Amgen Raises FY23 Outlook, Discloses Brief Readout From Tarlatamab Lung Cancer, Lumakras Colorectal Cancer Studies

Amgen Inc AMGN reported Q2 FY23 sales of $6.99 billion, up 7% Y/Y, beating the consensus of $6.63 billion.

Product sales increased 6%, driven by 11% volume growth, partially offset by a 2% lower net selling price, 1% lower inventory levels, and 1% negative impact from foreign exchange.

Adjusted EPS of $5.00 increased 8%, beat the consensus of $4.44.

The company released topline data from tarlatamab Phase 2 DeLLphi-301 study in relapsed or refractory small-cell lung cancer.

• Tarlatamab demonstrated a durable objective response rate (ORR) (primary endpoint), exceeding the previously reported in the Phase 1 study. 
• Safety and tolerability were also more favorable than in the Phase 1 study, with no new safety signals identified. 

Amgen also said its KRAS-blocking drug Lumakras succeeded in the Phase 3 CodeBreaK 300 trial, delaying the progression of chemorefractory metastatic KRAS G12C mutated colorectal cancer.

• Both tested doses, 240 mg and 960 mg, of Lumakras met the trial’s primary endpoint of progression-free survival. 
• The study pitted a combination of Lumakras and Vectibix against physicians’ choice of one of two older colorectal cancer therapies in patients who had previously received chemotherapy.
• In its short update, Amgen said Lumakras’ efficacy in the trial was “consistent” with the 2021 data and showed no new safety signals.

Amgen announced discontinuing further enrollment in the study of Lumakras combined with a PD-1 inhibitor in KRAS G12C mutated NSCLC.

Guidance: Amgen expects FY23 revenue of $26.6-$27.4 billion versus the previous range of $26.2-$27.3 billion and consensus of $26.56 billion.

The company sees adjusted EPS of $17.80-$18.80 compared to $17.60-$18.70 expected earlier and the Wall Street estimate of $17.75.

Price Action: AMGN shares are down 1.43% at $234 during the premarket session on the last check Friday.