NEW YORK – While Amgen's overall revenues for the first quarter of 2023 decreased 2 percent to $6.11 billion compared to $6.24 billion in the year-ago quarter, and were below the consensus Wall Street estimate of $6.17 billion, the firm on Thursday reported uniformly strong sales of its precision oncology products.
For the three months ended March 31, Amgen's product sales were $5.85 billion, up 2 percent compared to $5.73 billion in Q1 2022.
Sales of Blincyto (blinatumomab), a treatment for patients with CD19-positive B-cell precursor acute lymphoblastic leukemia, including those who are in first or second complete remission with minimal residual disease negative, contributed $194 million to Q1 2023 revenues, up 41 percent from $138 million in Q1 2022. During a conference call Thursday to discuss the company's financial results, Murdo Gordon, Amgen executive VP of global commercial operations, said sales of Blincyto were supported by "strong adoption" across academic and community cancer centers following positive data from the registration-enabling Phase III E1910 clinical trial.
In December, Amgen reported results from the trial showing that Blincyto added to consolidation chemotherapy led to superior overall survival in MRD-negative patients with newly diagnosed Philadelphia chromosome-negative B-lineage acute lymphoblastic leukemia compared to multiagent consolidation chemotherapy, the current standard of care. David Reese, Amgen executive VP of R&D, said on the call that the company is planning global regulatory submissions in the second half of 2023 based on this data. "We are investing to move Blincyto into earlier lines of treatment and to improve patient convenience through subcutaneous administration," he added.
Sales of Lumakras (sotorasib), a treatment for KRAS G12C-mutated advanced non-small cell lung cancer, which has been approved in 50 countries, were $74 million in Q1 2023, up 19 percent compared to $62 million in Q1 2022. Amgen sold 40 percent more of the drug by volume during the quarter year over year, but this was partially offset by a lower net selling price, Reese explained.
Reese noted that Amgen is exploring combination therapeutic strategies with Lumakras in two Phase III trials. The CodeBreak 300 trial of Lumakras plus Amgen's Vectibix (panitumumab) as a third-line therapy in patients with KRAS G12C-mutated colorectal cancer is fully enrolled, and Amgen is expecting a data readout in the second half of 2023, according to Reese. Amgen also plans to begin a Phase III trial of Lumakras with chemotherapy in the first-line non-small cell lung cancer setting. Lastly, results from a study of Lumakras plus standard-of-care chemotherapy in NSCLC and Lumakras plus Vectibix and standard-of-care chemotherapy in colorectal cancer will be presented in June at the American Society of Clinical Oncology's annual meeting.
"We also completed submission of the Lumakras CodeBreak 200 data along with data from the Phase II dose comparison sub-study to the [US Food and Drug Administration] and to the European Medicines Agency," said Reese.
Sales of Vectibix, which is sold as a treatment for RAS wild-type colorectal cancer, increased 16 percent during Q1 2023 to $233 million versus $201 million in Q1 2022.
The firm recorded net income of $2.84 billion, or $5.28 per share, compared to $1.48 billion, or $2.68 per share, in Q1 2022. On a non-GAAP basis, the company reported EPS of $3.98; on average, analysts had expected EPS of $3.85.
In 2023, the company is expecting total revenue to be in the range of $26.2 billion to $27.3 billion and EPS between $15.38 and $16.59, or between $17.60 and $18.70 on a non-GAAP basis. The guidance doesn't include the impact of Amgen's recent acquisition of Horizon Therapeutics, slated to close in the first half of this year.
As of March 31, Amgen had $31.56 billion in cash, cash equivalents, and marketable securities.