NEW YORK – AstraZeneca said on Thursday before markets opened that revenues from its oncology business increased 19 percent compared to the same period last year, driven by strong sales from osimertinib (Tagrisso).
For the three months ended June 30, the drugmaker reported total revenues of $8.22 billion, marking a 31 percent increase compared to Q2 2020, thanks to the positive impact from its COVID-19 vaccine. Excluding sales of its COVID-19 vaccine, the company's revenues for the quarter were $7.33 billion, a 17 percent increase from the prior-year period. Analysts' consensus revenue estimate was $7.36 billion.
Despite continued market uncertainties due to the pandemic, AstraZeneca CEO Pascal Soriot said the firm had a strong financial performance during the quarter and attributed it to growth in all regions and disease areas, including oncology, which recorded $3.34 billion in Q2 2021 sales, comprising 41 percent of total revenues.
During a call to discuss the quarterly financials, Dave Fredrickson, AstraZeneca's executive VP of the oncology business unit, highlighted osimertinib's adjuvant availability during the quarter not just in the US but also in China and in Europe as a growth driver in the oncology segment. Executives noted that while demand for osimertinib and other cancer drugs is recovering, it is not back to pre-COVID levels.
Still, osimertinib, a drug for EGFR-mutated non-small cell lung cancer, was AstraZeneca's top-selling cancer therapy during the quarter. The US Food and Drug Administration approved the EGFR inhibitor last December as an adjuvant NSCLC treatment, adding to its existing indication in the metastatic setting, and regulators in other countries followed suit. The drug brought in $1.31 billion in sales during Q2 2021, a 26 percent increase from Q2 2020.
Other notable precision oncology drugs in AstraZeneca's oncology portfolio include the PARP inhibitor olaparib (Lynparza), approved for breast, ovarian, and other tumors harboring BRCA1/2 mutations or homologous recombination repair deficiencies; and trastuzumab deruxtecan (Enhertu), the HER2-targeted breast and gastric cancer therapy, for which AstraZeneca has a codevelopment and commercialization deal with Daiichi Sankyo.
Olaparib sales grew 40 percent year over year to $588 million in the quarter. Fredrickson attributed sales increases in the US to growing traction of the prostate cancer indication and in Europe to good performance in the first-line ovarian and prostate cancer indications.
"There's been significant momentum in homologous recombination deficiency testing," Fredrickson said. In the US, Myriad Genetics' myChoice CDx is approved by the FDA to identify advanced ovarian cancer patients with homologous recombination repair deficiencies, including BRCA1/2 mutations, who are eligible to receive olaparib in combination with bevacizumab (Roche/Genentech's Avastin).
"HRD testing has increased in the US, Europe, and in Japan, which has meant that more patients have benefited from personalized treatment with Lynparza," said Fredrickson.
In the Phase III PROpel trial, AstraZeneca is exploring the activity of olaparib with abiraterone as a first-line treatment in a genetically unselected, metastatic castration-resistant prostate cancer population, though researchers will conduct exploratory analysis in the subgroup with homologous recombination repair gene mutations. Fredrickson noted that olaparib has a blockbuster opportunity if PROpel successfully shows benefit in an all-comer population and the indication isn't limited to the biomarker-defined group. The data from this study is slated to read out later this year.
Under its deal with Daiichi Sankyo, AstraZeneca largely records trastuzumab deruxtecan sales as collaboration revenue. Fredrickson said that in the first half of the year, AstraZeneca recorded $89 million in total revenues from trastuzumab deruxtecan. Global sales of the drug, excluding Japan, for H1 2021 recorded by Daiichi Sankyo were $183 million.
Meanwhile, sales of the company's first-generation EGFR inhibitor for NSCLC, gefitinib (Iressa), declined 34 percent to $47 million.
During Q2, China's National Medical Products Administration granted conditional approval to 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. The drug didn't generate any revenue during the quarter.
AstraZeneca recorded a profit of $550 million, or $.42 per share, in Q2 2021, compared to $738 million, or $.58 per share, in Q2 2020. The company's core EPS was $.90 for the quarter. On average, analysts had estimated an EPS of $.43.
The firm's R&D expense grew 32 percent to $1.83 billion in Q2 2021 compared to $1.39 billion in the prior-year period. The increase, AstraZeneca said, reflects the company's investments into its COVID-19 vaccine and its continued research to develop new treatments against SARS-CoV-2. It's selling, general, and administrative expenses were $3.1 billion in the quarter, growing 18 percent from $2.64 billion in Q2 last year.
AstraZeneca updated its guidance following its recently closed acquisition of Alexion, enabling expansion into immunology and rare diseases. The company said it is expecting 2021 revenues to increase by a low-20s percentage and its core EPS to grow faster in the range of $5.05 to $5.40.