NEW YORK – Pfizer's oncology business reported strong growth in Q4 as the firm looks ahead to further expansion of its breast cancer and antibody-drug conjugate franchises alongside potential financial impacts from the US Inflation Reduction Act (IRA).
The firm's oncology business had Q4 revenues of $4.06 billion compared to $3.19 billion in Q4 2023, a 27 percent increase. The oncology products gained in the 2023 Seagen acquisition, including Tukysa (tucatinib) and antibody-drug conjugates Padcev (enfortumab vedotin) and Adcetris (brentuximab vedotin), reported growth greater than 100 percent in Q4 due to the acquisition being completed in December 2023, which resulted in Pfizer only recording sales for these products for part of the quarter.
"We successfully integrated the Seagen business [in 2024], one of the largest investments we have made in the past decade, creating one of the best oncology companies in the industry," Pfizer CEO Albert Bourla said during a call to discuss Q4 financial results.
For the three months ended Dec. 31, Pfizer reported total revenues of $17.76 billion, a 22 percent increase from $14.57 billion in the year-ago period. The company beat the Wall Street consensus revenue estimate of $17.26 billion for the quarter.
Pfizer's top-selling oncology drug, CDK4/6 inhibitor Ibrance (palbociclib), recorded worldwide revenues of $1.10 billion in Q4, compared to $1.19 billion in Q4 2023, a 2 percent drop. Last month, the US Centers for Medicare & Medicaid Services (CMS) selected Ibrance as one of the drugs for discussions under the IRA's Medicare Drug Price Negotiation Program. Several other Pfizer drugs have also been selected for IRA price negotiations, including its prostate cancer treatment Xtandi (enzalutamide).
"The impact of the IRA Medicare Part D redesign is expected to be a net headwind to the company's revenue of approximately $1 billion across our product portfolio, dampening growth by approximately 1.6 percent versus 2024," Pfizer CFO David Denton said on the call with investors on Tuesday.
As Ibrance revenues have continued to decrease and are expected to be affected by IRA negotiations, the firm is focused on advancing two investigational candidates in breast cancer: the CDK4 inhibitor atirmociclib and the estrogen receptor degrader vepdegestrant.
Bourla said that this week researchers began treating patients in a Phase III trial of atirmociclib, also called PF-07220060, with letrozole in the first-line setting for hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients. He added that the firm expects to start another trial this year of vepdegestrant in the first-line setting for breast cancer.
Chris Boshoff, CSO and president of research and development at Pfizer, said on the call that the firm has a lot of "optionality" for its breast cancer franchise.
"We believe [atirmociclib] is a best-in-class CDK4 inhibitor," Boshoff said. "We are very optimistic that [atirmociclib] could not only replace Ibrance but all CDK4/6 inhibitors in early-line breast cancer including first line and potentially in the future in the adjuvant setting. Vepdegestrant potentially could become the replacement for backbone endocrine treatment."
Several precision oncology products reported growth of 30 percent or more in Q4. The ALK inhibitor Lorbrena (lorlatinib) for ALK-rearranged metastatic non-small cell lung cancer had global revenues of $192 million in the fourth quarter, a 32 percent increase from Q4 2023 sales of $146 million. Bourla noted that the growth was driven by the drug's increased market share in the first-line setting after results from the CROWN trial last year showed a median progression-free survival greater than five years for first-line ALK-positive NSCLC patients on Lorbrena.
"[Lorbrena] is emerging as a potential standard of care in the first-line setting," Bourla said. "Following the unprecedented CROWN trial data … Lorbrena has seen a double-digit share increase in the first line in both new patient starts and new prescribers."
Pfizer's BRAF and MEK inhibitor combination, Braftovi (encorafenib) and Mektovi (binimetinib), together brought in $170 million in Q4, a 30 percent increase from $131 million in Q4 2023. The firm recently reported positive Phase III data from a trial of Braftovi and Mektovi with Eli Lilly's EGFR inhibitor Erbitux (cetuximab) and chemo in the first-line setting for BRAF V600E-mutant metastatic colorectal cancer.
The PARP inhibitor Talzenna (talazoparib), a treatment for germline BRCA-mutant, HER2-negative breast cancer and homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer, brought in $27 million in revenues worldwide in Q4, a 22 percent increase from $22 million in the year-ago period.
Bosulif (bosutinib), a treatment for chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia, had global revenues of $171 million in the fourth quarter, a 6 percent drop compared to $182 million in Q4 2023.
Antibody-drug conjugate Tukysa for HER2-positive metastatic breast and colorectal cancer reported $129 million in Q4 revenues compared to $18 million for part of Q4 2023.
The firm also touted advancements in a study of its PD-L1-directed ADC, PF-08046054, which is currently being evaluated in a Phase I/II trial of PD-L1-expressing tumors, including non-small cell lung, head and neck, esophageal, ovarian, melanoma, and triple-negative breast cancer. Bourla added that the firm expects to begin two Phase III trials this year in first-line head and neck cancer and second-line or later NSCLC.
For the fourth quarter, Pfizer's reported net income was $410 million, or $.07 per share, compared to a net loss of $3.37 billion, or $.60 per share, in Q4 2023 due to the acquisition of Seagen. The firm's adjusted earnings per share was $.63 in the fourth quarter of 2024 compared to $.10 per share in the same period last year. On average, analysts were expecting an EPS of $.46 in Q4 2024.
Pfizer's full-year revenues for 2024 were $63.63 billion, a 7 percent increase from 2023 full-year revenues of $59.55 billion. Overall oncology revenues reported a 25 percent increase in 2024 to $15.62 billion from $12.45 billion in 2023.
Ibrance reported $4.37 billion in 2024 sales, an 8 percent drop compared to $4.75 billion in 2023. Lorbrena sales were up 36 percent in 2024 to $731 million versus $539 million in 2023. Combined Braftovi and Mektovi sales were $607 million in 2024 compared to $477 million in 2023, a 27 percent increase. Sales of Talzenna were $117 million in 2023, an 83 percent increase from 2023 sales of $64 million, and Bosulif sales remained flat at $645 million in 2024.
In its financial guidance for 2025, Pfizer expects full-year revenues between $61 billion and $64 billion and an adjusted EPS between $2.80 to $3.00.