AstraZeneca upgrades full-year guidance amid strong momentum

The FTSE 100 pharmaceutical giant said total revenue for the first nine months increased 19% at constant exchange rates to $39.18bn, driven primarily by a 19% rise in product sales.

Alliance revenue also grew significantly, up 50% at constant currency, while collaboration revenue declined.

Core earnings per share grew 11% to $6.12, bolstered by high single-digit growth in key areas such as oncology and cardiovascular, renal, and metabolism (CVRM) therapies, while operating and tax efficiencies further supported financial performance.

“Our company has continued on its strong growth trajectory in the first nine months of 2024,” said chief executive officer Pascal Soriot.

“Total revenue and core earnings per share were up 21% and 27% respectively in the third quarter, reflecting the increasing demand for our medicines across oncology, biopharmaceuticals and rare disease and supporting an upgrade to our full year 2024 guidance.

“In the year to date we have announced the results for multiple positive high-value trials and are working to bring these new options to patients as quickly as possible.”

On the regulatory front, AstraZeneca, in collaboration with Daiichi Sankyo, said it had submitted a new biologics licence application (BLA) to the US FDA for accelerated approval of datopotamab deruxtecan for advanced EGFR-mutated non-small cell lung cancer (NSCLC) in patients who had previously undergone systemic therapy.

The submission followed feedback from the FDA, and was based on data from the TROPION-Lung05 phase two trial.

Additionally, a previously submitted BLA for a broader nonsquamous NSCLC indication had been voluntarily withdrawn.

“TROPION-Lung01 was designed to test the potential to improve upon standard-of-care chemotherapy in a broad, previously treated, advanced lung cancer patient population,” said AstraZeneca’s executive vice-president of oncology research and development, Susan Galbraith.

“The results, together with data from TROPION-Lung05, showed an especially pronounced benefit for patients with an EGFR mutation which informed our discussions with the FDA and the decision to seek accelerated approval of datopotamab deruxtecan in this patient population.

“TROPION-Lung01 has also provided exciting exploratory data supporting our biomarker development, which will be validated in ongoing and planned Phase III lung cancer trials.”

In other clinical developments, AstraZeneca said ‘Koselugo’, or selumetinib, had shown positive results in the KOMET phase three trial for adults with neurofibromatosis type 1 (NF1), achieving a meaningful reduction in tumour volume versus placebo.

The success marked a potential expansion of Koselugo’s use beyond paediatric populations, offering a new therapeutic option for adults with symptomatic, inoperable tumours associated with NF1, a rare and debilitating genetic disorder.

“These promising results demonstrate that Koselugo, the first and only approved targeted therapy for certain children with NF1 PN, now has the potential to benefit adult patients for whom there are no approved targeted therapies,” said Marc Dunoyer, CEO at AstraZeneca’s Alexion subsidiary.

“As the largest and only global placebo-controlled phase three trial in adults with NF1 PN, KOMET reinforces our leadership in advancing potential treatment options for people living with this debilitating disease.”

Finally, AstraZeneca announced a $3.5bn capital investment to enhance its facilities and capabilities in the United States by 2026.

That would include the establishment of a new research and development centre in Cambridge, Massachusetts, and a biologics manufacturing facility in Maryland, among other developments, expected to create over 1,000 high-skilled jobs.

“Our multibillion dollar investment reflects the attractiveness of the business environment together with the quality of talent and innovation capabilities here in the United States,” Pascal Soriot added.

“By expanding our R&D and manufacturing footprint, we aim to enhance the development of cutting-edge therapies and support the United States leadership in healthcare innovation.”

Reporting by Josh White for Sharecast.com.