Note: All changes are versus the prior-year period unless otherwise stated
CEO Albert Bourla noted that Pfizer delivered "strong financial results in the first quarter," adding that "excluding the growth provided from [the COVID-19 vaccine] BNT162b2, our revenues grew 8% operationally." Meanwhile chief financial officer Frank D'Amelio said "I am very happy with the performance of all of our therapeutic areas this quarter," with "multiple innovative and biosimilar products across our portfolio deliver[ing] growth."
Pfizer now expects sales this year of between $70.5 billion and $72.5 billion, lifted from a prior range of $59.4 billion to $61.4 billion. Meanwhile, earnings per share are forecast to be between $3.55 and $3.65, boosted from previous guidance of $3.10 to $3.20. The company explained that the increased guidance primarily reflects higher anticipated sales of BNT162b2, which are now predicted to hit $26 billion, reflecting 1.6 billion doses to be delivered in 2021 under contracts signed as of mid-April, up from an earlier estimate of approximately $15 billion. Analysts predit sales this year of $61.6 billion on earnings of $3.21 per share.
"Based on what we've seen, we believe that a durable demand for our COVID-19 vaccine - similar to that of the flu vaccines - is a likely outcome," Bourla remarked. Pfizer, which developed BNT162b2 alongside BioNTech, indicated that it will have capacity to manufacture at least 3 billion doses of the vaccine in 2022, up from 2.5 billion doses this year. The drugmaker suggested that it will seek full FDA approval of BNT162b2 towards the end of this month, with an emergency-use authorisation filing for a booster dose expected to be submitted in July. It also expects to apply to the FDA in September for emergency authorisation to administer the vaccine to children between the ages of two and 11.
"There remain multiple moving parts to the Pfizer story right now, but we believe most of their core assets are performing well and are impressed by their success with the COVID-19 vaccine, which we think bodes well for improved (R&D) productivity and pipeline success to improve the company's 2026-30 outlook," Mizuho Securities analyst Vamil Divan noted.
Pfizer disclosed that enrolment has been halted in the registration-enabling Phase II MagnetisMM-3 study of elranatamab in patients with relapsed/refractory multiple myeloma in order to provide more information to the FDA. The company made the decision after three cases of peripheral neuropathy were observed in the ongoing Phase I MagnetisMM-1 trial of the investigational BCMA CD3-targeted bispecific antibody.
In addition, Pfizer said that it is working with the FDA to "address outstanding questions" related to its Duchenne muscular dystrophy gene therapy fordadistrogene movaparvovec, also known as PF06939926, in order to begin enrolling patients at US study sites in a Phase III trial. According to the company, the questions are related to its investigational new drug application, including technical aspects of its potency assay matrix.
"While we have high confidence in our current quality control overall and with the potency assay matrix, which has been accepted in countries outside the US, the FDA has additional technical requests that we are working to address as quickly as possible," Pfizer said. The drugmaker noted that it does "not expect resolution in 1H 2021," but will continue to recruit patients at other global sites.
Other programmes that were discontinued by Pfizer in the first-quarter can be seen below:
To read more Top Story articles, click here.