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Amgen Sees Strong Growth for Precision Oncology Drugs in Q3

NEW YORK – Amgen reported significant revenue growth in the third quarter of 2024 for two of its precision oncology drugs, the KRAS inhibitor Lumakras (sotorasib) and the bispecific T-cell engager Blincyto (blinatumomab), as overall revenues increased 23 percent year over year.

Amgen's overall revenues for the three months ended Sept. 30 were $8.50 billion compared to $6.90 billion in Q3 2023. The company missed the Wall Street consensus revenue estimate of $8.52 billion for Q3.

The Thousand Oaks, California-based firm's oncology products generated more than $2 billion in sales in Q3, Murdo Gordon, executive VP of global commercial operations at Amgen, said on a call Wednesday with investors and market analysts to discuss the financials. Several of its precision oncology products contributed to sales growth in that segment.

Lumakras' worldwide sales climbed 88 percent to $98 million in Q3 2024 compared to $52 million in Q3 2023. Lumakras is currently approved for the treatment of KRAS G12C-mutant advanced or metastatic non-small cell lung cancer. Amgen has also submitted an application to the US Food and Drug Administration seeking approval for Lumakras in combination with its EGFR-inhibiting monoclonal antibody Vectibix (panitumumab) for KRAS G12C-mutated chemorefractory, metastatic colorectal cancer. Amgen also presented early data last month on the activity of Lumakras combined with Vectibix and chemo in the first-line setting for KRAS G12C-mutant colorectal cancer.

The firm said the FDA has extended its review timeline for the application seeking approval for Lumakras-Vectibix in previously treated KRAS G12C-mutated metastatic colorectal cancer so it can consider recently submitted supplemental data. The agency now expects to decide on approval by Jan. 17, 2025. European regulators are also reviewing data for Lumakras in previously treated, locally advanced or metastatic KRAS G12C-mutated NSCLC, Amgen said.

Global Blincyto revenues in Q3 2024 were $327 million, a 49 percent increase from $220 million during the same period last year. The drug gained an additional indication in the US in June as a consolidation treatment for adult and pediatric patients with CD19-positive, Philadelphia chromosome (Ph)-negative B-cell precursor acute lymphoblastic leukemia. It was previously approved in 2023 for patients with minimal residual disease (MRD)-positive, CD19-positive B-cell precursor acute lymphoblastic leukemia who are in their first or second remission. Blincyto's sales growth in Q3 2024 was supported by this expanded indication, according to Gordon.

Amgen's Vectibix, a treatment for RAS wild-type metastatic colorectal cancer, generated revenues of $282 million globally in Q3 2024, a 12 percent increase from $252 million in Q3 2023.

In the third quarter, Amgen continued advancing two of its investigational precision oncology drugs, PRMT5 inhibitor AMG 193 and anti-FGFR2b agent bemarituzumab, into later stage trials. In Q3, the firm began a Phase II trial of AMG 193 in patients with MTAP-null, previously treated, advanced NSCLC. Amgen also reported data last month from a Phase I trial of AMG 193 in MTAP-null solid tumors, demonstrating a 21 percent response rate.

The Phase II trial of AMG 193 in NSCLC will "help to address regulatory agency requirements for dose optimization and selection," Amgen CSO James Bradner said on the call.

Amgen is advancing several studies of bemarituzumab. The firm is testing the activity of the drug with chemo and with immunotherapy in first-line gastric cancer. It has also begun a Phase Ib/II basket study of bemarituzumab monotherapy in patients with solid tumors overexpressing FGFR2b.

In Q3 2024, the firm recorded net income of $2.83 billion, or $5.22 per share, compared to net income of $1.73 billion, or $3.22 per share, in Q3 2023. On a non-GAAP basis, the company reported EPS of $5.58, beating the consensus Wall Street EPS expectation of $5.11.

Amgen spent $1.45 billion on R&D in the quarter, a 34 percent increase from $1.08 billion in the same period last year. The firm spent $1.63 billion on selling, general, and administrative expenses in Q3 2024, a 20 percent increase from $1.35 billion in Q3 2023. Amgen CFO Peter Griffith attributed this spending increase to costs associated with Amgen's acquisition of rare disease-focused pharma company Horizon Therapeutics, which it completed last year.

As of Sept. 30, Amgen had $9.01 billion in cash and investments.

The company partially revised its 2024 guidance, slightly increasing the low end of its total revenue expectation and narrowing its guidance for non-GAAP EPS for the year. The firm now expects 2024 revenue in the range of $33 billion to $33.8 billion and non-GAAP EPS between $19.20 and $20.00. Previously, Amgen was expecting between $32.8 billion and $33.8 billion in 2024 revenue and non-GAAP EPS between $19.10 and $20.10.