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Pfizer Inc. expects global demand for vaccines against coronavirus diseases to last at least several years, sharpening a long-term prognosis for its experimental Covid-19 vaccine as the company progresses to the final stage of clinical trials.
Mass vaccines worldwide may be required by 2022, and booster vaccines may be required annually or every few years if the new coronavirus becomes a seasonal or long-term health problem, company executives said Tuesday.
Chief Executive Albert Bourla criticized executive orders signed last week by President Trump aiming to reduce drug prices in the United States, saying such policies risk detracting from the effort to develop Covid drugs -19 at a critical time.
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“They represent a huge distraction at a time when the industry needs to be fully focused on developing potential Covid vaccines or treatments,” Bourla said in a conference call after Pfizer reported second quarter financial results.
New York-based Pfizer reported an 11% decrease in revenue from the previous year to $ 11.8 billion, but the earnings exceeded analyst expectations and the company said its manufacturing operations have faced few disruptions from Covid. -19.
The possibility of a long-term demand for a Covid-19 vaccine offers a potential growth opportunity as the company plans to invest more than $ 1 billion this year to develop the vaccine. While the drug maker already makes the best-selling pneumococcal vaccine Prevnar 13, it has been expanding its manufacturing capabilities around the world in anticipation of a safe and effective vaccine.
“Coronaviruses tend to be adept at evading sustained immunity,” said head of research and development Dr. Mikael Dolsten in an interview. Dr. Dolsten said the virus class has been “adapted to circulate in humans and cross many species, so it would be unlikely that it would simply begin to disappear.”
Angela Hwang, president of the Pfizer Biopharmaceuticals Group, told investors in a conference call that the company anticipates standard or seasonal vaccines for several years beyond 2022.
Analysts at JPMorgan Chase & Co. estimate Pfizer’s vaccine-generating annual sales will reach around $ 5.5 billion in 2022, assuming a starting price of about $ 20 per dose in the US.
Pfizer began the latest stage, or phase 3, of an experimental Covid-19 vaccine study Monday that seeks to enroll 30,000 people. Pfizer is developing the vaccine, one of the most advanced for the new coronavirus, with BioNTech SE. Another major vaccine developer, Moderna Inc., started its own phase 3 study this week. A vaccine developed by researchers from the University of Oxford and AstraZeneca PLC that has started late-stage testing abroad is slated to begin final phase 3 studies in the United States next month.
The Pfizer study is advancing rapidly and points to October to request regulatory approval or emergency use authorization. The company aims to quickly determine the vaccine’s efficacy in part through tests in areas of the US where the virus is spreading and enrolling a diverse population, including high-risk participants.
The vaccine you are giving to test patients is different from the one the companies previously published scientific results. Pfizer said the latest vaccine appears to be more tolerable and could provide better protection against Covid-19.
Bourla said Tuesday that the company will no longer charge developed countries outside the US for the potential Covid-19 vaccine, if proven to work safely, than it would charge in developing countries in the US. The US, like those in Africa, or governments that cannot afford the vaccine could pay less, Bourla said in the interview.
“It is a very different dynamic there and I am not going to maintain the same standard to charge $ 19 per dose,” he said of African countries.
Prices and costs have emerged as increasingly delicate problems for vaccine manufacturers and the governments that pay for them. Some companies have said they will charge a price for the cost of producing their shots. Last week, the United States agreed to pay Pfizer and partner BioNTech nearly $ 2 billion to insure 100 million doses, which analysts estimated at about $ 20 per dose. It also agreed to supply the United Kingdom with 30 million doses for an unspecified amount.
Pfizer’s price could change after the pandemic phase, when the vaccines would be affected by typical trade factors such as competition and volume, Bourla said in the investors’ call.
The vaccine the company is testing uses an unproven gene-based technology known as messenger RNA, or mRNA that is involved in making a spike-shaped protein that resembles that on the surface of the coronavirus. The vaccine candidate used in the final phase 3 study encodes a full-size peak protein, rather than just part of it, as used in the previous candidate. Pfizer researchers believe this vaccine would offer better protection, especially for older adults.
Mark Mulligan, director of the NYU Langone Health Vaccine Center, which began administering doses of the Pfizer vaccine on Tuesday, said his goal is to enroll hundreds of subjects in about two months. The company will begin by reviewing the more than 1,000 people who expressed interest in Pfizer’s early-stage trial, looking for “those at higher-than-average risk,” said Dr. Mulligan. “We really have to enroll the right people.”
Separately, the company also said it expects to start testing its experimental antiviral for Covid-19 in humans in September.
Pfizer reported revenue of $ 11.8 billion on Tuesday, an 11% decrease from $ 13.3 billion from the previous year. Analyst consensus had forecast sales of $ 11.58 billion, according to FactSet. The company reported growth in its biopharmacy division in the last quarter, but overall sales fell amid increased competition in its generic drug business.
The pandemic caused quarterly sales to drop approximately 4%, in part due to interruptions in wellness visits for adults and children. Sales of Pfizer’s division of newer, patent-protected drugs, which includes Ibrance breast cancer treatment and the blood thinner Eliquis, grew 4% to $ 9.8 billion, up from $ 9.43 billion a year previous.
But the company’s overall sales trend was slowed by falling sales at Upjohn, Pfizer’s non-patent medicine division. Upjohn’s sales decreased 32% year-over-year to around $ 2 billion, which the company attributed in part to the loss of exclusivity of its pain medication Lyrica. Pfizer agreed last year to combine Upjohn with Mylan NV. The deal, which would create a company called Viatris, is expected to close in the fourth quarter.
Pfizer’s quarterly profit was 61 cents per share, or 78 cents per adjusted share, the company said. Analysts had forecast an adjusted earnings of 67 cents a share.
The company also slightly increased its full-year earnings guidance as it will exist after the Upjohn transaction, raising its projected sales range to $ 40.8 billion to $ 42.4 billion. Previously, Pfizer had guided annual revenue from $ 40.7 billion to $ 42.3 billion. The guide does not take into account future sales of Covid-19 vaccines.
Write to Matt Grossman at [email protected]
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