NEW YORK – Pfizer oncology revenues in the second quarter dropped 4 percent with sales declines across most of its targeted cancer drugs including Ibrance (palbociclib), Xalkori (crizotinib), Braftovi (encorafenib), and Mektovi (binimetinib).
Oncology revenues were $2.96 billion in Q2 versus $3.09 billion in Q2 2022. Total revenues for the three months ending June 30 were $12.73 billion, a 54 percent decline compared to $27.74 billion in the prior year's second quarter. The firm missed analysts' average revenue estimate of $13.27 billion for Q2.
Sales of Pfizer's top-selling oncology drug, CDK4/6 inhibitor Ibrance, fell 6 percent in Q2 to $1.25 billion from $1.32 billion in Q2 2022. The firm said the decline was due to competitive pressure, lower clinical trial purchases internationally, and planned price decreases in certain international markets.
Pfizer CSO Mikael Dolsten also discussed the future of the firm's hormone receptor (HR)-positive, HER2-negative breast cancer franchise on Tuesday during its Q2 conference call. The company is currently developing CDK4, CDK2, and KAT6 inhibitors for this breast cancer subpopulation that will expand its breast cancer portfolio. Ibrance is currently approved for advanced or metastatic HR-positive, HER2-negative breast cancer in the first line in combination with either an aromatase inhibitor or after disease progression in combination with fulvestrant.
In June, researchers presented data from a first-in-human Phase I/IIa trial of Pfizer's next-generation CDK4 inhibitor, PF-07220060, in advanced HR-positive, HER2-negative breast cancer patients who have received prior CDK4/6 inhibitor treatment. The response rate for the drug was 29 percent and median progression free survival was nearly 25 weeks. Dolsten noted that Pfizer is "actively planning" a Phase III randomized study of PF-07220060.
Dolsten also highlighted encouraging early data showing confirmed responses from Phase I trials of its CDK2 inhibitor and KAT6 inhibitor in heavily pretreated breast cancer.
"We are working to deliver the next wave of innovative therapies for estrogen receptor-positive breast cancer," Dolsten said. "Our clinical strategy entails first developing assets for the metastatic setting, in which Ibrance is currently the leader, followed by an opportunity to expand to earlier-stage breast cancer including the CDK4/6-naïve population and adjuvant or neoadjuvant settings."
The firm's first-generation ALK inhibitor Xalkori continued to report a decline in sales. In Q2, Xalkori generated $86 million in revenue versus $118 million in the prior year's second quarter, a 27 percent decrease. Meanwhile, its newer ALK inhibitor Lorbrena (lorlatinib), which is also approved for ALK-positive metastatic non-small cell lung cancer, generated $121 million in revenue, a 57 percent increase from Q2 2022 revenues of $77 million.
Pfizer's BRAF and MEK inhibitors for BRAF V600E-mutant colorectal cancer and melanoma, Braftovi and Mektovi, saw slight revenue declines in the second quarter. Braftovi revenues were $50 million in Q2 compared to $51 million in the year-ago period while Mektovi sales in Q2 were $43 million versus Q2 2022 sales of $44 million.
In the second half of the year, Pfizer expects a US approval to expand Braftovi and Mektovi's indication to include BRAF V600E-mutated metastatic non-small cell lung cancer. The firm filed a supplemental new drug application for the combination earlier this year.
In Q2, Pfizer also nabbed an expanded indication in the US for its PARP inhibitor Talzenna (talazoparib) plus hormone agent Xtandi (enzalutamide) for the treatment of metastatic castration-resistant prostate cancers harboring homologous recombination repair (HRR) deficiencies. Pfizer did not break out Q2 sales of Talzenna or Xtandi.
Pfizer CFO David Denton said on the call that the firm's $43 billion deal to acquire Seagen will help Pfizer refocus its efforts and investments on oncology. The firm is providing further information to regulatory agencies in the US and Europe to get the deal closed.
Pfizer narrowed its financial guidance for the remainder of the year due to uncertainty around sales of its COVID-19 products. The firm expects to bring in between $67 billion and $70 billion in revenues for full-year 2023. The firm's adjusted EPS is expected to be between $3.25 and $3.45, which is unchanged from its previous guidance.
Excluding COVID-19 products, Pfizer reduced its revenue growth expectations for 2023 to between 6 and 8 percent due to short-term headwinds. One of these headwinds includes the Talzenna/Xtandi approval in a biomarker-defined population of prostate cancer, where Pfizer initially hoped to gain an all-comer approval.
In Q2, Pfizer's R&D spending declined 6 percent to $2.65 billion compared to $2.82 billion in the prior year. The drugmaker spent $3.50 billion on selling, informational, and administrative expenses, up 15 percent from $3.05 billion in Q2 2022.
Pfizer's net income in Q2 2023 was $2.33 billion, or $.41 per share, compared to $9.91 billion, or $1.73 per share, in Q2 2022. The adjusted earnings per share were $.67, beating Wall Street analysts' average estimate of $.57 per share.