GSK - VIIV HEALTHCARE INITIATES ROLLING SUBMISSION OF NEW DRUG APPLICATION WITH US FDA FOR LONG-ACTING CABOTEGRAVIR FOR PREVENTION OF HIV Source text: bit.ly/3tbvm8w
https://www.reuters.com/article/brief-gsk-says-viiv-healthcare-starts-ro-idUSFWN2MR0CZ
Older drugs, including Lipitor and Lyrica, weighed on Pfizer's (NYSE:PFE) growth in recent years. But investors hoped that things would improve significantly after the big drugmaker spun off its Upjohn unit. They also expected that Pfizer's COVID-19 vaccine, developed with BioNTech, would turbocharge growth. And now, investors' wishes have been fulfilled.
Pfizer announced its first-quarter results before the market opened on Tuesday. Despite a blowout quarter, the pharma stock slipped a little in early trading. Here are the highlights from Pfizer's Q1 update.
By the numbers
Pfizer reported revenue of $14.6 billion in the first quarter, a whopping 42% year-over-year jump. This result easily topped the average analyst revenue estimate of $13.6 billion.
The company announced Q1 net income of $4.9 billion, or $0.86 per share, based on generally accepted accounting principles (GAAP). In the prior-year period, Pfizer's GAAP earnings totaled $3.4 billion, or $0.60 per share.
Pfizer posted adjusted net income in the first quarter of $5.3 billion, or $0.93 per share. This marked a big improvement from adjusted earnings of $3.5 billion, or $0.63 per share, recorded in the prior-year period. It also was well above the consensus Wall Street estimate of $0.78 per share.
COVID-19 vaccine BNT162b2 was the star of Pfizer's first quarter. Sales for the vaccine totaled $3.46 billion, with a little over $2 billion of that amount generated in the U.S. Even without the COVID-19 vaccine, though, Pfizer's revenue increased 8% year over year. That improvement even includes a 5% negative impact from pricing.
Sales for the company's oncology drugs jumped 18% year over year to $2.86 billion. Prostate cancer drug Xtandi and kidney cancer drug Inlyta led the way, offsetting a 1% sales decline for breast cancer drug Ibrance.
Pfizer's internal-medicine drugs raked in $2.59 billion, up 11% year over year. Blood-thinner Eliquis especially stood out, with sales soaring 26% to $1.64 billion.
The drugmaker's hospital sales totaled $2.34 billion, a 12% increase. Although several drugs that Pfizer includes in the hospital category experienced sales declines, the company's global contract manufacturing and development organization (CDMO), Pfizer CentreOne, more than made up for those declines with strong revenue growth.
First-quarter inflammation and immunology sales rose 9% year over year to nearly $1.07 billion. Xeljanz was the big winner with 19% year-over-year sales growth.
Pfizer also recorded revenue of $824 million for its rare-disease drug lineup, a 29% jump. Nearly all of this increase was due to Vyndaqel, with the drug's sales nearly doubling year over year.
While Pfizer clearly delivered spectacular growth in the first quarter, there was an asterisk with its results. The company had three additional selling days in the U.S.and four extra selling days in international markets in the first quarter of 2021, compared to the prior-year period.
This is shaping up to be an outstanding year for Pfizer. The company raised its full-year 2021 guidance. It now expects sales of between $70.5 billion and $72.5 billion. Pfizer anticipates adjusted earnings per share of between $3.55 and $3.65.
The primary reason for this improved outlook is, unsurprisingly, BNT162b2. Pfizer now projects the COVID-19 vaccine will generate revenue of $26 billion this year, up from $15 billion in its previous quarterly update.
Next year is also looking pretty good for BNT162b2 sales. Pfizer already has contracts with Canada and Israel for beyond 2021. The company said that it's "currently negotiating similar potential contracts with multiple other countries." This includes the European Union, which appears to be close to finalizing a supply deal with Pfizer and BioNTech, for up to 1.8 billion doses to be delivered through 2023.
https://www.fool.com/investing/2021/05/04/pfizer-knocks-it-out-of-the-park-with-its-q1-resul/
- New preclinical data show that LY-CoV1404 binds and neutralizes all currently known circulating SARS-CoV-2 variants of concern
- LY-CoV1404 binds to a rarely mutated region of the SARS-CoV-2 spike protein, suggesting effectiveness against emerging variants
- LY-CoV1404 neutralizes authentic SARS-CoV-2 with high potency in vitro
- LY-CoV1404 enters clinical trials as part of Lilly’s BLAZE-4 study in patients with mild-to-moderate COVID-19 illness
https://finance.yahoo.com/news/abcellera-discovered-antibody-neutralizes-viral-103000927.html
Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. This donation furthers both Lilly and Direct Relief's charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together – providing options to treat COVID-19 patients at different stages of the disease.
Direct Relief will allocate donations of baricitinib to low- and lower-middle-income countries (based on World Bank classification) for the treatment of hospitalized COVID-19 patients requiring supplemental oxygen, based on requests from these governments to Direct Relief. Donations of bamlanivimab and etesevimab together will be provided by Direct Relief to those countries for the treatment of mild to moderate COVID-19 patients at high risk of progressing to hospitalization or death in the outpatient setting.
https://finance.yahoo.com/news/lilly-plans-donation-covid-19-140700286.html
Europe's medicines regulator said on Tuesday it has started a real-time review of Sinovac's COVID-19 vaccine, based on preliminary results from animal and human trials that suggested the vaccine produces an immune response against the coronavirus.
Data on the vaccine, COVID-19 Vaccine (Vero Cell) Inactivated, will be assessed as they are made available to help speed up potential approvals, the European Medicines Agency (EMA) said https://www.ema.europa.eu/en/news/ema-starts-rolling-review-covid-19-vaccine-vero-cell-inactivated.
This is the first Chinese vaccine the EMA is studying in real-time, and the fourth COVID-19 vaccine under such a review, including those from CureVac, Novavax Inc and Russia's Sputnik V.
Sinovac's vaccine has shown efficacy rates between 50% and 90% in different studies and is currently authorised for use in China, Indonesia, Brazil and Turkey.
The vaccine contains inactivated or dead versions of the SARS-CoV-2 virus to help the human body's immune system make antibodies.
In early April, Sinovac said its third production plant for its vaccine, branded CoronaVac in some regions, was ready, doubling its annual capacity to 2 billion doses. The firm said more than 200 million doses of Sinovac's vaccine have been delivered globally.
Rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is available.
NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, today announced that a peer-reviewed publication using the GeoMx® Digital Spatial Profiler (DSP) is to be published in the journal Nature. This paper describes using the GeoMx DSP to develop a foundational dataset to better understand the biological impact of SARS-CoV-2 (COVD-19) infection in human lungs, which may lead to the identification of new therapeutic interventions and prevention strategies.
Researchers from a network of institutions, including the Broad Institute and Beth Israel Deaconess Medical Center (BIDMC), Massachusetts General Hospital (MGH), the Ragon Institute of MGH, Massachusetts Institute of Technology (MIT), Harvard, Beth Israel Deaconess Medical Center, Brigham and Women’s Hospital, Columbia University Irving Medical Center, and scientists at NanoString used the GeoMx DSP to characterize autopsy lung tissue samples from patients who had been infected by the SARS-CoV-2 virus. In conjunction with single-cell RNA sequencing data collected for the project, researchers utilized the Cancer Transcriptome Atlas (CTA) and the Whole Transcriptome Atlas (WTA), with additional custom content specific for SARS-CoV-2 genes, to produce and spatially map a comprehensive cell-type atlas. The ability to pinpoint cellular processes, expression pathways, and immune cell profiles in this way offers key insights into systemic COVID-19 disease
The study, to be published in Nature and led by Aviv Regev, Ph.D., a computational biologist and executive vice president of Genentech Research and Early Development, and professor at the Broad Institute of MIT and Harvard and the Department of Biology of MIT, is entitled "COVID-19 tissue atlases reveal SARS-COV-2 pathology and cellular targets." [Broad Institute news release]
https://finance.yahoo.com/news/nanostring-digital-spatial-profiling-platform-070000616.html
