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AstraZeneca Q1 Oncology Product Sales Increase 14 Percent Led by Tagrisso

NEW YORK – AstraZeneca on Friday said that in the first quarter of 2022 revenues from its therapeutic products grew 51 percent, bolstered by the performance of several precision oncology drugs.

For the three months ended March 31, the company reported a 56 percent increase in total revenues to $11.39 billion compared to $7.32 billion during the same period in 2021 and coming in above the average Wall Street estimate of $10.99 billion. AstraZeneca's therapeutic products contributed $11.0 billion during Q1 2022 compared to $7.26 billion during Q1 last year.

The firm also had $410 million from collaboration revenue during the quarter. This segment included a $76 million payment for Enhertu (trastuzumab deruxtecan) and a $175 million milestone payment for the PARP inhibitor Lynparza (olaparib), triggered by its approval in the US in March as an adjuvant treatment for early-stage breast cancer patients with germline BRCA1/2 mutations based on the OlympiA study. AstraZeneca comarkets and codevelops Enhertu with Daiichi Sankyo and it shares rights to Lynparza with Merck.

Revenues from the oncology segment in Q1 2022 totaled $3.64 billion, comprising nearly a third of the company's total revenues and marking a 21 percent increase over Q1 2021. The revenues in this segment included a milestone payment, without which oncology product sales during the quarter increased 14 percent, despite lower cancer diagnosis and treatment rates due to the COVID-19 pandemic.

The EGFR-inhibiting lung cancer treatment Tagrisso (osimertinib) continued to be AstraZeneca's top-selling oncology product in Q1 2022, with revenues growing 14 percent to $1.30 billion from the prior year's quarter. The company is looking to expand the drug's indications, such as for refractory, advanced non-small cell lung patients who have already received and progressed on Tagrisso due to acquired MET overexpression or amplifications.

Researchers are exploring the activity of Tagrisso with Hutchmed's MET inhibitor Orpathys (savolitinib) in this subset of patients and comparing the combination to platinum-based doublet chemotherapy in the SAFFRON trial. Hutchmed and AstraZeneca will begin enrolling patients in this study in mid-2022.

During Q1 2022, Lynparza, approved for breast, ovarian, and other tumors harboring BRCA1/2 mutations or homologous recombination repair deficiencies (HRD), brought in sales of $617 million, marking a 14 percent increase over the same period in 2021.

Enhertu, sold as a treatment for HER2-positive advanced breast and gastric cancer, brought in revenues of $86 million in Q1 2022, more than double the revenue AstraZeneca recorded for the drug in Q1 2021. Global in-market sales (excluding Japan) of antibody-drug conjugate recorded by AstraZeneca and Daiichi Sankyo increased 105 percent to $166 million compared to $81 million in the year-ago period. Daiichi Sankyo recorded US in-market Enhertu sales of $119 million in Q1 2022, a 63 percent increase compared to $73 million in Q1 last year. In Japan, AstraZeneca receives a mid-single digit percentage royalty on Enhertu sales recorded by Daiichi Sankyo.

During a call to discuss the company's financial performance, AstraZeneca executives highlighted plans to develop Enhertu for HER2-low metastatic breast cancer patients, who are currently not eligible for HER2-targeted treatment. Patients in this subset with hormone receptor (HR)-positive and -negative disease comprise half of all breast cancer cases, and chemotherapy is often their only option in the metastatic setting. AstraZeneca and Daiichi Sankyo this week announced that the FDA has granted Enhertu breakthrough therapy designation as a treatment for patients with unresectable or metastatic HER2-low breast cancer who have received systemic therapy and recurred within six months of undergoing adjuvant chemotherapy.

The FDA granted the designation based on data from the Phase III DESTINY-Breast04 trial, which showed that Enhertu-treated patients with HER2-low advanced breast cancer had a statistically significant improvement in progression-free and overall survival compared to those on physicians' choice of chemotherapy. AstraZeneca executives said they will present data from DESTINY-Breast04 during a plenary session at the American Society of Clinical Oncology's annual meeting in June and discuss the findings with regulatory authorities around the world. 

According to Susan Galbraith, AstraZeneca's executive VP of oncology R&D, Enhertu is the first anti-HER2 drug to demonstrate benefit in patients with low HER2-expressing cancers. This is a "historic landmark in clinical development with the capacity to change how breast cancer is categorized," Galbraith said during the call. She added that based on the findings from DESTINY-Breast04, AstraZeneca has greater confidence in the outcome of DESTINY-Breast06, where researchers are comparing Enhertu against chemotherapy in HER2-low and -ultra low, HR-positive metastatic breast cancer patients who have progressed on endocrine therapy. Data from this trial will read out in 2023.

AstraZeneca is also exploring the activity of Enhertu in other tumor types, such as the 2 percent of non-small cell lung cancers that harbor HER2 mutations. "These patients are typically female, never smokers, but have a poorer prognosis and a higher rate of brain metastases when compared to those without HER2 mutations," Galbraith said. The firm is studying Enhertu in this setting within the DESTINY-Lung01 trial.

In Q1 2022, AstraZeneca recorded a profit of $388 million, or $.25 per share, compared to a profit $1.56 billion, or $1.19 per share, in Q1 2021. Core EPS during the quarter was $1.89. On average, analysts had expected EPS of $.83.

The firm's R&D expense increased 24 percent to $2.13 billion in Q1 2022, compared to $1.71 billion in the prior-year period. It's selling, general, and administrative expenses were $4.84 billion in the quarter, growing 65 percent from $2.93 billion in Q1 last year.

As of March 31, AstraZeneca had $5.76 billion in cash and cash equivalents.

As previously stated, the company expects its revenues this year will increase by a high-teens percentage at constant exchange rates and core EPS will increase by a mid-to-high twenties percentage.