With a bold prediction that interim data on its COVID-19 shot would be in the public's hands by October, all eyes have been on Pfizer and CEO Albert Bourla. But with just days to go before November, those data still aren't available—and Pfizer is holding on to hope that it can still roll out the shot by year-end.
Pfizer could still ship its mRNA-based COVID-19 shot to U.S. patients this year even if it misses its ambitious readout plans, CEO Albert Bourla told analysts on a third-quarter earnings call Tuesday.
To launch, Pfizer and partner BioNTech need the FDA's emergency use authorization after snagging a data committee's interim analysis and culling safety data on the shot, Bourla said. Pfizer had set a date for its FDA submission in the third week of November—but there's plenty of reason to worry whether it will hit that schedule.
"It is up to FDA to take as much time as they need to make an approval," Bourla said. "What I know is we will be ready with product available to distribute an initial number of doses."
With the end of October looming, a data committee for the phase 3 study of Pfizer's shot has yet to receive unblinded interim data because of a lower-than-expected number of severe events—in this case, COVID-19 infections or re-infections—reported so far among trial participants.
Bourla said it would take "between five and seven days" for an interim analysis to be completed once those data are unblinded, likely putting a readout into the first week of November at the earliest.
During the call, analysts targeted Bourla's previous forecast that Pfizer's vaccine would deliver interim phase 3 data by October. One called that forecast "bullish." Bourla pushed back against that characterization and asked for the general public's patience as the drugmaker works toward a readout.
"I’m not bullish that a vaccine will work—what I said very clearly is we want to know by the end of October whether it works or not," Bourla said.
Whether "bullish" or not, Bourla has previously been more than willing to set public expectations on his company's vaccine work, telling The Washington Post in September that "the truth will be revealed" this month.
Amid Pfizer's push to get its COVID-19 vaccine on the market as soon as possible, the drugmaker is also working on a long-awaited spinoff of its Upjohn generics unit, which continued to torpedo revenues in the third quarter.
Pfizer's biopharma business posted 4% growth in the third quarter at $12.1 billion—but that was without Upjohn, where sales fell 18% thanks to Chinese procurement competition and falling sales in Japan and elsewhere. Together, the two businesses delivered a 4% decline. Pfizer is hoping to close the unit's spinoff and merger with Mylan in the fourth quarter despite delays tied to COVID-19.
With Upjohn off the books, a smaller and tighter Pfizer is holding to its predictions of 6% growth through 2025 on the back of a bustling branded portfolio that won't see a major patent cliff until 2026. Pfizer is also expecting a big influx of cash in the coming years, which could serve as a war chest for late-stage pipeline pickups, Bourla said.
"We generate a lot of cash, and we want to invest this cash," Bourla said.
With that in mind, Chief Financial Officer Frank D'Amelio said Pfizer's open to all kinds of deal-making. "On M&A, we say never say never," D'Amelio said. "I wouldn’t put a cap on what we can spend given the firepower we have."