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GSK Meets Study Goal for Co-Administered RSV-Shingles Vaccines
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GSK plc (GSK - Free Report) announced positive topline results from a phase III study evaluating the co-administration of its two marketed vaccines — RSV vaccine Arexvy and shingles vaccine Shingrix — in older adults (aged 50 years and older).
The study achieved its primary endpoint of non-inferior immune response — study participants who received the co-administered shot generated immune responses that were similar to those generated in participants who received each vaccine separately. Study participants who received the vaccine separately took Shingrix first followed by Arexvy at day 31.
The safety profile of the co-administered vaccine was also well-tolerated by study participants.
GSK plans to use the data from this late-stage study to support its regulatory submissions in the United States and Europe seeking approval for the co-administration of Arexvy and Shingrix shots.
GSK Stock Performance
The stock has increased 14.5% year to date compared with the industry’s 0.5% growth.
Image Source: Zacks Investment Research
GSK’s Vaccine Sales Slowing Down
GSK boasts a broad vaccine portfolio that targets infectious diseases like meningitis, shingles, flu, polio and many more. GSK has more than 20 marketed vaccines in its portfolio. Both Arexvy and Shingrix are key drivers of revenues for GSK’s vaccine segment. Since this year’s onset, vaccine sales have been faltering.
GSK’s Vaccine sales declined 2% in the United States in the first half of 2024 mainly due to declining sales of Shingrix. U.S. sales of Shingrix declined 19% in the first half of 2024 due to changes in retail vaccine prioritization due to a new Medicare rule, effective this January, which changed how pharmacies process reimbursements from payers. Lower demand is driven by challenges activating harder-to-reach consumers. U.S. sales of Shingrix are expected to remain soft in the second half.
Revised recommendations for RSV vaccinations issued in June by the US Advisory Committee on Immunization Practices (ACIP) are expected to hurt sales of Arexvy. In June, the ACIP recommended the use of Arexvy for all adults aged 75 and above. However, for adults aged 60-74, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease. The ACIP also postponed a vote for adults aged 50-59. GSK expects minimal sales of Arexvy in the 50-59 group in 2024 and also sales in the 60-74 group will be affected by ACIP’s recommendation.
It was due to these factors that, on the Q2 conference call, management lowered its vaccine sales growth expectations from a range of high single-digit to low double-digit percentage to a range of low to mid-single-digit percentage at CER in 2024.
How Co-administered Vaccine Could Help
Per management, RSV and shingles are common viruses that pose major health risks to older adults in the United States — RSV causes nearly 177,000 hospitalizations and 14,000 deaths every year. At the same time, around a million people develop shingles annually.
By way of co-administration, GSK intends to improve adult immunization rates while at the same time ‘reducing the number of visits to the healthcare offices and pharmacies’.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share (EPS) have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 121.8%.
BVS’ earnings beat estimates in three of the last four quarters and missed the mark on one occasion. Bioventus delivered a four-quarter average earnings surprise of 102.86%.
In the past 60 days, estimates for Illumina’s 2024 EPS have risen from $1.84 to $3.63. Estimates for 2025 have increased from $3.22 to $4.43 during the same period. Year to date, Illumina’s shares have lost 5.9%.
Earnings of Illumina beat estimates in each of the last four quarters. Illumina delivered a four-quarter average earnings surprise of 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have risen from $2.09 to $2.38. Estimates for 2025 have increased from $4.33 to $7.31 during the same period. Year to date, Krystal Biotech’s shares have gained 47.3%.
Earnings of Krystal Biotech beat estimates in three of the last four quarters and missed the mark on one occasion. Krystal Biotech delivered a four-quarter average earnings surprise of 45.95%.
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GSK Meets Study Goal for Co-Administered RSV-Shingles Vaccines
GSK plc (GSK - Free Report) announced positive topline results from a phase III study evaluating the co-administration of its two marketed vaccines — RSV vaccine Arexvy and shingles vaccine Shingrix — in older adults (aged 50 years and older).
The study achieved its primary endpoint of non-inferior immune response — study participants who received the co-administered shot generated immune responses that were similar to those generated in participants who received each vaccine separately. Study participants who received the vaccine separately took Shingrix first followed by Arexvy at day 31.
The safety profile of the co-administered vaccine was also well-tolerated by study participants.
GSK plans to use the data from this late-stage study to support its regulatory submissions in the United States and Europe seeking approval for the co-administration of Arexvy and Shingrix shots.
GSK Stock Performance
The stock has increased 14.5% year to date compared with the industry’s 0.5% growth.
Image Source: Zacks Investment Research
GSK’s Vaccine Sales Slowing Down
GSK boasts a broad vaccine portfolio that targets infectious diseases like meningitis, shingles, flu, polio and many more. GSK has more than 20 marketed vaccines in its portfolio. Both Arexvy and Shingrix are key drivers of revenues for GSK’s vaccine segment. Since this year’s onset, vaccine sales have been faltering.
GSK’s Vaccine sales declined 2% in the United States in the first half of 2024 mainly due to declining sales of Shingrix. U.S. sales of Shingrix declined 19% in the first half of 2024 due to changes in retail vaccine prioritization due to a new Medicare rule, effective this January, which changed how pharmacies process reimbursements from payers. Lower demand is driven by challenges activating harder-to-reach consumers. U.S. sales of Shingrix are expected to remain soft in the second half.
Revised recommendations for RSV vaccinations issued in June by the US Advisory Committee on Immunization Practices (ACIP) are expected to hurt sales of Arexvy. In June, the ACIP recommended the use of Arexvy for all adults aged 75 and above. However, for adults aged 60-74, the ACIP recommended the vaccine only for those who are at increased risk of severe RSV disease. The ACIP also postponed a vote for adults aged 50-59. GSK expects minimal sales of Arexvy in the 50-59 group in 2024 and also sales in the 60-74 group will be affected by ACIP’s recommendation.
It was due to these factors that, on the Q2 conference call, management lowered its vaccine sales growth expectations from a range of high single-digit to low double-digit percentage to a range of low to mid-single-digit percentage at CER in 2024.
How Co-administered Vaccine Could Help
Per management, RSV and shingles are common viruses that pose major health risks to older adults in the United States — RSV causes nearly 177,000 hospitalizations and 14,000 deaths every year. At the same time, around a million people develop shingles annually.
By way of co-administration, GSK intends to improve adult immunization rates while at the same time ‘reducing the number of visits to the healthcare offices and pharmacies’.
GSK’s Zacks Rank
GSK currently carries a Zacks Rank #3 (Hold).
GSK PLC Sponsored ADR Price
GSK PLC Sponsored ADR price | GSK PLC Sponsored ADR Quote
Our Key Picks Among Biotech Stocks
Some better-ranked stocks in the overall healthcare sector are Bioventus (BVS - Free Report) , Illumina (ILMN - Free Report) and Krystal Biotech (KRYS - Free Report) . Each stock presently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share (EPS) have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 121.8%.
BVS’ earnings beat estimates in three of the last four quarters and missed the mark on one occasion. Bioventus delivered a four-quarter average earnings surprise of 102.86%.
In the past 60 days, estimates for Illumina’s 2024 EPS have risen from $1.84 to $3.63. Estimates for 2025 have increased from $3.22 to $4.43 during the same period. Year to date, Illumina’s shares have lost 5.9%.
Earnings of Illumina beat estimates in each of the last four quarters. Illumina delivered a four-quarter average earnings surprise of 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have risen from $2.09 to $2.38. Estimates for 2025 have increased from $4.33 to $7.31 during the same period. Year to date, Krystal Biotech’s shares have gained 47.3%.
Earnings of Krystal Biotech beat estimates in three of the last four quarters and missed the mark on one occasion. Krystal Biotech delivered a four-quarter average earnings surprise of 45.95%.