat Roche’s rival drug Kadcyla in a clinical trial to earn that spot.
Meanwhile, Daiichi and AZ are busy moving Enhertu into earlier treatment settings. Its HER-low breast cancer approval covers post-chemo use. In HER2-low breast cancer, the phase 3 DESTINY-Breast06 trial is evaluating Enhertu monotherapy for HR-positive patients who haven’t received chemotherapy. With the DESTINY-Breast09 study, AZ and Daiichi hope to move into newly diagnosed metastatic HER2-positive breast cancer. Looking to further pressure Kadcyla, the two companies have DESTINY-Breast05 trial pitting Enhertu against the Roche drug as an adjuvant therapy after surgery in high-risk HER2-positive breast cancer.
Outside breast cancer, Enhertu in August became the first drug specifically approved for HER2-mutant non-small cell lung cancer. Once again, Daiichi and AZ aim to move that drug from previously treated patients into the frontline setting with the ongoing DESTINy-Lung-4 study.
Enhertu is leading the charge of a business pivot to oncology at Daiichi, followed by anti-TROP2 ADC candidate Dato-DXd, which is also partnered with AZ. By fiscal year 2025, the Japanese pharma hopes to have oncology contributing over 600 billion yen to its 1.6 trillion yen of total revenue, according to a five-year plan unveiled in April 2021. By 2030, Daiichi aims to be a global top 10 player in oncology.
For the entire fiscal year 2022, Daiichi expects total revenue of 1.25 trillion yen, which marks a 100 billion yen increase from its previous projection.
If yen’s current weak position continues, Daiichi may need to update its five-year ambition. The U.S. dollar on average grew 24% stronger versus the yen so far this year compared with a year ago, even wider than the average 20% recorded as of June, Daiichi noted.
During its transformation, Daiichi has offloaded several assets outside of oncology. Earlier this year, the company divested U.S. rights to certain cardiovascular and other legacy products, including the Benicar antihypertension brand and the blood thinner Effient, to Cosette Pharmaceuticals. It has also transferred antibacterial therapy Cravit in China to local firm YaoPharma.