Note: All changes are versus the prior-year period unless otherwise stated
Amgen CEO Robert Bradway said "we achieved solid, volume-driven growth in the quarter as our business recovered from the effects of the [COVID-19] pandemic." However, the company noted that patient visits and lab test procedure trends remain below pre-COVID-19 levels, even though they "continued to improve" throughout the three-month period.
Still, the drugmaker highlighted double-digit volume growth across a number of its products, including Prolia and Repatha, as well as the biosimilars Mvasi and Kanjinti. Further, it noted that its drug Lumakras (sotorasib), recently granted an accelerated approval as the first treatment for patients with KRAS-mutated non-small-cell lung cancer, has been "well received" by the oncology community, and "unaided awareness among oncologists has increased significantly since launch."
Meanwhile, Amgen said the steep decline in its quarterly profit was driven by a write-off of $1.5 billion in acquired in-process R&D associated with its takeover of Five Prime Therapeutics completed this past April.
For the full year, Amgen reaffirmed that it expects adjusted earnings of $16 to $17 per share on revenue of $25.8 billion to $26.6 billion. Still, it says "the cumulative decrease in diagnoses over the course of the pandemic has suppressed the volume of new patients starting treatment, which we expect to continue to impact our business during the second half of the year."
Amgen disclosed that a dose escalation study of its anti-FLT3/CD3 BiTE antibody AMG 427 has paused enrollment of patients with acute myeloid leukaemia, but did not give a reason. It also noted that pavurutamab has resumed enrollment. A Phase I trial of the BCMA-targeting BiTE molecule was paused earlier this year to discuss protocol modifications to optimise safety monitoring and mitigation with the FDA.
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