During an earnings call for the company’s third quarter results, Pfizer’s chief executive officer Albert Bourla said a data monitoring committee has not yet conducted any interim efficacy analysis of the company’s potential COVID-19 shot.
Previously, Pfizer and its partner BioNTech had planned to seek regulatory approval for the COVID-19 vaccine, BNT162b2, this month.
However, in an open letter published last week, Bourla said that the companies will not submit the vaccine for emergency use authorisation in the US until the third week of November.
In an earnings call yesterday, Bourla reiterated this timeline, adding that “in [the] case of a conclusive readout, positive or negative, we will inform the public as soon as we complete the necessary administrative work, which we estimate to be completed within one week from the time we know”.
“We may know whether or not the vaccine demonstrates efficacy soon,” he added.
Aside from details about the timelines for the COVID-19 vaccine, Pfizer’s third quarter earnings report showed a slip in earnings to $12.13bn, a decrease of 4% from last year. According to The Motley Fool, this figure missed the average analyst expectation of $12.33bn.
Net income also dropped significantly in the third quarter of 2020, with Pfizer reporting $2.19bn in the most current quarter compared to a net income of $7.7bn for the same period last year.
Revenues from its generics business Upjohn also dropped by 18% operationally to $1.91bn compared to $2.35bn in the third quarter last year.
This was driven by competition for epilepsy drug Lyrica (pregabalin) in the US, as well as lower revenue for key drugs in China due to the impact from the country’s new volume-based procurement programme.
The negative impact of COVID-19 on Pfizer’s earnings represented approximately $500m, the company added.
This was primarily due to lower demand for certain products in China, as well as disruptions to doctor visits in the US which negatively impacted prescribing patterns for some of its drugs.
One bright spot was an increase in revenues for Pfizer’s biopharma business, which climbed 4% to $10.2bn in the third quarter.
This increase was helped by a 125% increase in global revenues for its rare disease med Vyndaqel (tafamidis), totalling $351m.
Global revenues for its biosimilar also reach $424m, up 80% operationally, driven mostly by recent oncology launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) in the US and other global markets.
Pfizer has now tightened its full-year revenue guidance to a range of $48.8bn to $49.5bn from a previously reported outlook of between $48.6bn to $50.6bn.