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Over the past week, earnings took center stage in the biotech sector as most bigwigs like Bristol-Myers (BMY - Free Report) , Amgen (AMGN - Free Report) , Regeneron (REGN - Free Report) and Biogen (BIIB - Free Report) reported fourth-quarter results. Also, pipeline and regulatory updates grabbed the spotlight in the sector.
Recap of the Week’s Most Important Stories:
Q4 Earnings Results: Bristol-Myers reported in-line fourth-quarter 2021 earnings while sales beat estimates on strong performance of blood thinner drug Eliquis and immuno-oncology Opdivo. Earnings of $1.83 per share matched the Zacks Consensus Estimate and increased from $1.46 reported in the year-ago quarter. Total revenues of $11.98 billion surpassed the Zacks Consensus Estimate of $11.96 billion and increased 8% from the year-ago period. Myeloma drug, Revlimid, contributed $3.3 billion to revenues and was the top revenue generator for Bristol-Myers.
Regeneron reported strong fourth-quarter results with both earnings and sales beating estimates on strong growth in ophthalmology drug Eylea and asthma drug Dupixent. Contribution from REGEN-COV, its antibody cocktail for COVID-19, also boosted the top line. However, the lack of efficacy of REGEN-COV against the Omicron variant and subsequent revision of its Emergency Use Authorization will impact the top line in 2022.
Biogen too beat on both counts. Fourth-quarter 2021 earnings per share of $3.39 beat the Zacks Consensus Estimate of $3.32. Sales of $2.73 billion topped the Zacks Consensus Estimate of $2.62 billion. However, sales were down 4% from the year-ago quarter due to lower sales of Tecfidera and Spinraza.
Amgen reported mixed results for the quarter. Earnings of $4.36 per share beat the Zacks Consensus Estimate of $4.14. Earnings also rose 26% year over year, driven by higher revenues and lower share count. However, total revenues of $6.85 billion missed the Zacks Consensus Estimate of $6.91 billion. On a year-over-year basis, revenues were up driven by higher Other Revenue from the Eli Lilly collaboration, which offset the decline in product sales.
Vanda Down on Study Update: Shares of Vanda Pharmaceuticals Inc. VNDA were down after the company reported disappointing results from its phase III study, VP-VLY-686-3303. The study evaluated the efficacy and safety of tradipitant in treating the symptoms of gastroparesis. The study did not meet its prespecified primary endpoint, which was the difference between drug and placebo on the change of the severity of nausea from baseline at week 12 of treatment. Both treatment arms showed significant improvements from baseline on nausea and the other core symptoms of gastroparesis.
Per the company, initial exploratory analysis has identified potential confounders that may have masked the beneficial effect of the drug previously observed in the phase II study of tradipitant, which include a baseline imbalance of rescue medication use between the two treatment arms as well as observed poor compliance with study drug for some patients in the study. When the analysis was restricted to the group of patients that used no rescue medications at baseline and adjusting for poor compliance, Vanda identified strong evidence of a drug effect across a number of symptoms and in the duration of the study, including a significant and meaningful effect at the prespecified primary endpoint of nausea change at week 12.
Biogen Announces Agreement for Biosimilar: Biogen announced that it has signed commercialization and license agreement with Sweden-based biological drug-maker, Xbrane Biopharma AB, to develop, manufacture and commercialize the latter’s pre-clinical biosimilar candidate, Xcimzane.
Xcimzane is a proposed biosimilar referencing rheumatoid arthritis drug, Cimzia. Per the agreement, Biogen will pay $8 million upfront and up to $80 million in potential milestone payments to Xbrane for exclusive global regulatory, manufacturing and commercial rights to Xcimzane. Biogen will be the marketing authorization holder following a potential approval to the candidate. Biogen will also pay royalties on potential sales of Xcimzane going forward. While Xbrane will be responsible for the pre-clinical development of Xcimzane, BIIB will undertake all remaining development activities.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has gained 1.86% in the past five trading sessions. Among the biotech giants, Amgen has gained 5.39% during the period. Over the past six months, shares of Vertex have soared 20.23%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD Q4 Earnings, REGN, MRNAs Regulatory Updates & More)
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What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates, along with earnings updates.
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Biotech Stock Roundup: BMY, AMGN, REGN, BIIB's Q4 Earnings & More
Over the past week, earnings took center stage in the biotech sector as most bigwigs like Bristol-Myers (BMY - Free Report) , Amgen (AMGN - Free Report) , Regeneron (REGN - Free Report) and Biogen (BIIB - Free Report) reported fourth-quarter results. Also, pipeline and regulatory updates grabbed the spotlight in the sector.
Recap of the Week’s Most Important Stories:
Q4 Earnings Results: Bristol-Myers reported in-line fourth-quarter 2021 earnings while sales beat estimates on strong performance of blood thinner drug Eliquis and immuno-oncology Opdivo. Earnings of $1.83 per share matched the Zacks Consensus Estimate and increased from $1.46 reported in the year-ago quarter. Total revenues of $11.98 billion surpassed the Zacks Consensus Estimate of $11.96 billion and increased 8% from the year-ago period. Myeloma drug, Revlimid, contributed $3.3 billion to revenues and was the top revenue generator for Bristol-Myers.
Regeneron reported strong fourth-quarter results with both earnings and sales beating estimates on strong growth in ophthalmology drug Eylea and asthma drug Dupixent. Contribution from REGEN-COV, its antibody cocktail for COVID-19, also boosted the top line. However, the lack of efficacy of REGEN-COV against the Omicron variant and subsequent revision of its Emergency Use Authorization will impact the top line in 2022.
Biogen too beat on both counts. Fourth-quarter 2021 earnings per share of $3.39 beat the Zacks Consensus Estimate of $3.32. Sales of $2.73 billion topped the Zacks Consensus Estimate of $2.62 billion. However, sales were down 4% from the year-ago quarter due to lower sales of Tecfidera and Spinraza.
Amgen reported mixed results for the quarter. Earnings of $4.36 per share beat the Zacks Consensus Estimate of $4.14. Earnings also rose 26% year over year, driven by higher revenues and lower share count. However, total revenues of $6.85 billion missed the Zacks Consensus Estimate of $6.91 billion. On a year-over-year basis, revenues were up driven by higher Other Revenue from the Eli Lilly collaboration, which offset the decline in product sales.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vanda Down on Study Update: Shares of Vanda Pharmaceuticals Inc. VNDA were down after the company reported disappointing results from its phase III study, VP-VLY-686-3303. The study evaluated the efficacy and safety of tradipitant in treating the symptoms of gastroparesis. The study did not meet its prespecified primary endpoint, which was the difference between drug and placebo on the change of the severity of nausea from baseline at week 12 of treatment. Both treatment arms showed significant improvements from baseline on nausea and the other core symptoms of gastroparesis.
Per the company, initial exploratory analysis has identified potential confounders that may have masked the beneficial effect of the drug previously observed in the phase II study of tradipitant, which include a baseline imbalance of rescue medication use between the two treatment arms as well as observed poor compliance with study drug for some patients in the study. When the analysis was restricted to the group of patients that used no rescue medications at baseline and adjusting for poor compliance, Vanda identified strong evidence of a drug effect across a number of symptoms and in the duration of the study, including a significant and meaningful effect at the prespecified primary endpoint of nausea change at week 12.
Biogen Announces Agreement for Biosimilar: Biogen announced that it has signed commercialization and license agreement with Sweden-based biological drug-maker, Xbrane Biopharma AB, to develop, manufacture and commercialize the latter’s pre-clinical biosimilar candidate, Xcimzane.
Xcimzane is a proposed biosimilar referencing rheumatoid arthritis drug, Cimzia. Per the agreement, Biogen will pay $8 million upfront and up to $80 million in potential milestone payments to Xbrane for exclusive global regulatory, manufacturing and commercial rights to Xcimzane. Biogen will be the marketing authorization holder following a potential approval to the candidate. Biogen will also pay royalties on potential sales of Xcimzane going forward. While Xbrane will be responsible for the pre-clinical development of Xcimzane, BIIB will undertake all remaining development activities.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has gained 1.86% in the past five trading sessions. Among the biotech giants, Amgen has gained 5.39% during the period. Over the past six months, shares of Vertex have soared 20.23%. (See the last biotech stock roundup here: Biotech Stock Roundup: GILD Q4 Earnings, REGN, MRNAs Regulatory Updates & More)
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates, along with earnings updates.