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Amgen Reports Sales Growth Across Precision Oncology Products in Q4


NEW YORK – Amgen is expecting regulators in the US to approve new indications for two bispecific T-cell engagers, Blincyto (blinatumomab) and tarlatamab, in June of this year.

During a call to discuss the company's fourth quarter and full-year 2023 performance on Tuesday evening, Amgen reported growth in sales of its precision oncology products across its portfolio and highlighted these two milestones as part of its plan to grow its presence in oncology in 2024.

For the three months ended Dec. 31, Amgen's overall revenues increased 20 percent to $8.20 billion compared to $6.84 billion in the year-ago quarter, beating the consensus Wall Street estimate of $8.12 billion. Amgen's product sales were $7.83 billion, also up 20 percent compared to $6.55 billion in Q4 2022.

Worldwide sales of the CD19-targeted bispecific T-cell engager Blincyto for previously treated CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) were $241 million, a 47 percent increase from $164 million in Q4 2022. Full-year 2023 sales of Blincyto were $861 million compared to $583 million in 2022, a 48 percent jump.

On the call, Murdo Gordon, Amgen's executive VP of global commercial operations, attributed the sales increase to "broad prescribing to patients with ALL in frontline consolidation treatment."

"Long term, we see significant growth potential for Blincyto from utilization earlier in the frontline as part of induction treatment [for ALL]," Gordon added.

Amgen's KRAS inhibitor Lumakras (sotorasib), approved for KRAS G12C-mutant non-small cell lung cancer, recorded $77 million in revenue in Q4 2023, an 8 percent increase from $71 million during the same period in 2022. Lumakras sales last year, however, dipped 2 percent to $280 million from $285 million in 2022.

Lumakras has faced competition from Mirati Therapeutics' KRAS inhibitor Krazati (adagrasib) since December 2022, when the US Food and Drug Administration approved the latter as another option for patients with advanced KRAS G12C-mutated NSCLC. In December 2023, the FDA declined to convert Lumakras' accelerated approval in this setting to a full approval and asked Amgen to conduct a new postmarket study to confirm Lumakras' benefit.

The firm's EGFR inhibitor Vectibix (panitumumab) for RAS wild-type colorectal cancer brought in $251 million in Q4 2023, compared to $238 million in Q4 2022, a 5 percent increase. Full-year 2023 sales of Vectibix increased 10 percent to $984 million from $893 million in 2022.

Amgen is looking ahead in 2024 to several regulatory milestones. In June, the FDA will decide whether to approve tarlatamab, a DLL3/CD3-targeting bispecific T-cell engager, as a third-line treatment for small cell lung cancer.

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. Boehringer Ingelheim is also developing a DLL3/CD3 bispecific T-cell engager, but unlike Amgen, it is using DLL3 expression to identify SCLC patients who are most likely to benefit. It remains to be seen how the FDA will interpret the biomarker data on these two agents.

Amgen is also expecting the FDA to approve Blincyto in June as a treatment for early-stage, CD19-positive B-cell precursor ALL. Amgen plans to submit Phase III data to the FDA in the first half of this year seeking approval for Lumakras plus Vectibix in patients with chemorefractory KRAS G12C-mutated colorectal cancer.

Additionally, the company is focused on moving its approved oncology products into earlier lines of therapy. Amgen, for example, has begun enrolling older adults with newly diagnosed Philadelphia chromosome-negative B-cell precursor ALL into a Phase III study of Blincyto.

The firm is conducting two Phase III trials evaluating Lumakras in earlier lines of treatment: one of Lumakras plus Vectibix and chemotherapy in first-line KRAS G12C-mutated colorectal cancer and another of Lumakras plus chemotherapy in first-line KRAS G12C-mutated and PD-L1-negative advanced NSCLC.

The company is exploring tarlatamab in earlier lines of therapy, too, Amgen CEO Robert Bradway said on the call. Amgen expects to begin a Phase III study in the first half of 2024 evaluating tarlatamab and AstraZeneca's checkpoint inhibitor Imfinzi (durvalumab) against Imfinzi alone in first-line, extensive-stage SCLC. "We've done this very successfully now with our first [bispecific T-cell engager], Blincyto, which has steadily moved into earlier lines of treatment for acute lymphoblastic leukemia," Bradway said. "And we'll take the same approach with tarlatamab [in SCLC] and yet another promising [bispecific T-cell engager], xaluritamig, in prostate cancer."

In Q4 2023, the firm recorded net income of $767 million, or $1.42 per share, compared to $1.62 billion, or $3.00 per share, in Q4 2022. On a non-GAAP basis, the company reported EPS of $4.71; on average, analysts had expected EPS of $4.60.

In 2023, Amgen's full-year revenues were $28.19 billion, a 7 percent increase from 2022 revenues of $26.32 billion and above analysts' average revenue estimate of $28.15 billion for the year.

The firm's full-year net income was $6.72 billion, or $12.49 per share, compared to $6.55 billion, or $12.11 per share, in 2022. On a non-GAAP basis, the company reported EPS of $18.65 and analysts on average expected full-year EPS of $18.56.

As of Dec. 31, Amgen had $10.94 billion in cash, cash equivalents, and marketable securities.

In 2024, the company is expecting total revenue to be in the range of $32.4 billion and $33.8 billion and EPS between $8.42 and $9.87 on a GAAP basis, and between $18.90 and $20.30 on a non-GAAP basis.