NEW YORK – AstraZeneca reported on Thursday morning that revenues from its oncology products in the fourth quarter of 2022 increased 12 percent to $4.05 billion at constant exchange rates compared to the same period the prior year.
Overall, the company reported $11.21 billion in revenues in Q4 2022, compared to $12.01 billion in Q4 2021, an increase of 1 percent, and in line with what analysts were expecting on average.
Sales of AstraZeneca's EGFR inhibitor Tagrisso (osimertinib) increased 12 percent to $1.34 billion in Q4 2022, compared to Q2 2021. Over the same period, sales for the PARP inhibitor Lynparza (olaparib) increased 17 percent to $689 million and sales for the immunotherapy Imfinzi (durvalumab) increased 27 percent to $752 million.
During Q4, AstraZeneca recorded $28 million in sales for the HER2-targeted drug Enhertu (trastuzumab deruxtecan), which it markets with Daiichi Sankyo. This was more than three times the sales it recorded for Enhertu in the year-ago period.
During a call to discuss the company's financial performance on Thursday morning, AstraZeneca executives provided an update on the firm's oncology portfolio. Dave Fredrickson, head of AstraZeneca's oncology business, said momentum from the ADAURA study in the adjuvant setting and data from the FLAURA trial demonstrating greater duration of therapy were fueling greater sales of Tagrisso.
The ADAURA trial established Tagrisso as an adjuvant treatment for EGFR-mutated non-small cell lung cancer and FLAURA showed that patients with EGFR-mutated NSCLC who received Tagrisso as first-line therapy had longer overall survival than those who received a comparator EGFR tyrosine kinase inhibitor.
Sales of Enhertu also grew during the quarter, Frederickson noted, and the treatment achieved approximately 50 percent new patient share in the second-line HER2-positive metastatic breast cancer setting and more than 40 percent new patient share in the HR-positive, HER2-low post-chemo setting — an indication approved in the US last year and in Europe in January. "We're excited to expand HER2-low in Europe following the recent approval of [the drug]," based on data from the DESTINY-Breast04 study, Frederickson said.
Lynparza remains the leading PARP inhibitor in first-line homologous recombination repair-deficient ovarian cancer, Frederickson said, and the company is trying to improve testing rates in that indication and in BRCA1/2-mutated breast cancer.
Fourth quarter research highlights included results from the CAPItello-291 trial of capivasertib with fulvestrant in patients with HR-positive, HER2-low or negative locally advanced or metastatic breast cancer, reported at the 2022 San Antonio Breast Cancer Symposium. In that trial, patients who received capivasertib-fulvestrant after progressing on endocrine therapy with or without a CDK4/6 inhibitor, had a clinically meaningful improvement in progression-free survival and a 40 percent reduction in the risk of disease progression or death compared to placebo.
"CAPItello-291 validates the use of AKT inhibition to address acquired resistance to endocrine therapy and CDK4/6 inhibitors, regardless of a biomarker, and offers a potential new standard of care in second-line therapy for patients with estrogen receptor-driven disease," said Susan Galbraith, executive VP of oncology research and development at AstraZeneca. "We look forward to the submission of the data, with the US FDA granting us a fast-track designation."
For the its next-generation oral selective estrogen receptor degrader camizestrant, Galbraith said the company will soon begin a trial of the drug in the early disease setting. The trial, dubbed CAMBRIA-1, will be an extended adjuvant trial evaluating whether switching from standard endocrine therapy with or without Eli Lilly's Verzenio (abemaciclib) to camizestrant after two to five years improves invasive breast cancer-free survival in patients with ER-positive HER2-negative early breast cancer at high risk of recurrence. "CAMBRIA-1 is a critical opportunity with the potential to increase cure rates in a population at moderate to high risk for metastatic recurrence," Galbraith said.
AstraZeneca is also expanding its lung cancer program with the Phase III AVANZAR trial of Dato-DXd (datopotamab deruxtecan) plus Imfinzi in first-line advanced NSCLC. "This trial allows recruitment of patients regardless of their tumor histology or PD-L1 status and will be the first to use Trop2 as a biomarker in both the primary analysis and as a stratification factor, with co-primary endpoints in both the Trop2 and [intent-to-treat] populations," said Galbraith
In Q4 2022, AstraZeneca posted a net profit of $902 million, or $0.58 per share, compared to a net loss of $346 million, or $0.22 per share, in Q4 2021. The consensus Wall Street estimate was $0.67 per share.
Full-year 2022 revenues were $44.35 billion, a 25 percent increase from $37.42 billion in 2021, and falling just short of analysts' consensus expectations of $44.43 billion.
Over the same period, sales of Tagrisso increased 15 percent to $5.44 billion; sales of Imfinzi grew 21 percent to $2.78 billion; and sales of Lynparza increased 18 percent to $2.64 billion. AstraZeneca recorded $79 million in sales of Enhertu in 2022, more than four times what it recorded in 2021 sales.
AstraZeneca recorded a net profit of $3.29 billion, in 2022, or $2.12 per share, compared to $115 million, or $0.08 per share, in 2021. Analysts on average had projected an EPS of $3.31.
The firm finished the year with $6.17 billion in cash and cash equivalents.