Latest news with #SpecialtyMedicines
Yahoo
30-07-2025
- Business
- Yahoo
GSK Lifts Outlook As Specialty Medicines, Vaccines Fuel Growth
British pharmaceutical giant GSK Plc (NYSE:GSK) shares rose on Wednesday after reporting second-quarter results that surpassed analyst expectations and led the company to raise its full-year 2025 guidance. Driven by exceptional growth in Specialty Medicines and Vaccines, GSK's second-quarter sales reached $10.66 billion (7.98 billion British pounds), a 6% increase at constant currency, exceeding analyst estimates of $10.33 billion. Core earnings jumped 15% at constant currency to $1.24 per share (46.5 pence) outperforming the consensus forecast of $ company attributed this core earnings growth to the strong performance of its Specialty Medicines and Vaccines divisions, coupled with higher royalty income and a disciplined escalation of investment in key research and development (R&D) areas, particularly within Oncology and Vaccines. Vaccine sales jumped 5% (+9% at constant currency or cc) to 2.09 billion pounds, reflecting growth in Meningitis vaccines related to uptake following expanded recommendation and public funding of Bexsero in Europe, as well as growth in Shingrix driven by launch uptake in France and strong demand across several other European markets and Japan. Arexvy sales reached 66 million pounds, up 6% (+13% cc). Meningitis vaccine sales increased 17% (+22% cc) to 379 million, while established vaccine sales of 787 million increased 2% (+6% cc). Shingrix sales reached 853 million pounds, up 3% (+6% cc). In July, the FDA agreed to review the application to extend the indication of Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18-49 who are at increased risk. Also in July, the FDA extended the review period for the Biologics License Application (BLA) for GSK's Blenrep combinations for relapsed or refractory multiple myeloma patients who have received at least one prior line of therapy. View more earnings on GSK Specialty Medicines sales grew by double-digit percentages (+10% and 15% cc) in the quarter to 3.33 billion pounds, reflecting continued growth across disease areas, with strong performances in HIV, Respiratory, Immunology & Inflammation, and Oncology. General Medicines sales fell by 10% (-6% cc) to 2.57 billion pounds. GSK is progressing on 14 major pipeline opportunities, each with a potential value of over 2 billion pounds, set to launch between 2025 and 2031. Phase 3 study for tebipenem, a new antibiotic for complicated urinary tract infections, was stopped early because it worked so well. The company plans to file for approval by the end of the year. Phase 3 development for depemokimab, aimed at treating COPD, has begun with the launch of the ENDURA study program. Key trials expected to begin in the second half of 2025 include GSK'227, a B7H3-targeting antibody-drug conjugate for small cell lung cancer, GSK'981 (IDRx-42) for second-line treatment of gastrointestinal stromal tumors, Efimosfermin for MASH, and an ultra-long-acting injectable HIV treatment combining cabotegravir and rilpivirine, to be given every four months. Tariff Outlook and Guidance Addressing a broader macroeconomic concern, GSK acknowledged the U.S. Administration's initiation of an investigation under Section 232 of the Trade Expansion Act, which seeks to ascertain the potential effects of pharmaceutical product imports on national security. The company said it is well-positioned to respond to the potential financial impact of tariffs, with mitigation options identified. According to Reuters, GSK's CFO indicated an anticipation of some tariffs coming in the second half of the year, which are expected to lower the gross margin slightly. GSK raised its full-year 2025 guidance and says it includes tariffs enacted thus far and the European tariffs indicated this week. It now expects sales to increase toward the top of the 3%–5% range. Core operating profit and earnings are also expected to grow towards the top end of the 6% to 8% range. Specialty Medicine sales are expected to increase in the low teens versus prior guidance of a low double-digit percentage. Vaccine revenue is expected to decline by a low single-digit percent to broadly stable compared to the prior outlook of a decrease of low single-digit percent, and general medicine sales are expected to be broadly stable. Price Action: At last check on Wednesday, GSK stock was up 3.57% to $40.37 during the premarket session. Read Next:Photo by HJBC via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? GSK (GSK): Free Stock Analysis Report This article GSK Lifts Outlook As Specialty Medicines, Vaccines Fuel Growth originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
09-07-2025
- Business
- Globe and Mail
GSK's Specialty Medicines Unit on a Strong Footing: Here's Why
GSK plc 's GSK Specialty Medicines segment includes medicines that prevent and treat diseases like HIV, cancer, asthma and immune-inflammation diseases like lupus. Specialty Medicines now represents close to 40% of GSK's sales. The company is witnessing increased sales growth of its Specialty Medicines unit, particularly reflecting successful new launches in Oncology and long-acting HIV medicines. Sales are rising in all areas, HIV, Immunology/Respiratory as well as Oncology. Sales of the Specialty Medicines unit rose 17% in the first quarter of 2025. In the segment, while products like Nucala and Dovato are key top-line drivers, new long-acting HIV medicines, Cabenuva and Apretude, as well as new oncology drugs Jemperli and Ojjaara, are also witnessing strong patient demand and contributing to top-line growth. GSK is also increasing R&D investment in promising new long-acting and specialty medicines in Respiratory, Immunology & Inflammation, Oncology and HIV areas. Blujepa/gepotidacin for treating uncomplicated urinary tract infection ('UTI') was approved in the United States in the first quarter of 2025. Its blockbuster drug Nucala was approved for treating chronic obstructive pulmonary disease or COPD, its fifth indication, in May 2025. Regulatory applications seeking approval of the Blenrep combination for relapsed/refractory multiple myeloma and depemokimab for two indications (chronic rhinosinusitis with nasal polyps or CRSwNP and asthma with type II inflammation) are under review in the United States and some other countries. FDA decisions on all these filings are expected in 2025. Blenrep combinations were approved in the United Kingdom and Japan in April/May 2025. Backed by its existing portfolio of medicines as well as new drugs, GSK expects sales in the Specialty Medicines segment to rise in a low double-digit percentage at CER in 2025, despite the impact from the Inflation Reduction Act or IRA. Specialty Medicines, which now accounts for around 40% of GSK's sales, is expected to be more than 50% of GSK's total revenues by 2031. Competition for GSK's Specialty Medicines In the Specialty Medicines segment, most of GSK's products are up against significant competition from small as well as large pharmaceutical companies like AstraZeneca AZN, Merck MRK, Sanofi SNY, Gilead, Pfizer, J&J and Novartis, among others. In the respiratory market, Advair is facing stiff competition in the COPD and asthma markets from AstraZeneca and Merck's respiratory disease drugs. The launch of AstraZeneca's Fasenra and Sanofi's Dupixent has raised competitive pressure for Nucala. Continued competitive and pricing pressure is hurting sales of GSK's ICS/LABA class of medicines. In HIV, GSK's medicines face competition from Gilead and MRK's drugs. AstraZeneca, Pfizer, Merck and Lilly are GSK's key competitors in the oncology space. GSK's Price Performance, Valuation and Estimates GSK stock has risen 16.3% year to date compared with an increase of 0.3% for the industry. GSK's stock is trading at an attractive valuation relative to the industry. Going by the price/earnings ratio, the company's shares currently trade at 8.34 on a forward 12-month basis, lower than 14.93 for the industry. The stock also trades below its 5-year mean of 10.21. The Zacks Consensus Estimate for earnings has risen from $4.38 to $4.41 per share for 2025 but declined from $4.82 to $4.81 per share for 2026 over the past 60 days. GSK has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in the coming year. While not all picks can be winners, previous recommendations have soared +112%, +171%, +209% and +232%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. Today, See These 5 Potential Home Runs >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Sanofi (SNY): Free Stock Analysis Report AstraZeneca PLC (AZN): Free Stock Analysis Report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Merck & Co., Inc. (MRK): Free Stock Analysis Report
Yahoo
18-06-2025
- Business
- Yahoo
GSK Stock Rises Almost 22% in 6 Months: Time to Buy, Sell or Hold?
GSK GSK stock has risen 21.5% in the past six months. The consistently strong performance of the Specialty Medicines unit, regulatory and pipeline successes and an optimistic outlook for the long term are the key factors driving the increase amid several headwinds like slowing sales in the Vaccines unit, generic competition for some drugs and broader economic pressure. Let's discuss these factors in detail to understand how to play GSK's stock amid the recent price increase. GSK is witnessing increased sales growth of its Specialty Medicines unit, particularly reflecting successful new launches in Oncology and long-acting HIV medicines. Sales are rising in all areas, HIV, Immunology/Respiratory as well as Oncology. Sales of the Specialty Medicines unit rose 19% in 2024, driven by double-digit growth in all therapy areas. The positive trend continues in 2025 with sales rising 17% in the first quarter of 2025. In the segment, while products like Nucala and Dovato are key top-line drivers, new long-acting HIV medicines, Cabenuva and Apretude, as well as new oncology drugs Jemperli and Ojjaara, are also witnessing strong patient demand and contributing to top-line growth. In 2025, the company expects sales in the Specialty Medicines segment to rise in a low double-digit percentage at CER, despite the impact from the Inflation Reduction Act or IRA. Specialty Medicines, which now accounts for around 40% of GSK's sales, is expected to be more than 50% of GSK's total revenue by 2031. GSK is increasing R&D investment in promising new long-acting and specialty medicines in Respiratory, Immunology & Inflammation, Oncology and HIV areas. GSK's pentavalent MenABCWY meningococcal vaccine and Blujepa/gepotidacin for treating uncomplicated urinary tract infection ('UTI') were approved in the United States in the first quarter of 2025. Its blockbuster drug Nucala was approved for treating chronic obstructive pulmonary disease or COPD, its fifth indication, in May 2025. Regulatory applications seeking approval of the Blenrep combination for relapsed/refractory multiple myeloma and depemokimab for two indications (chronic rhinosinusitis with nasal polyps or CRSwNP and asthma with type II inflammation) are under review in the United States and some other countries. FDA decisions on all these filings are expected in 2025. Blenrep combinations were approved in the United Kingdom and Japan in April/May 2025. In 2025, GSK expects to launch five new products/line extensions, including Blenrep, depemokimab (severe asthma and CRSwNP), Nucala for COPD, Penmenvy and Blujepa. Of these, Penmenvy, Blujepa and Nucala for COPD are already approved in the United States. GSK's first-quarter Vaccine sales declined 6% due to lower sales of its RSV vaccine, Arexvy, and shingles vaccine, Shingrix. U.S. sales of Shingrix declined 21% in the first quarter of 2025 due to lower demand as a result of challenges in activating harder-to-reach consumers. Arexvy's global sales declined 57% in the first quarter. Revised recommendations for RSV vaccinations issued in June 2024 by the U.S. Advisory Committee on Immunization Practices (ACIP) have been hurting sales of Arexvy from the second half of 2024 in the United States. 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. A challenging macro environment in China and potential for changes in vaccination policies in the United States are expected to hurt Vaccine sales in the near term. In 2025, the company expects sales in the Vaccines segment to decline by a low single-digit percentage at CER. GSK stock has risen 20.1% year to date compared with an increase of 4.0% for the industry. The stock has also outperformed the sector and the S&P 500 index, as seen in the chart below. The stock has also been trading above 200 and 50-day moving averages since May. Image Source: Zacks Investment Research GSK's stock is trading at an attractive valuation relative to the industry. Going by the price/earnings ratio, the company's shares currently trade at 8.63 on a forward 12-month basis, lower than 15.63 for the industry. The stock also trades below its 5-year mean of 10.25. The stock is much cheaper than several other large drugmakers like Eli Lilly LLY, Novo Nordisk NVO, AbbVie ABBV and AstraZeneca. Image Source: Zacks Investment Research The Zacks Consensus Estimate for earnings has risen from $4.26 to $4.42 per share for 2025 and from $4.71 to $4.82 per share for 2026 over the past 60 days. Image Source: Zacks Investment Research GSK has its share of problems. Competitive pressure on HIV and respiratory drugs has risen. The dolutegravir HIV franchise patent expires in the 2028-2029 period, and U.S. vaccine sales are slowing down. In 2025, GSK also expects a negative sales impact of £400-500 million due to the impact of the IRA Medicare Part D redesign. However, the company is consistently growing its sales and profits, mainly driven by its Specialty Medicines segment. For the five-year period till 2026, GSK expects to record more than 7% sales growth while core operating profit is expected to increase more than 11% on a CAGR basis. In this period, Specialty Medicines is expected to rise in the low-to-mid teens percentage while General Medicines is expected to rise by a low single-digit percentage. The growth in Specialty Medicines and improvement in General Medicines are making up for a slowdown in the Vaccines unit. The company also resolved the vast majority of Zantac litigations in 2024, which had long been an overhang on the stock. GSK believes it is well-positioned to navigate and mitigate the potential financial impact of tariffs on pharmaceutical imports through supply chain and increased productivity initiatives We suggest investors who own this Zacks Rank #3 (Hold) stock stay invested for now, considering steady sales and profit improvement in the coming years. Consistently rising estimates also reflect analysts' optimistic outlook for future growth in profits. Buying the stock at its present cheap valuation can prove prudent for long-term investors who are interested in buying blue-chip companies. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report AbbVie Inc. (ABBV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
18-06-2025
- Business
- Globe and Mail
GSK Stock Rises Almost 22% in 6 Months: Time to Buy, Sell or Hold?
GSK GSK stock has risen 21.5% in the past six months. The consistently strong performance of the Specialty Medicines unit, regulatory and pipeline successes and an optimistic outlook for the long term are the key factors driving the increase amid several headwinds like slowing sales in the Vaccines unit, generic competition for some drugs and broader economic pressure. Let's discuss these factors in detail to understand how to play GSK's stock amid the recent price increase. GSK Specialty Medicines Unit on a Strong Footing GSK is witnessing increased sales growth of its Specialty Medicines unit, particularly reflecting successful new launches in Oncology and long-acting HIV medicines. Sales are rising in all areas, HIV, Immunology/Respiratory as well as Oncology. Sales of the Specialty Medicines unit rose 19% in 2024, driven by double-digit growth in all therapy areas. The positive trend continues in 2025 with sales rising 17% in the first quarter of 2025. In the segment, while products like Nucala and Dovato are key top-line drivers, new long-acting HIV medicines, Cabenuva and Apretude, as well as new oncology drugs Jemperli and Ojjaara, are also witnessing strong patient demand and contributing to top-line growth. In 2025, the company expects sales in the Specialty Medicines segment to rise in a low double-digit percentage at CER, despite the impact from the Inflation Reduction Act or IRA. Specialty Medicines, which now accounts for around 40% of GSK's sales, is expected to be more than 50% of GSK's total revenue by 2031. GSK's Promising Pipeline GSK is increasing R&D investment in promising new long-acting and specialty medicines in Respiratory, Immunology & Inflammation, Oncology and HIV areas. GSK's pentavalent MenABCWY meningococcal vaccine and Blujepa/gepotidacin for treating uncomplicated urinary tract infection ('UTI') were approved in the United States in the first quarter of 2025. Its blockbuster drug Nucala was approved for treating chronic obstructive pulmonary disease or COPD, its fifth indication, in May 2025. Regulatory applications seeking approval of the Blenrep combination for relapsed/refractory multiple myeloma and depemokimab for two indications (chronic rhinosinusitis with nasal polyps or CRSwNP and asthma with type II inflammation) are under review in the United States and some other countries. FDA decisions on all these filings are expected in 2025. Blenrep combinations were approved in the United Kingdom and Japan in April/May 2025. In 2025, GSK expects to launch five new products/line extensions, including Blenrep, depemokimab (severe asthma and CRSwNP), Nucala for COPD, Penmenvy and Blujepa. Of these, Penmenvy, Blujepa and Nucala for COPD are already approved in the United States. GSK's Vaccine Sales Slowing Down GSK's first-quarter Vaccine sales declined 6% due to lower sales of its RSV vaccine, Arexvy, and shingles vaccine, Shingrix. U.S. sales of Shingrix declined 21% in the first quarter of 2025 due to lower demand as a result of challenges in activating harder-to-reach consumers. Arexvy's global sales declined 57% in the first quarter. Revised recommendations for RSV vaccinations issued in June 2024 by the U.S. Advisory Committee on Immunization Practices (ACIP) have been hurting sales of Arexvy from the second half of 2024 in the United States. 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. A challenging macro environment in China and potential for changes in vaccination policies in the United States are expected to hurt Vaccine sales in the near term. In 2025, the company expects sales in the Vaccines segment to decline by a low single-digit percentage at CER. GSK's Price Performance, Valuation & Estimate Movement GSK stock has risen 20.1% year to date compared with an increase of 4.0% for the industry. The stock has also outperformed the sector and the S&P 500 index, as seen in the chart below. The stock has also been trading above 200 and 50-day moving averages since May. GSK Stock Outperforms Industry, Sector and S&P GSK's stock is trading at an attractive valuation relative to the industry. Going by the price/earnings ratio, the company's shares currently trade at 8.63 on a forward 12-month basis, lower than 15.63 for the industry. The stock also trades below its 5-year mean of 10.25. The stock is much cheaper than several other large drugmakers like Eli Lilly LLY, Novo Nordisk NVO, AbbVie ABBV and AstraZeneca. GSK Stock Valuation Image Source: Zacks Investment Research The Zacks Consensus Estimate for earnings has risen from $4.26 to $4.42 per share for 2025 and from $4.71 to $4.82 per share for 2026 over the past 60 days. GSK's Estimates Stay Invested in GSK Stock GSK has its share of problems. Competitive pressure on HIV and respiratory drugs has risen. The dolutegravir HIV franchise patent expires in the 2028-2029 period, and U.S. vaccine sales are slowing down. In 2025, GSK also expects a negative sales impact of £400-500 million due to the impact of the IRA Medicare Part D redesign. However, the company is consistently growing its sales and profits, mainly driven by its Specialty Medicines segment. For the five-year period till 2026, GSK expects to record more than 7% sales growth while core operating profit is expected to increase more than 11% on a CAGR basis. In this period, Specialty Medicines is expected to rise in the low-to-mid teens percentage while General Medicines is expected to rise by a low single-digit percentage. The growth in Specialty Medicines and improvement in General Medicines are making up for a slowdown in the Vaccines unit. The company also resolved the vast majority of Zantac litigations in 2024, which had long been an overhang on the stock. GSK believes it is well-positioned to navigate and mitigate the potential financial impact of tariffs on pharmaceutical imports through supply chain and increased productivity initiatives We suggest investors who own this Zacks Rank #3 (Hold) stock stay invested for now, considering steady sales and profit improvement in the coming years. Consistently rising estimates also reflect analysts' optimistic outlook for future growth in profits. Buying the stock at its present cheap valuation can prove prudent for long-term investors who are interested in buying blue-chip companies. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in the coming year. While not all picks can be winners, previous recommendations have soared +112%, +171%, +209% and +232%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. Today, See These 5 Potential Home Runs >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Novo Nordisk A/S (NVO): Free Stock Analysis Report Eli Lilly and Company (LLY): Free Stock Analysis Report AbbVie Inc. (ABBV): Free Stock Analysis Report
Western Telegraph
30-04-2025
- Business
- Western Telegraph
Drugs giant GSK ‘well positioned' to absorb potential US tariffs
It came as the FTSE 100 giant revealed a rise in sales as weakness in its vaccine division was offset by growth in speciality medicines. GSK reported total sales grew by 4% to £7.52 billion for the first quarter of 2025, compared with a year earlier. This came on the back of a boost from its speciality medicines division, where sales rose 17% on the back of strong demand for oncology, respiratory and HIV treatments. It helped to offset another decline in its vaccines arm, where sales dropped by 6% to £2.1 billion for the quarter. The group said it is on track for turnover to increase by between 3% and 5% over the current year, in line with previous guidance. It held financial guidance for the year despite uncertainty over US tariffs, with the Trump administration currently investigating whether to change tariff policy for the sector. GSK chief executive Emma Walmsley said the business is making 'strong progress' (GSK/PA) 'The company is well positioned to respond to the potential financial impact of sector-specific tariffs, should they be implemented, with mitigation options identified in the supply chain and productivity initiatives,' GSK told shareholders on Wednesday. 'The company will continue to monitor and review developments related to this situation.' GSK was among pharmaceutical firms to recently call on the European Union to allow them to increase prices amid uncertainty over tariffs in the sector, warning Europe it will fall further behind the US without stronger investment incentives. Chief executive Emma Walmsley said: 'GSK continues to make strong progress, demonstrating the quality, strength and resilience of our portfolio. 'Specialty Medicines, our largest business, delivered strong sales contributions in the quarter and R&D progress continued, with two of the five FDA product approvals expected this year now secured, and the acquisition of a promising new oncology asset. 'This momentum, together with the strength of our portfolio and proven ability to drive operating leverage, underpin our confidence in guidance for the year and our longer-term outlooks.' Shares in the company were 2% higher in early trading on Wednesday.
