AstraZeneca PLC (NASDAQ:AZN) Q2 2023 Earnings Call Transcript

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The combination has also shown benefit in breast cancer with BEGONIA, but we saw a 91% disease control rate with durable responses in first-line triple-negative breast cancer. These results support stronger benefit of the combination of Dato-DXd and immune checkpoint inhibition. Moving now on to breast cancer. Our first Phase III trial is due to read out later this year. TROPION-Breast01 investigates Dato-DXd versus chemotherapy in patients with hormone receptor positive HER2-negative metastatic breast cancer that have received at least one prior line of chemotherapy. Our confidence in this trial is twofold. First, we saw encouraging signals from the HR-positive cohort of TROPION-PanTumor01, with a disease control rate of 85% and a median PFS of 8.3 months in a more heavily pretreated population compared with TB01.

Second, we already have proof-of-concept for TROP02 directive treatment in this space. Phase III data for another compound demonstrating efficacy in a late-line HR-positive population. We also have two Phase IIIs focused on triple-negative breast cancer. TROPION-Breast02 investigates where the Dato-DXd can replace chemotherapy in first-line patients not eligible to PD-1 or PD-L1 inhibition. And TROPION-Breast03 investigates the role of adjuvant Dato-DXd with or without Imfinzi in early triple-negative disease. We are on track to deliver on the promise of Dato-DXd in lung and breast cancer and TROPION-PanTumor01 and 03 are generating the data needed to support further investments in the future. And with that, please advance to the next slide, and I’ll pass over to Ruud to cover biopharmaceuticals performance.

Ruud Dobber: Thank you, Susan. Next slide, please. Biopharmaceuticals delivered total revenue of $9.1 billion in the first half with both CVRM and R&I posting double-digit growth. Within global CVRM, Farxiga total revenue grew 41% to $1.5 billion in the quarter, driven by continued uptake in CKD and heart failure. Farxiga is now approved in 62 countries for patients with heart failure with preserved ejection fraction. And this quarter, we were pleased to gain approval in the United States for deliver, which means heart failure patients can now benefit from Farxiga regardless of the left ventricular ejection fraction status. Fasenra, Breztri, Tezspire and Saphnelo, continued their strong momentum, delivering combined growth of 48% in the first half.

These brands are becoming a larger driver of our overall performance. In the second quarter, these brands made up 46% of our R&I total revenue, up from 36% in the first quarter. Next year, we will add another innovative medicine to our portfolio with the launch of Supra in 2024. In the second quarter, Fasenra grew 16% to $406 million, driven by strong demand in the US and Europe as well as some favorable inventory movements in the quarter. We recently filed Fasenra for its first approval in China following positive high-level results from the miracle trial. Tezspire delivered $81 million in total revenue in the second quarter, up from just $13 million last year. When we look at the combined global sales by AstraZeneca and our partner Amgen, Tezspire reached $257 million in the half, an impressive achievement in only one year since launch.

Tezspire is now available in the 11 markets and has enjoyed notable early success in the US, Japan and Germany, with more European launches to come later this year. [indiscernible] total revenue in the second quarter remained stable. However, we still anticipate the entry of generic competition in the United States in the back half of the year. In V&I, we saw the first product sales for Beyfortus, which is now approved in the United States following a unanimous vote by the FDA Antimicrobial Drugs Advisory Committee supporting Beyfortus benefit risk profile. AstraZeneca manufactured Beyfortus and then supplies product to Sanofi for distribution, and we record our sales through Sanofi as product sales. We also booked alliance revenue earned on Sanofi’s Beyfortus sales outside the US where we shared profits with Sanofi.

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