On November 12, AstraZeneca announced three major developments:
On November 12, AstraZeneca released its Q3 2024 financial report. The company's revenue for the first three quarters of 2024 was $39.182 billion, a 19% year-on-year increase (at constant exchange rates), and core earnings per share (EPS) was $6.12, up 11%. For Q3, the revenue was $13.565 billion, a 21% year-on-year increase, and core EPS was $2.08, up 27%.
Based on these results, AstraZeneca has raised its full-year performance growth expectations. The company now anticipates a high single-digit to low double-digit growth in total revenue and core EPS for 2024, up from the previous expectation of mid-single-digit growth.
Geographically, revenue from the U.S. market was $16.703 billion (+20%), emerging markets revenue was $10.541 billion (+23%), and China’s revenue was $5.049 billion (+15%), accounting for approximately 12.89% of AstraZeneca's total revenue for the first three quarters.
AstraZeneca announced it will invest $3.5 billion in the U.S., focusing on expanding the company's research and manufacturing capabilities by the end of 2026. This includes a $2 billion new investment, which will create over 1,000 new high-skilled jobs and contribute to U.S. economic growth. These investments are the first step in a series of strategic actions aimed at helping AstraZeneca reach its ambitious goal of $80 billion in total revenue by 2030, as announced in May. A key element of this strategy is accelerating the company's expansion in the U.S., which is AstraZeneca's largest market, accounting for 44% of its total revenue.
AstraZeneca’s growing business in the U.S. includes: an advanced R&D center in Kendall Square, Cambridge, Massachusetts; next-generation biologics manufacturing facilities in Maryland; cell therapy manufacturing capabilities on the East and West Coasts; and specialized manufacturing in Texas. The company currently employs approximately 17,800 people across 17 R&D, manufacturing, and commercial sites in 12 states.
AstraZeneca and Daiichi Sankyo announced that, based on feedback from the U.S. FDA, the two companies have submitted a Biologics License Application (BLA) for their jointly developed Trop2 ADC, datopotamab deruxtecan (Dato-DXd), seeking accelerated approval for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations, who have previously received systemic therapy, including EGFR-targeted therapy. At the same time, the companies voluntarily withdrew the previous BLA submitted to the FDA for the treatment of advanced or metastatic non-squamous NSCLC patients.
The new BLA submission is primarily based on positive results from the TROPION-Lung05 Phase 2 trial and supported by data from the TROPION-Lung01 Phase 3 and TROPION-PanTumor01 Phase 1 trials. The TROPION-Lung05 and TROPION-Lung01 trials evaluated the efficacy and safety of datopotamab deruxtecan in patients with EGFR-mutated NSCLC who have been treated previously. The results of the two trials will be presented at the upcoming European Society for Medical Oncology (ESMO) Asia 2024 conference.
The results from the TROPION-Lung01 Phase 3 trial showed statistically significant improvement in progression-free survival (PFS) for patients with locally advanced or metastatic NSCLC who received datopotamab deruxtecan, compared to the current standard of care, docetaxel. These patients had previously received at least one prior therapy. The safety profile of datopotamab deruxtecan was consistent with results observed in other ongoing trials, with no new safety concerns.
Partial results from the TROPION-Lung05 trial showed an intracranial objective response rate (ORR) of 22% (95% CI: 6–48) and an intracranial disease control rate (DCR) of 72% (95% CI: 47–90) in 18 treated patients with target brain lesions. Of these 18 patients, 10 (56%) showed a reduction in the total sum of the brain tumor diameters.
AstraZeneca and Daiichi Sankyo are also conducting the TROPION-Lung14 and TROPION-Lung15 Phase 3 trials to evaluate the efficacy of datopotamab deruxtecan alone or in combination with Tagrisso (osimertinib) for the treatment of advanced or metastatic EGFR-mutant non-squamous NSCLC. Additionally, ongoing Phase 3 trials for first-line advanced or metastatic non-squamous NSCLC, AVANZAR and TROPION-Lung10, may validate TROP2 as a quantitative cancer-specific (QCS) biomarker identified in the exploratory analysis of TROPION-Lung01. Another trial is planned for second-line non-squamous NSCLC biomarker-positive tumor patients.
