NEW YORK – In the second half of 2024, Amgen is expecting a second regulatory approval for its KRAS inhibitor Lumakras (sotorasib) and will advance clinical trials for two cancer drugs, the PRMT5 inhibitor AMG 193 and anti-FGFR2b agent bemarituzumab.
These upcoming milestones come after Amgen's bispecific T-cell engager Blincyto (blinatumomab) was approved in the second quarter as a consolidation treatment for adult and pediatric patients with CD19-positive, Philadelphia chromosome (Ph)-negative B-cell precursor acute lymphoblastic leukemia (B-ALL).
On a call Tuesday with investors to discuss Q2 financials, Amgen CSO James Bradner said the firm is focused on developing differentiated therapies for "high-conviction targets." Its pipeline of investigational cancer drugs currently includes bispecific T-cell engagers, small molecules, monoclonal antibodies, and immune cell-focused XmAb antibodies.
Among Amgen's top-selling oncology products, Blincyto grew the most in Q2 2024 with sales of $264 million, a 28 percent increase compared to $206 million in Q2 2023. Murdo Gordon, executive VP of global commercial operations at Amgen, attributed the growth to "broad prescribing across academic and community segments." Gordon added that the firm has been engaging academic, regional, and community oncology settings since the drug's approval in June to "establish Blincyto as a standard-of-care" consolidation treatment for CD19-positive, Ph-negative B-ALL.
"We continue to seek to expand the impact of Blincyto in newly diagnosed B-ALL through ongoing studies and with the further investigation of subcutaneous administration," Gordon added.
KRAS inhibitor Lumakras, which is currently approved for KRAS G12C-mutant advanced or metastatic non-small cell lung cancer, generated $85 million in sales in Q2 2024, a 10 percent increase compared to $77 million during the same period last year. Gordon noted there are still further growth opportunities for Lumakras in new markets and in additional indications.
The US Food and Drug Administration is expected to decide by Oct. 17 whether to approve Lumakras combined with Amgen's EGFR inhibitor Vectibix (panitumumab) as a treatment for KRAS G12C–mutated metastatic colorectal cancer.
The firm reported $270 million in revenue from its EGFR inhibitor Vectibix, sold as a treatment for RAS wild-type metastatic colorectal cancer, a 9 percent increase from $248 million in the year-ago quarter.
Overall, Amgen's revenues for the three months ended June 30 were $8.39 billion, a 20 percent increase from $6.99 billion in Q2 2023. The company beat the Wall Street consensus revenue estimate of $8.33 billion.
In Q2 2024, the firm recorded net income of $746 million, or $1.38 per share, compared to net income of $1.38 billion, or $2.57 per share, in Q2 2023. On a non-GAAP basis, the company reported EPS of $4.97, missing the consensus Wall Street EPS expectation of $5.01.
Amgen spent $1.45 billion on R&D in the quarter, a 30 percent increase from $1.11 billion in the same period last year. Amgen CFO Peter Griffith noted that this increased spending was due to the costs of advancing its late-stage candidates, including bemarituzumab. The firm spent $1.79 billion on selling, general, and administrative expenses in Q2 2024, a 38 percent increase from $1.29 billion in Q2 2023. Griffith attributed this spending increase to costs associated with Amgen's acquisition of Horizon Therapeutics, which it completed last October.
Later this year, Amgen expects to advance clinical trials of its investigational precision oncology candidates AMG 193 and bemarituzumab. For the PRMT5 inhibitor AMG 193, the firm will report dose-escalation and dose-expansion data at the European Society for Medical Oncology meeting next month from a Phase I trial of the drug in MTAP-null solid tumors. Amgen is also continuing to enroll patients in this monotherapy trial and in studies testing AMG 193 with chemotherapy or immunotherapy.
Amgen has also completed enrollment in a Phase III trial testing bemarituzumab plus chemo against placebo plus chemo in previously untreated, advanced gastric or gastroesophageal junction cancer with FGFR2b overexpression. In this same patient population in another Phase III study, the firm is evaluating bemarituzumab plus chemo against Bristol Myers Squibb's immunotherapy Opdivo (nivolumab) plus chemo.
As of June 30, Amgen reported $9.3 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. The firm now expects revenue in the range of $32.8 billion to $33.8 billion and non-GAAP EPS between $19.10 and $20.10. Previously, Amgen was expecting between $32.5 billion and $33.8 billion in 2024 revenue and non-GAAP EPS between $19.00 and $20.20.