Introduction
ENHERTU (trastuzumab deruxtecan), a revolutionary antibody-drug conjugate (ADC), has been making significant waves in the oncology market, particularly in the treatment of breast cancer. Developed by Daiichi Sankyo and AstraZeneca, ENHERTU has demonstrated remarkable growth and is poised to continue its dominance in the market.
Approval and Indications
ENHERTU has received several key approvals that have driven its market success. Notably, it was approved for the treatment of HER2-positive metastatic breast cancer (mBC) in the second line in the US, based on the DESTINY-Breast03 study, which showed unparalleled improvement in progression-free survival (PFS) compared to T-DM1[1][3].
In August 2022, ENHERTU received approval for HER2-low breast cancer, previously treated with chemotherapy, marking an industry-first achievement. This approval has significantly expanded its patient base, as HER2-low breast cancer accounts for approximately 50% of breast cancer cases[1][3].
Market Performance
The market performance of ENHERTU has been nothing short of impressive. Since its launch for second-line HER2-positive breast cancer in May 2022, ENHERTU has outperformed competitors, securing the largest share of new patients in the US market. The drug's rapid uptake in the HER2-low breast cancer segment has been particularly noteworthy, achieving the number one new patient share in the US market[1][3].
Sales Growth
ENHERTU's sales have more than doubled from approximately $1.25 billion in 2022 to $2.5 billion in the subsequent year, highlighting its swift adoption and market penetration[4].
In the third quarter of FY2022, global net sales of ENHERTU reached 60.2 billion JPY, with a 25% sequential quarter-over-quarter growth. This growth was driven significantly by the US market, where the drug saw a 89.7% quarter-over-quarter growth in HR+ HER2-low mBC and a 78.9% growth in HR- HER2-low mBC[1].
Revenue Projections
The financial trajectory for ENHERTU looks promising, with the drug expected to continue its growth momentum. The antibody-drug conjugates market, in which ENHERTU is a key player, is projected to reach USD 28.61 billion by 2033. ENHERTU is among the fastest-growing segments in this market[3].
Financial Impact on Daiichi Sankyo and AstraZeneca
The success of ENHERTU has had a significant financial impact on both Daiichi Sankyo and AstraZeneca.
Daiichi Sankyo
For Daiichi Sankyo, ENHERTU has been a major driver of revenue growth. In FY2022, the company's consolidated revenue increased by 22.4% year-on-year to ¥1,278.5 billion, with ENHERTU contributing substantially to this growth. The core operating profit also increased by 35.3% year-on-year to ¥122.6 billion, partly due to the increased sales of ENHERTU[2].
AstraZeneca
AstraZeneca has also seen significant financial benefits from ENHERTU. In Q2 2024, AstraZeneca reported alliance revenue from ENHERTU at $344 million, up from $255 million in Q2 2023. This increase reflects the drug's growing market presence and adoption[5].
Market Expansion and Future Indications
ENHERTU's market expansion is not limited to its current indications. The drug is being explored for additional uses, including the potential to displace chemotherapy rather than being used after chemotherapy in the HER2-low setting. This could further broaden its patient base, potentially making it the biggest drug in breast cancer treatment[4].
Ultra-Low HER2 Setting
Studies have also demonstrated efficacy in the ultra-low HER2 setting, which could help close to 90% of women with breast cancer. This expansive potential underscores ENHERTU's transformative impact on breast cancer treatment[4].
Competitive Landscape
In the ADC market, ENHERTU competes with other notable drugs like Kadcyla. However, ENHERTU's recent approvals and its performance in new indications have positioned it as one of the fastest-growing segments in the market[3].
R&D and Investment
Both Daiichi Sankyo and AstraZeneca are investing heavily in the oncology business, including the development of ENHERTU and other ADCs. This investment is expected to drive further growth and innovation in the field[2][5].
Financial Outlook
For FY2023, Daiichi Sankyo is expecting a 13.4% increase in revenue year-on-year, driven by the continued success of ENHERTU along with other mainstay products. Core operating profit is expected to increase by 14.2% year-on-year, despite increased expenses related to the intensive investment in the oncology business[2].
Cash Flow and Investments
The financial performance of ENHERTU has also positively impacted cash flows from operating activities. In FY2022, net cash inflows from operating activities totaled ¥114.5 billion, partly due to sales-related milestones and regulatory milestones of ENHERTU[2].
Key Takeaways
- Rapid Market Adoption: ENHERTU has seen swift adoption in both HER2-positive and HER2-low breast cancer segments.
- Significant Revenue Growth: Sales have more than doubled from $1.25 billion in 2022 to $2.5 billion in the subsequent year.
- Expansive Indications: The drug is being explored for additional uses, including the ultra-low HER2 setting.
- Financial Impact: ENHERTU has driven substantial revenue and profit growth for both Daiichi Sankyo and AstraZeneca.
- Market Dominance: ENHERTU is poised to continue its dominance in the ADC market, with projections indicating continued growth.
FAQs
What are the current approved indications for ENHERTU?
ENHERTU is approved for the treatment of HER2-positive metastatic breast cancer (mBC) in the second line and for HER2-low breast cancer previously treated with chemotherapy[1][3].
How has ENHERTU performed in terms of sales?
ENHERTU's sales have more than doubled from approximately $1.25 billion in 2022 to $2.5 billion in the subsequent year, driven by its rapid adoption in new indications[4].
What is the market potential of ENHERTU?
ENHERTU has the potential to treat close to 90% of women with breast cancer, including those with HER2-positive, HER2-low, and ultra-low HER2 settings[4].
How has ENHERTU impacted the financial performance of Daiichi Sankyo and AstraZeneca?
ENHERTU has significantly contributed to the revenue and profit growth of both companies, with substantial increases in sales and operating profits reported in recent financial results[2][5].
What are the future prospects for ENHERTU?
ENHERTU is being explored for additional indications, including the potential to displace chemotherapy, and is expected to continue its growth trajectory in the ADC market[4].
Last updated: 2024-12-17
