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Chicago, IL – February 14, 2022 – Zacks.com announces the list of stocks featured in the analyst blog. Every day, Zacks Equity Research analysts discuss the latest news and events impacting stocks and financial markets. Stocks recently featured in the blog include: Pfizer PFE, AstraZeneca AZN, Glaxo GSK, Sanofi’s SNY and Eli Lilly LLY.
Here are highlights from Friday’s analyst blog:
Pharmaceutical stocks roundup: Q4 earnings release
This week, Pfizer, Astra Zeneca andGlaxo announced its fourth quarter and full year 2021 results. While the FDA approved SanofiNew drug for rare blood disorders, Enjaymo, an FDA advisory committee, voted that Eli Lily and partner Innovent Biologics are conducting an additional study to gain approval for their lung cancer candidate, sintilimab, in the United States.
Recap of the most important stories of the week
Income update:Pfizer’s fourth-quarter results were mixed as it beat estimates for profit but missed the same for sales. Revenue from direct sales and the alliance of it and its BioNTech partner Comirnaty’s COVID-19 vaccine was $12.5 billion in the quarter,
Pfizer has released its financial guidance for 2022. Revenue is expected to be between $98.0 billion and $102.0 billion. The revenue forecast includes about $32.0 billion in sales from Comirnaty and $22 billion from a promising new oral antiviral pill for COVID-19, Paxlovid. Adjusted earnings per share are expected to be in the range of $6.35 to $6.55. Its sales forecast for 2022 was below market expectations.
Glaxo beat estimates for profit and sales. While Pharmaceuticals sales increased 25% at CER, Consumer Healthcare segment sales increased 10%. Vaccine sales were down 7% at CER due to lower revenue from the majority of its vaccines, including Shingrix. Glaxo has announced its earnings growth forecast for the year for the new company that will be created after the Consumer Healthcare business is spun off. The company expects sales of the new Glaxo to increase by 5% to 7% in 2022
AstraZeneca’s fourth quarter results were strong as they beat estimates for profit and sales. Product sales growth was driven by its COVID-19 vaccine and higher sales of new drugs in oncology and CVRM units such as Tagrisso and Farxiga, which offset some negative impacts from the pandemic and slower sales growth in China. Rare disease drugs added following the acquisition of Alexion also contributed to the sales growth.
AstraZeneca has also released encouraging forecasts for 2022. It expects total revenue to increase as a percentage of teens in 2022.
FDA approves Sanofi’s new rare blood disorder drug: The FDA has granted approval to Sanofi’s Enjaymo (sutimlimab-jome) for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD), a rare blood disorder. Enjaymo is now the first and only FDA-approved therapy for the treatment of patients with coronary artery disease. Regulatory applications for sutimlimab approval in Europe and Japan are currently under review.
In November of last year, the FDA issued a Complete Response Letter (CRL) to the Biologics License Application (BLA) for sutimlimab due to certain deficiencies identified by the FDA during a pre-shipment inspection. the license of a third-party manufacturing facility. Finally, the FDA accepted the new BLA submission for sutimlimab in October 2021.
The FDA has accepted and granted priority review to Sanofi’s Supplemental Biologics License Application (sBLA) seeking approval of its lead drug Dupixent for the treatment of moderate to severe atopic dermatitis in children aged 6 months to 5 years. The FDA decision is expected on June 9, 2022. Currently, Dupixent is approved to treat moderate to severe atopic dermatitis in patients 6 years of age and older.
FDA panel votes against approval of Lilly’s Sintilimab BLA:The FDA’s Oncology Drug Advisory Committee voted 14 to 0 for Lilly and partner Innovent Biologics to conduct an additional trial to seek approval for their lung cancer candidate, sintilimab
Lilly/Innovent markets sintilimab under the trade name Tyvyt only in China. Lilly is seeking approval for sintilimab in the United States for the first-line treatment of adult patients with advanced non-squamous non-small cell lung cancer (NSCLC).
The ODAC committee’s negative vote stems from the fact that the BLA for sintilimab, which was submitted by Innovent, was based on a study, ORIENT-11, conducted exclusively in China. The committee argued that the study data is not applicable to the US population and US medical practice. It is difficult to draw a definitive conclusion whether the pharmacokinetic (PK) data can be applied to the diverse US population.
The committee therefore recommended further study to demonstrate applicability to the US population before the BLA could be approved. Lilly and Innovent expressed disappointment with the ODAC outcome and will work with the FDA to complete the review of the sintilimab application.
Lilly also announced an agreement to supply the U.S. government with up to 600,000 doses of its experimental COVID drug, bebtelovimab, for at least $720 million, if urgently approved by the FDA. Lilly has filed an emergency approval request for bebtelovimab for mild to moderate COVID-19.
In January, the FDA revised the emergency use authorization (EUA) for Lilly’s already approved antibody cocktail drug for COVID-19, bamlanivimab plus etesevimab, limiting their use in patients who have been infected or exposed to a variant of coronavirus sensitive to these treatments.
The FDA’s decision to limit the authorized use of bamlanivimab/etesevimab was based on data that showed these treatment options are highly unlikely to be effective against the Omicron variant in the United States. However, Lilly said authentic viral analysis of bebtelovimab demonstrated that bebtelovimab neutralizes all known variants of concern, including Omicron.
The NYSE ARCA Pharmaceutical Index is down 0.9% over the past five trading sessions.
Over the past five trading sessions, AbbVie rose the most (2.2%) while Pfizer fell the most (5.2%).
Over the past six months, AbbVie has seen the maximum gain (26.2%) while Lilly has fallen the most (8.8%).
(See the latest roundup of pharma stocks here: MRK, LLY, ABBV Post Q4 Earnings, PFE Ends Vupanorsen Program)
What’s next in the pharmaceutical world?
Watch for regular pipeline and regulatory updates next week.
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