Skip to main content
Premium Trial:

Request an Annual Quote

AstraZeneca's Q3 Oncology Revenues Grow 18 Percent

NEW YORK – AstraZeneca said on Friday that revenues from its oncology business increased 18 percent compared to the same period last year, driven by strong sales from several precision oncology drugs including osimertinib (Tagrisso), olaparib (Lynparza) and trastuzumab deruxtecan (Enhertu).

For the three months ended Sept. 30, the drugmaker reported total revenues of $9.87 billion, marking a 50 percent increase compared to Q3 2020. On average, analysts had expected revenues of $9.58 billion. A chunk of the revenue growth during the quarter was due to sales of AstraZeneca's COVID-19 vaccine. Minus that, the company's revenues for the quarter were $8.82 billion, a 34 percent increase from the prior-year period.

The company's oncology segment contributed 34 percent of total revenues and brought in $3.38 billion during Q3 2021.

Osimertinib, a drug for EGFR-mutated non-small cell lung cancer, was AstraZeneca's top-selling cancer therapy during the quarter, bringing in $1.25 billion in sales during Q3 2021, an 8 percent increase from Q3 2020. However, sales of the drug were down sequentially by around 5 percent compared to sales of $1.31 billion in Q2 2021.

Sales of osimertinib in China were impacted by inventory phasing related to recent changes in the country's National Reimbursement Drug List, a program started in 2000 to improve access and reimbursement to hospital-purchased drugs. In the future, "we expect volume growth [in first and second-line settings] to offset the significant price reduction that we took only six months ago," Dave Fredrickson, executive VP of AstraZeneca's oncology business unit, said during a conference call to discuss the company's financial performance.

In the second quarter, sales of the drug benefitted from more patients in China switching to Tagrisso from first-generation drugs, but this benefit didn't translate to the third quarter. Meanwhile, sales of AstraZeneca's first-generation EGFR inhibitor for NSCLC, gefitinib (Iressa), declined 23 percent to $41 million.

The PARP inhibitor olaparib, approved for breast, ovarian, and other tumors harboring BRCA1/2 mutations or homologous recombination repair deficiencies (HRD), contributed $588 million in sales, a 27 percent increase from Q3 2020. According to Fredrickson, sales in the US were driven by greater use in ovarian and prostate cancer, and in adjuvant breast cancer.

During the second quarter, the Phase III OlympiA trial showed that breast cancer patients with BRCA1/2 mutations on adjuvant olaparib had significantly improved invasive disease-free survival rates compared to those on placebo. Since then, the American Society of Clinical Oncology and the National Comprehensive Cancer Network have both recommended adjuvant olaparib in guidelines, which will support increased use in this setting.

In Europe and the rest of the world, olaparib sales grew in ovarian and prostate cancer settings, "supported by continued growth in HRD testing," Fredrickson said.

Trastuzumab deruxtecan, for which AstraZeneca has a codevelopment and commercialization deal with Daiichi Sankyo, netted $57 million in the third quarter; there wasn't a material difference in sales from the year-ago quarter. The US Food and Drug Administration approved trastuzumab deruxtecan as a third-line option for advanced, HER2-positive breast cancer in 2019, and earlier this year, expanded the drug's indication to HER2-positive gastric cancer. Over three quarters in 2021, the drug brought in $147 million in sales, driven by the third-line breast cancer indication and a strong launch in second-line gastric cancer.

At the European Society for Medical Oncology's annual meeting this year, AstraZeneca unveiled data from the Destiny-Breast03 trial, comparing trastuzumab deruxtecan head to head with Genentech's ado-trastuzumab emtansine (Kadcyla; T-DM1). The study showed that previously treated, metastatic HER2-positive breast cancer patients on trastuzumab deruxtecan had median progression-free survival of 75.8 percent versus 34.1 percent in the T-DM1 arm.

"Enhertu truly has the capacity to change the standard of care by demonstrating superior benefit over T-DM1 in patients with HER2-positive metastatic breast cancer in the second line," Susan Galbraith, AstraZeneca's executive VP of oncology R&D, said during the call. Fredrickson added that these data, if received favorably by regulators, will allow AstraZeneca to take a leadership position in the second-line setting.

AstraZeneca will soon launch a new trial, called Destiny-Breast04, comparing trastuzumab deruxtecan against investigator's choice of treatment for breast cancer patients with low HER2-expressing tumors that have spread or can't be surgically removed. The trial will test out trastuzumab deruxtecan's so-called "bystander effect," which describes the observed ability of the drug's cytotoxic payload to kill nearby cancer cells that are HER2-negative.

Galbraith said past studies have shown that the design of the antibody-drug conjugate allows it to have efficacy in a range of HER2 low-expressing tumor types beyond breast cancer. "Across the totality of the program, in a range of tumors that have lower HER2 expression than the highly amplified, you're seeing a range of activities beyond what you would have expected from prior designs of [antibody-drug conjugates]," she said.

Meanwhile, savolitinib (Orpathys), a MET inhibitor that AstraZeneca has developed with Hutchmed for NSCLC patients who have progressed on systemic therapy, are unable to receive chemotherapy, and harbor MET exon 14 skipping tumor alterations, generated $10 million in sales during Q3. The drug was granted conditional approval from China's National Medical Products in the prior quarter.

AstraZeneca recorded a loss of $1.65 billion, or $1.10 per share, in Q3 2021, compared to a profit $651 million, or $.49 per share, in Q3 2020. Core non-GAAP EPS during the quarter was $1.08. On average, analysts had expected an EPS of $.91.

The firm's R&D expense more than doubled to $3.61 billion in Q3 2021 compared to $1.50 billion in the prior-year period. It's selling, general, and administrative expenses were $4.09 billion in the quarter, growing 50 percent from $2.73 billion in Q3 last year.

As of Sept. 30, AstraZeneca had $7.07 billion in cash and cash equivalents.

The company maintained its prior 2021 revenue guidance. It is expecting 2021 revenues to increase by a low-20s percentage and its core EPS to grow in the range of $5.05 to $5.40.