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Pfizer expects $1B hit from IRA's Part D redesign and no major M&A in 2025
  • Publisher:Phexcom
  • Publication:2024/12/5

After pulling off a surprise third-quarter beat and full-year guidance raise amid shareholder activism earlier this year, Pfizer now expects its 2025 revenues to come in the same range as in 2024.

Pfizer on Tuesday confirmed its projection of achieving $61 billion to $64 billion in 2024 revenue. The company also shared its outlook for 2025, providing a revenue forecast with the exact same range.

But the makeup of Pfizer’s 2025 revenues won’t be the same, executives explained on an investor call.

While Pfizer expects revenues from its COVID-19 products—vaccine Comirnaty and antiviral Paxlovid—to be largely consistent with 2024, the 2025 projection excludes about $1.2 billion of one-time revenues that Paxlovid earned this year. Examples of such non-recurring revenues include contracts with the U.S. Strategic National Stockpile, which contributed $442 million to Pfizer’s third-quarter revenue.

The market utilization of Comirnaty and Paxlovid has been “following identical patterns,” and the uncertainties in 2024 were related to one-time events, Pfizer CEO Albert Bourla noted during an investor call Tuesday.

With President-elect Donald Trump’s selection of Robert F. Kennedy Jr. as the next secretary of the Department of Health and Human Services, fears have grown that access to life-saving vaccines could be restricted given Kennedy’s past anti-vaccine stance.

Pfizer assumes that there will be no material U.S. vaccines policy changes in 2025, the company’s CFO, Dave Denton, said on the call.

“But of course, we are very alerted, and that’s why we have these very productive discussions with the incoming Trump administration to ensure that the health and safety of the people that are using our products is there,” Bourla said.

One major policy shift that will take effect in 2025 is a complete redesign of the Medicare Part D benefit design under the Inflation Reduction Act. Starting in 2025, a lower $2,000 cap on out-of-pocket drug spending will be in place for Part D enrollees. Drugmakers will also pay a larger share of cost for catastrophic coverage, with a required 20% discount on branded drugs.

By Pfizer’s estimate, the new out of pocket cap will lead to higher utilization of its drugs and an additional $500 million in revenues in 2025, only to be offset by a $1.5 billion headwind thanks to the extra costs it must bear in the catastrophic coverage phase, Denton explained. The net $1 billion negative impact will represent a 1.6% pull on Pfizer’s topline revenue next year. The CFO declined to give a product breakdown for the calculation.

Because of the IRA policy change and new competition, Pfizer expects growth of its blockbuster heart disease med Vyndaqel will be “tempered,” Denton said.

The Vyndaqel family of drugs for the treatment of transthyretin amyloid cardiomyopathy is Pfizer’s fourth top-selling product, generating $3.9 billion in sales in the first nine months of 2024. The FDA in November approved BridgeBio’s rival drug Attruby and is slated to make a decision on Alnylam’s Amvuttra in the indication in March of 2025.

As sales from the COVID products fell from a pandemic high, Pfizer launched several rounds of cost cuts beginning in the fall of 2023. The company achieved $4 billion in net cost savings through 2024 and now anticipates an additional $500 million in savings in 2025 as part of the ongoing restructuring.

In 2025, Pfizer expects its adjusted diluted earnings per share will come in a range of $2.8 to $3, reflecting an operational increase of 10% to 18% year over year after excluding some one-time items.

Buoyed by the COVID revenue windfall, Pfizer previously went on a dealmaking spree, signing large acquisitions including the $43 billion buyout of Seagen. In 2025, Pfizer does not plan to do large business development transactions, which is “largely a [20]26-and-beyond focus for us,” Denton said.

“Having said that, as I’ve always stated, we always have a little flexibility to do BD in the near term as we see appropriate assets that would enhance our value long term,” he added.