Pfizer’s Early Metsera Data Leaves Analysts Wanting More

 

Analysts parsed the limited data available for Pfizer’s obesity candidate on the pharma’s fourth-quarter earnings call Tuesday, looking for any nugget of additional context.

A small dab of data for Pfizer’s Metsera-acquired obesity asset PF’3944 has provided the pharma what it needs to confidently launch a Phase III trial later this year, executives said. But analysts were far from sated after the limited release of information on Tuesday.

Prior to the earnings call this morning, Pfizer revealed that the newly named PF’3944—formerly MET-097i—achieved 12.3% weight loss in the Phase IIb VESPER-3 trial at week 28. The results come from the 4.8-mg and 3.2-mg dose arms, each of which involved monthly treatments. BMO Capital Markets called the data “competitive” in a note following the data release.

But feeding off a tidbit from Pfizer management—and repeated by Chief Scientific Officer Chris Boshoff on the Tuesday morning earnings call—Leerink Partners began to wonder later if the VESPER-3 results were less competitive than initially thought. The readout did not provide specific numbers for the placebo arm, though Boshoff stated on the call that that group’s weight was “stable.”

Assuming no weight gain or loss in the placebo patients means that on a placebo-adjusted basis—which has become the gold standard for analyst comparisons of different weight loss candidates—the absolute weight loss is around 12%, Leerink said Tuesday in a note delivered during the earnings call. Compare that to Eli Lilly’s Zepbound, which achieved 16% absolute weight loss at week 28.

Leerink also figures that VESPER-3 had a discontinuation rate of about 10%, which is higher than Zepbound’s 6%, although the latter study had hundreds more patients.

Analyst speculation aside, Boshoff said the study met its two main objectives: to show continued weight loss when switching from a weekly to a monthly dosing schedule and a positive safety and tolerability profile.

“For the first time, we have shown that GLP-1 receptor agonist peptides can be administered monthly, while maintaining the potential for competitive efficacy and sale,” CEO Albert Bourla added.

With the results for the lower doses in hand, Pfizer is now ready to move into Phase III with the highest 9.6-mg dose. That dose is already being studied in a trial that splits the amount into individual 2.4-mg doses for weekly administration, Boshoff explained.

While Pfizer does not yet have results for the 9.6-mg dose, the company is predicting weight loss of around 15.8%. Analysts and investors will have to wait until June when more details from the VESPER-3 study are revealed at the American Diabetes Association conference.

Missing Details

Boshoff declined to expand on the placebo group results, the demographics of trial participants or the duration of gastrointestinal adverse side effects. He did say that the study was conducted in the U.S. and that Pfizer is generally happy with the safety profile. The study revealed one severe case of nausea and no severe cases of diarrhea.

Pfizer has a robust clinical program planned for PF’3944, with two Phase III studies expected to start this year in patients who are overweight or have obesity. Another seven trials will dig into the drug’s effect on comorbidities of obesity and other ways to improve patient access and optionality.

When asked if PF’3944 could potentially be dosed even further apart than monthly, Boshoff said it’s possible—but Pfizer has yet to test that. The company is advancing a different molecule, a Phase I pro-drug peptide, that could be dosed as far apart as every three months, the chief scientist explained.

All told, Pfizer has 10 Phase III trials that will advance this year across its obesity portfolio, including in-house assets and those acquired via Metsera.

Chief Commercial Officer Aamir Malik insisted that the weight loss market has plenty of room for new players, particularly with higher weight loss, more convenient dosing or improved tolerability.

“What you need to win in a market like that is, one, you need a great portfolio of products that can serve all those patient needs. And two, you need really differentiated capabilities,” Malik said. “We have a lot of confidence in our ability to win commercially in this market with these assets.”

PF’3944 specifically is being aimed as a monthly maintenance therapy. Bourla said that Pfizer intends to test switching strategies for patients taking other GLP-1s in future studies.

A Mild Year for COVID

The VESPER-3 readout was by far the highlight of the conference call but Pfizer also reported what multiple analyst firms called “a solid quarter” with sales of $17.56 billion, beating the firm’s estimate of $16.79 billion, according to a Tuesday morning note.

“Commercially Pfizer printed another solid quarter, beating on both the top and bottom line supported across all three key pillars of the company,” BMO Capital Markets wrote in a Tuesday morning note.

The beat was driven by sales of Pfizer’s vaccine portfolio, including Comirnaty (COVID-19), Abrysvo (respiratory syncytial virus, RSV) and Prevnar (pneumococcal), while COVID-19 treatment Paxlovid was “notably light,” according to Guggenheim. BMO said Paxlovid fell 54% below consensus, with sales of $218 million for the quarter—a 70% drop from the same period a year earlier when sales were $727 million.

Bourla was nevertheless pleased with the COVID-19 franchise’s performance, given this year’s viral strain proved to be the least severe so far.

Pfizer reiterated previous guidance, with sales expected to be in the range of $59.5 billion to $62.5 billion for 2026.

CFO Dave Denton also noted that Pfizer’s previously stated $6 billion capacity for business development has actually gone up slightly, although he did not provide specific numbers.

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