NEW YORK – Pfizer on Tuesday reported that despite a 2 percent growth in overall fourth quarter revenues, oncology division drug sales declined 7 percent compared to Q4 2021, partly due to lower revenue from certain precision oncology drugs.
Overall revenues were $24.29 billion for the three months ended Dec. 31, compared to $23.84 billion during the same period in 2021, and in line with analysts' average revenue expectations for the quarter. Revenues from the oncology division totaled $3.01 billion during the quarter compared to $3.24 billion in the year-ago quarter.
Sales of Pfizer's top-selling cancer drug, the CDK4/6 inhibitor Ibrance (palbociclib), were $1.28 billion in Q4 2022, an 8 percent drop from $1.40 billion in Q4 2021. US sales of the drug remained flat in Q4 at around $876 million while international sales fell 22 percent to $403 million from $519 million in Q4 2021.
Angela Hwang, chief commercial officer at Pfizer, said on a call to discuss the financial results that the international decline in Ibrance revenues was due to changes in reimbursement in Europe. The overall decline was also driven by more patients using Pfizer's patient assistance program to access Ibrance in the US.
However, Pfizer is hoping to advance its pipeline of "complimentary" CDK inhibitors in 2023, Pfizer CSO Mikael Dolsten said. In the first half of 2023, the company expects to report data from a Phase I trial of its CDK4 inhibitor, PF-07220060, in hormone receptor (HR)-positive, HER2-negative metastatic breast cancer. "Our CDK4 inhibitor targets improving on the current CDK4/6 inhibition standard of care by maximizing CDK4 coverage," Dolsten said. "The majority of hormone receptor-positive breast cancers express low CD6, while CDK4 is likely to be a major cell cycle driver."
Dolsten noted that among 21 evaluable patients who received the CDK4 inhibitor PF-07220060 with endocrine therapy in the Phase I trial, the objective response rate was nearly 30 percent and the median progression-free survival was 24.7 weeks by investigator assessment.
"We are currently engaged in dose optimization and enrolling a CDK4/6-naïve cohort," Dolsten said. "We're planning to start the randomized study [of the CDK4 inhibitor] in second-line treatment of estrogen receptor-positive, HER2-negative metastatic breast cancer this year."
Pfizer expects to advance other breast cancer programs this year. The company expects to begin a pivotal Phase III study of ARV-471, an estrogen receptor degrader it is codeveloping with Arvinas, in ER-positive, HER2-negative breast cancer. The company is also anticipating a data readout from a Phase II study of its KAT6 inhibitor, PF-07248144, in ER-positive, HER2-negative breast cancer.
Revenues from Pfizer's first-generation ALK inhibitor Xalkori (crizotinib) for non-small cell lung cancer declined 16 percent to $103 million in the quarter from $122 million in Q4 2021. However, the firm's second-generation ALK inhibitor Lorbrena (lorlatinib) reported $95 million in global revenue during the fourth quarter, a 30 percent increase compared to Q4 2021, when it netted $73 million.
The company's BRAF-MEK inhibitor combination for BRAF-mutant colorectal cancer had mixed results in Q4 2022. The BRAF inhibitor Braftovi (encorafenib) reported $37 million in sales, down 26 percent from $51 million in the year-ago quarter, while revenues from the MEK inhibitor Mektovi (binimetinib) increased 9 percent to $46 million from $42 million in Q4 2021.
In its hematology portfolio, Pfizer is expecting a data readout this year from a Phase II study of TTI-622, a CD47 inhibitor the firm obtained with the acquisition of Trillium Therapeutics in 2021. That study will involve patients with large B-cell lymphomas harboring certain mutations.
In Q4, Pfizer's R&D expenses increased 5 percent to $3.62 billion from $3.45 billion in Q4 2021. The company also spent $4.64 billion on selling, informational, and administrative expenses, a 13 percent increase from $4.10 billion spent in Q4 2021.
Pfizer's net income in Q4 2022 was around $5.0 billion, or $.87 per share, compared to $3.39 billion, or $.59 per share, in Q4 2021. The company's adjusted diluted earnings per share was $1.14; the consensus Wall Street estimate was $1.05 per share.
Full-year 2022 revenues were $100.33 billion, a 23 percent increase from $81.29 billion in 2021, slightly exceeding analysts' consensus expectations of $100.27 billion. Oncology revenues, meanwhile, decreased 2 percent during the same period to $12.13 billion from $12.33 billion.
Pfizer recorded a net income of $31.37 billion, or $5.47 per share, in 2022, compared to $21.98 billion, or $3.85 per share, in 2021. The company's adjusted diluted EPS was $6.58; analysts on average had projected an EPS of $6.49.
R&D expenditures grew 10 percent during the year to $11.43 billion from $10.36 billion in 2021. During the same period SI&A expenses grew 11 percent to $13.68 billion from $12.70 billion.
Pfizer is expecting between $67 billion and $71 billion in revenues in 2023, and adjusted diluted EPS in the range of $3.25 to $3.45. Excluding sales from COVID-19 products, which are expected to decline this year, Pfizer expects 2023 revenues to grow between 7 percent and 9 percent.