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Biotech Stock Roundup: BMY, GSK, BIIB's Q2 Results, VTVT Down on Setback
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Second-quarter results by bigwigs were in the spotlight in the biotech sector this week. Additionally, important regulatory events grabbed investors’ focus.
Recap of the Week’s Most Important Stories:
BMY, GSK Q2 Results: Bristol Myers Squibb Company (BMY - Free Report) reported an adjusted earnings per share (EPS) of $2.07, which beat the Zacks Consensus Estimate of $1.64 and was up from $1.75 reported a year ago. Total revenues of $12.2 billion surpassed the Zacks Consensus Estimate of $11.5 billion. The top line also increased 9% from the year-ago period’s level, primarily driven by strong growth portfolio performance and an increase in Eliquis sales. Bristol Myers now expects adjusted earnings to be in the range of $0.60-$0.90 per share in 2024, up from the earlier estimated band of $0.40-$0.70.
GSK plc (GSK - Free Report) reported core earnings of $1.09 per American depositary share (ADS) in second-quarter 2024. The figure beat the Zacks Consensus Estimate of $1.00 per ADS. Core earnings rose 12% year over year on a reported basis and 13% at a constant exchange rate (CER).
Quarterly revenues increased 10% on a reported basis and 13% at CER to $9.95 billion (£7.88 billion), which beat the Zacks Consensus Estimate of $9.49 billion. The upside can be attributed to rising HIV and respiratory product sales. Based on strong first-half results, GSK raised its guidance for 2024. The company expects sales to increase 7-9% at CER for the full year compared with the previously issued guidance of an increase toward the upper end of 5-7%.
Biogen’s Q2 Earnings, Setback for Leqembi: Biogen (BIIB - Free Report) reported second-quarter 2024 adjusted EPS of $5.28, which beat the Zacks Consensus Estimate of $4.00. Total revenues came in at $2.47 billion, flat year over year on a reported basis and up 1% at cc as lower sales of key multiple sclerosis drugs like Tecfidera and Tysabri, as well as spinal muscular atrophy drug, Spinraza, were partially offset by higher revenues from new drugs. Sales also beat the Zacks Consensus Estimate of $2.38 billion.
Earlier, Biogen and its Japanese partner, Eisai, recently announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has given a negative opinion regarding the marketing approval for their anti-amyloid beta therapy, Leqembi (lecanemab), for early Alzheimer’s disease in European Union. Shares of Biogen plummeted on the setback.
Results from the main study showed that the CDR-SB score (a dementia rating scale) in patients treated with Leqembi increased 1.21 compared with 1.66 in those who received placebo after 18 months of treatment.
Although patients given Leqembi had lower CDR-SB scores than those given placebo, the difference between the two groups was small. Hence, the CHMP believes that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious adverse events associated with the drug.
The most important safety concern with Leqembi is the frequent occurrence of amyloid-related imaging abnormalities (ARIA), leading to swelling and potential bleeding in the brain. Some patients had serious events, including large bleeds in the brain, which required hospitalization even though most cases of ARIA in the main study were not serious and did not involve symptoms. In addition, the CHMP was concerned by the fact that the risk of ARIA is more pronounced in people who have a certain form of the gene for the protein apolipoprotein E called ApoE4.
Setback for VTVT: Shares of vTv Therapeutics Inc. (VTVT - Free Report) , a late-stage biopharmaceutical company, declined following the announcement of a clinical hold placed by the FDA on the cadisegliatin clinical program, which includes the ongoing CATT1 phase III study in type 1 diabetes.
The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion study of cadisegliatin, an oral, liver selective, glucokinase activator, which could not be resolved by standard mass spectroscopy. The FDA requires a single in vitro study to characterize this signal before the cadisegliatin program can resume. The earlier studies did not reveal any clinically concerning safety issue and no patient was dosed in the CATT1 at the time of the clinical hold.
Image: Bigstock
Biotech Stock Roundup: BMY, GSK, BIIB's Q2 Results, VTVT Down on Setback
Second-quarter results by bigwigs were in the spotlight in the biotech sector this week. Additionally, important regulatory events grabbed investors’ focus.
Recap of the Week’s Most Important Stories:
BMY, GSK Q2 Results: Bristol Myers Squibb Company (BMY - Free Report) reported an adjusted earnings per share (EPS) of $2.07, which beat the Zacks Consensus Estimate of $1.64 and was up from $1.75 reported a year ago. Total revenues of $12.2 billion surpassed the Zacks Consensus Estimate of $11.5 billion. The top line also increased 9% from the year-ago period’s level, primarily driven by strong growth portfolio performance and an increase in Eliquis sales. Bristol Myers now expects adjusted earnings to be in the range of $0.60-$0.90 per share in 2024, up from the earlier estimated band of $0.40-$0.70.
GSK plc (GSK - Free Report) reported core earnings of $1.09 per American depositary share (ADS) in second-quarter 2024. The figure beat the Zacks Consensus Estimate of $1.00 per ADS. Core earnings rose 12% year over year on a reported basis and 13% at a constant exchange rate (CER).
Quarterly revenues increased 10% on a reported basis and 13% at CER to $9.95 billion (£7.88 billion), which beat the Zacks Consensus Estimate of $9.49 billion. The upside can be attributed to rising HIV and respiratory product sales. Based on strong first-half results, GSK raised its guidance for 2024. The company expects sales to increase 7-9% at CER for the full year compared with the previously issued guidance of an increase toward the upper end of 5-7%.
BMY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biogen’s Q2 Earnings, Setback for Leqembi: Biogen (BIIB - Free Report) reported second-quarter 2024 adjusted EPS of $5.28, which beat the Zacks Consensus Estimate of $4.00. Total revenues came in at $2.47 billion, flat year over year on a reported basis and up 1% at cc as lower sales of key multiple sclerosis drugs like Tecfidera and Tysabri, as well as spinal muscular atrophy drug, Spinraza, were partially offset by higher revenues from new drugs. Sales also beat the Zacks Consensus Estimate of $2.38 billion.
Earlier, Biogen and its Japanese partner, Eisai, recently announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has given a negative opinion regarding the marketing approval for their anti-amyloid beta therapy, Leqembi (lecanemab), for early Alzheimer’s disease in European Union. Shares of Biogen plummeted on the setback.
Results from the main study showed that the CDR-SB score (a dementia rating scale) in patients treated with Leqembi increased 1.21 compared with 1.66 in those who received placebo after 18 months of treatment.
Although patients given Leqembi had lower CDR-SB scores than those given placebo, the difference between the two groups was small. Hence, the CHMP believes that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious adverse events associated with the drug.
The most important safety concern with Leqembi is the frequent occurrence of amyloid-related imaging abnormalities (ARIA), leading to swelling and potential bleeding in the brain. Some patients had serious events, including large bleeds in the brain, which required hospitalization even though most cases of ARIA in the main study were not serious and did not involve symptoms. In addition, the CHMP was concerned by the fact that the risk of ARIA is more pronounced in people who have a certain form of the gene for the protein apolipoprotein E called ApoE4.
Setback for VTVT: Shares of vTv Therapeutics Inc. (VTVT - Free Report) , a late-stage biopharmaceutical company, declined following the announcement of a clinical hold placed by the FDA on the cadisegliatin clinical program, which includes the ongoing CATT1 phase III study in type 1 diabetes.
The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion study of cadisegliatin, an oral, liver selective, glucokinase activator, which could not be resolved by standard mass spectroscopy. The FDA requires a single in vitro study to characterize this signal before the cadisegliatin program can resume. The earlier studies did not reveal any clinically concerning safety issue and no patient was dosed in the CATT1 at the time of the clinical hold.
Performance
The Nasdaq Biotechnology Index has gained 0.58% in the past five trading sessions and BMY’s shares have risen 6.49%. In the past six months, shares of MRNA have rallied 17.98%. (See the last biotech stock roundup here: Biotech Stock Roundup: SAGE Plunges on Study Failure, AGEN Down on Regulatory Update & More)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more earnings and pipeline updates.