Company: AZN
Filing Date: 2025-04-04
Form Type: 6-K
Source: 0001654954-25-003894
Chunk: 3

Company: ASTRAZENECA PLC
Filing Date: 2025-04-04
Form: 6-K
Chunk 3
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 recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

#### Financial considerations
Following this approval for Enhertu in the EU, an amount of $125m is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the HER2-low and HER2-ultralow chemotherapy-naïve breast cancer indication. The milestone will be capitalised as an addition to the upfront payment made by AstraZeneca to Daiichi Sankyo in 2019 and subsequent capitalised milestones and will be amortised through the profit and loss statement.

Sales of Enhertu in most EU territories are recognised by Daiichi Sankyo. AstraZeneca reports its share of gross profit margin from Enhertu sales in those territories as alliance revenue in the Company's financial statements. AstraZeneca will record product sales in respect of sales made in territories where AstraZeneca is the selling party.

Further details on the financial arrangements were set out in the March 2019 announcement of the collaboration.

#### Notes

#### Breast cancer and HER2 expression
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 7 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally. 7 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually. 8 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis. 1

HR-positive, HER2-negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers. 1 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast cancer. 9 Patients with high levels of HER2 expression (IHC 3+ or 2+/ISH+) are classified as HER2-positive and treated with HER2-directed therapies, representing approximately 15-20% of all breast cancers. 10 Historically, tumours that were not classified as HER2-positive were classified as HER2-negative. 11

Despite being classified as HER2-negative, many of these tumours may still have some level of HER2 expression detected by IHC. 11 In the DESTINY-Breast06 trial, approximately 85-90