Ponsegromab

Pfizer’s high-profile, high-volatility Covid-19 franchise stabilized at the end of 2024, as the New York drugmaker pursues a revamp of its R&D operations and continues to cut costs. Pfizer’s Covid pill Paxlovid and its vaccine, Comirnaty, both hit their sales goals for 2024, totaling more than $11 billion in combined sales, the company reported Tuesday . It also reported overall revenue of $63.6 billion for the year, close to the top end of its guidance. CEO Albert Bourla said in prepared remarks that after a year of focusing on costs and resetting its commercial operations, the focus in 2025 “will move to improving R&D productivity.” The company also stuck by its 2025 forecasts issued in December. Pfizer’s R&D work is certain to get extra scrutiny as new chief scientific officer Chris Boshoff continues to make changes. He’s already begun reorganizing the R&D operations, splitting them into independent groups focused on four areas: oncology, vaccines, internal medicine, and immunology and inflammation. That has included some cuts. The company formally culled a late-stage RSV treatment, which Endpoints News first reported in early October, and dropped the pursuit of a second indication for its cachexia drug ponsegromab in heart failure. The heart failure readout was previously delayed from 2025 to 2026. Pfizer also took a $1 billion write-down on a B7H4-directed antibody-drug conjugate acquired in the Seagen purchase. Another $200 million impairment charge was associated with a HER-2-targeting ADC from Seagen, “reflecting emerging competition,” Pfizer noted. Adjusted R&D expenses for the quarter were slightly under $3 billion, 22% below analysts’ consensus. In prepared remarks, CFO Dave Denton attributed that to lower spending on some vaccine programs and “and as a result of our cost realignment program.” When Pfizer announced 2025 guidance, it tacked on $500 million in additional restructuring savings, bringing the total to $4.5 billion. Another $1.5 billion in savings is expected by the end of 2027, after the first phase of a manufacturing overhaul is complete. Fourth-quarter revenue looked significantly better than for 2023, when Pfizer took a one-time, $3.5 billion revenue reversal on Paxlovid related to end-of-the-pandemic product returns by the US government. Paxlovid sales were $727 million in the quarter. The pharma’s RSV vaccine Abrysvo struggled, as has been the case for fellow developers in the vaccines’ second season. Sales were down 62% compared to the fourth quarter of 2023, Pfizer reported. Editor’s note: This story was updated throughout with additional details from Pfizer’s earnings.

hapabapa/Getty Images CEO Albert Bourla, who is under attack from activist investor Starboard Value, got a much-needed victory on Tuesday as Pfizer reported that third-quarter revenue and adjusted profit beat the analysts’ consensus. With a $1 billion stake in Pfizer, activist investor Starboard Value has recently criticized CEO Albert Bourla and senior management for “dramatically” underperforming peers and the market. However, the company on Tuesday reported its third consecutive quarter of positive results , handily beating Wall Street’s expectations. In Q3, Pfizer secured revenue of $17.7 billion compared to the consensus estimate of $14.92 billion, while reporting earnings per share of $1.06 that topped the analyst estimate of $0.62. COVID-10 antiviral medication Paxlovid brought in $2.7 billion in the quarter, up from the $202 million that Pfizer posted in Q3 2023. Guggenheim analyst Vamil Divan in a note to investors called Pfizer’s Q3 performance “very strong” and highlighted Paxlovid sales, “which beat our increased expectations by over $1B and consensus by more than $2B.” BMO Capital Markets analyst Evan Seigerman called Tuesday’s financial results a “solid” Q3 for Pfizer with a top- and bottom-line beat. The quarterly win comes at a critical time for Pfizer’s CEO, who is under pressure from Starboard Value. Analysts in recent weeks have rallied around Bourla in response to the Starboard challenge. However, Guggenheim’s Divan on Tuesday warned that “investors will continue to look for more visibility into how management hopes to navigate the various challenges they face in the coming years as many of their top products either lose patent protection or face increased competition.” Looking ahead, Pfizer on Tuesday raised its full-year 2024 revenue outlook to between $61 billion and $64 billion, up from a previous range of $59.5 billion to $62.5 billion. The company also raised its guidance on adjusted annual earnings per share to a range of $2.75 to $2.95 per share, an increase from a previous range of $2.45 to $2.65 per share. Leerink analyst David Risinger in a note to investors said Pfizer’s new guidance ranges imply a “conservative” Q4. Assuming the company achieves the high end of its new guidances, Risinger contends revenue for the final quarter of 2024 would be $17.3 billion, which is 4% below current consensus of $18.1 billion. Risinger in a separate note said that “likely in response to activist investor Starboard engagement,” Pfizer plans to showcase the company’s pipeline on Nov. 1, starting with ponsegromab—a monoclonal antibody directed against growth differentiation factor-15 (GDF-15), which showed positive results in a Phase II study in patients with cancer cachexia and elevated levels of GDF-15. The candidate is also being investigated in a Phase II study in patients with heart failure and elevated serum GDF-15 concentrations. “We learned from a clinicaltrials.gov update that Pfizer recently upsized and delayed ponsegromab’s Ph2 trial, including changing the estimated primary completion date from March 2025 to March 2026,” according to Risinger. While he awaits management comments on the rationale behind the heart failure trial changes, Risinger continues to view ponsegromab as having “multi-billion-dollar blockbuster potential in cancer cachexia due to lack of approved therapies plus potentially other indications.”