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Amgen's Lumakras Reports Double-Digit Sales Growth in Q1

NEW YORK – Amgen on Thursday reported that its oncology unit generated more than $2 billion in global sales in Q1 2024, as overall revenue increased by 22 percent.

During a call to discuss the company's first quarter performance on Thursday evening, Amgen reported overall revenue of $7.45 billion compared to $6.11 billion in the year-ago quarter, beating the consensus Wall Street estimate of $7.44 billion. Amgen's product sales were $7.12 billion, also up 22 percent compared to $5.85 billion in Q1 2023.

Worldwide sales of Blincyto (blinatumomab), a CD19-targeted bispecific T-cell engager for previously treated CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL), were $244 million in the first quarter, a 26 percent increase from $194 million in Q1 2023.

The firm's EGFR inhibitor Vectibix (panitumumab) for RAS wild-type colorectal cancer brought in $247 million in Q1 2024, compared to $233 million in Q1 2023, a 6 percent increase.

Amgen's KRAS inhibitor Lumakras (sotorasib), approved for KRAS G12C-mutant non-small cell lung cancer, recorded $82 million in revenue in Q1 2024, an 11 percent increase from $74 million during the same period in 2023.

Amgen had previously said that in the first half of this year, it would seek marketing approval from the US Food and Drug Administration for Lumakras plus Vectibix as a treatment for patients with chemo-refractory KRAS G12C-mutated colorectal cancer based on Phase III data showing that the combo improved outcomes versus standard-of-care treatments. Amgen has not yet made the submission.

In February, Bristol Myers Squibb submitted an application seeking FDA approval for Lumakras competitor Krazati (adagrasib) plus Eli Lilly's EGFR inhibitor Erbitux (cetuximab) in this same indication. Krazati, which came to BMS when it completed its acquisition of Mirati Therapeutics in January, recorded $21 million in sales in Q1 2024.

Looking ahead, Amgen is expecting two FDA decisions in June: a potential first approval for tarlatamab, a DLL3/CD3-targeting bispecific T-cell engager, as a third-line treatment for small cell lung cancer; and an expanded indication for Blincyto as a treatment for early-stage, CD19-positive B-cell precursor ALL.

Amgen is seeking approval for tarlatamab in an all-comer SCLC population because most SCLC patients have some level of DLL3 tumor expression and an exploratory analysis showed that even some patients who didn't have the tumor biomarker responded to the drug.

Murdo Gordon, executive VP of global commercial operations at Amgen, said on a call to discuss the firm's Q1 financial performance that it is preparing for tarlatamab's potential approval by training medical and field sales teams and planning physician outreach programs as it continues research to move the drug into earlier lines of therapy.

"The treatment of this disease has not meaningfully evolved [in years]," said Amgen CSO Jay Bradner on the call. "This is a case where time can't move fast enough to get this medicine into earlier lines of therapy."

He added that the firm has now initiated three Phase III trials of tarlatamab: in the second-line SCLC setting; after first-line chemotherapy in limited-stage SCLC; and in combination with AstraZeneca's checkpoint inhibitor Imfinzi (durvalumab) as a first-line treatment for extensive-stage SCLC.

This year, Amgen is also advancing studies of another bispecific T-cell engager, xaluritamig, and a PRMT5 inhibitor, AMG 193. Bradner said Amgen will soon begin the dose-expansion portion of the Phase I/II trial of xaluritamig in metastatic castration-resistant prostate cancer. He added that the firm is planning additional combination therapy trials of AMG 193 in thoracic tumors with homozygous MTAP-deletion and in MTAP-deleted gastrointestinal, biliary tract, and pancreatic tumors.

In Q1 2024, the firm recorded a net loss of $113 million, or $.21 per share, compared to net income of $2.84 billion, or $5.28 per share, in Q1 2023. On a non-GAAP basis, the company reported an EPS of $3.96, exceeding the consensus Wall Street EPS expectation of $3.87.

Amgen CFO Peter Griffith noted during the call that the change in cash flow in Q1 was due to a previously announced $800 million payment the firm made to the US Internal Revenue Service as the agency investigates alleged underreporting of taxable income and as Amgen faces a class-action lawsuit for not promptly disclosing the dispute with the IRS to investors.

As of March 31, Amgen had $9.71 billion in cash and cash equivalents.

The company partially revised its 2024 guidance, slightly increasing the low end of its total revenue expectation and raising its guidance for non-GAAP EPS. The firm now expects revenue in the range of $32.5 billion and $33.8 billion and non-GAAP EPS between $19.00 and $20.20.