Key Points Company and Industry Overview 1. **GSK as a Global Biopharma Company**: GSK is a global biopharma company focused on the prevention and treatment of disease [3]. 2. **Demerger and Biopharma Focus**: GSK demerged its consumer business three years ago, creating a dedicated biopharma company with a clear focus on benefiting patients and shareholders [2]. Financial Performance 3. **2024 Sales and Profit Growth**: In the first nine months of 2024, GSK delivered 9% sales growth and 19% core operating profit growth [3]. 4. **Full-Year 2024 Guidance**: GSK confirmed its guidance for full-year 2024, expecting sales growth of 7% to 9% and core operating profit growth of 11% to 13% [5]. Product Approvals and Outlook 5. **Product Approvals and Growth Outlook**: GSK expects to secure five product approvals in the coming year and remains highly confident in delivering the growth outlooks set for 2026 and 2031 [5].

Company Overview - GSK is a global biopharma company focused on the prevention and treatment of disease [5] - The company demerged its consumer business three years ago to create a dedicated biopharma company with a clear focus on benefiting patients and shareholders [3] Financial Performance - For the full year 2024, GSK confirmed sales growth guidance of 7% to 9% and core operating profit growth of 11% to 13% [2] - In the first nine months of 2024, GSK delivered 9% sales growth and 19% core operating profit growth, reflecting strong momentum in Specialty Medicines and overall portfolio resilience [5] Strategic Outlook - GSK expects to secure five product approvals in 2025 [2] - The company has high confidence in delivering the growth outlooks set for 2026 and 2031 [2]

GSK plc (GSK) announced that the FDA has granted a Breakthrough Therapy Designation to its investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK’227), for the treatment of relapsed or refractory osteosarcoma in adult patients whose disease progressed on at least two prior lines of therapy.The FDA grants Breakthrough Therapy designation to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that the therapy ...

GSK plc’s (GSK) HIV subsidiary, ViiV Healthcare announced that the Europe Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion recommending marketing authorization for its new long-acting HIV regimen.ViiV Healthcare is a global specialist HIV company, majorly owned by GSK with Pfizer (PFE) and Shionogi as shareholders.ViiV Healthcare was formed by GSK and Pfizer in 2009.The CHMP recommended marketing authorization to Vocabria (cabotegravir long-a ...

GSK plc (GSK) announced that the FDA accepted its biologics license application (BLA) seeking approval for the Blenrep (belantamab mafodotin) combination therapy to treat relapsed or refractory multiple myeloma (RRMM) for review.The BLA seeks the approval of Blenrep in combination with J&J’s Velcade (bortezomib) plus dexamethasone (BorDex) or Bristol Myers’ Pomalyst (pomalidomide) plus dexamethasone (PomDex) for the treatment of patients with multiple myeloma who have received at least one prior line of the ...

GSK plc (GSK) announced positive headline data from the phase III GLISTEN study, which is evaluating its investigational targeted inhibitor of the ileal bile acid transporter (IBAT), linerixibat, for treating adult patients with cholestatic pruritus associated with primary biliary cholangitis (PBC).The global GLISTEN study met its primary endpoint by showing that treatment with linerixibat led to a statistically significant improvement in monthly itch score as compared with placebo over 24 weeks.Per managem ...

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - The news team covers a wide range of sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] - Proactive has a presence in key finance and investing hubs with bureaus and studios located in major cities such as London, New York, and Sydney [2] Group 2 - The company emphasizes the use of technology to enhance workflows and improve content production [4] - Proactive employs automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

President-elect Donald Trump this week nominated Robert F. Kennedy Jr. to be the next Secretary of ... [+] the U.S. Department of Health and Human Services. In this photo, the vaccine skeptic speaks during a hearing with the House Judiciary Subcommittee on the Weaponization of the Federal Government on Capitol Hill on July 20, 2023 in Washington, DC. (Photo by Anna Moneymaker/Getty Images)Getty ImagesStocks of major drug makers and biotech companies tumbled in trading late this week after President-elect Do ...

GSK plc (NYSE:GSK) Guggenheim's Inaugural Healthcare Innovation Conference November 12, 2024 2:00 PM ET Company Participants Emma Walmsley - Chief Executive Officer Conference Call Participants Seamus Fernandez - Guggenheim Seamus Fernandez I'm absolutely thrilled that this we're clearly going to have the best conversation in the fireside chat that we've had so far. Incredibly pleased to have Emma Walmsley here. She's CEO and on the Board of Directors of GlaxoSmithKline, or sorry, GSK. I have to, I can't s ...

Core Viewpoint - GSK reported third-quarter 2024 core earnings of $1.27 per American depositary share (ADS), exceeding the Zacks Consensus Estimate of $1.16, although core earnings declined 1% year over year on a reported basis but rose 5% at a constant exchange rate (CER) [1] - Quarterly revenues fell 2% on a reported basis but rose 2% at CER to $10.42 billion (£8.01 billion), missing the Zacks Consensus Estimate of $10.65 billion due to lower sales of RSV and shingles vaccines in the United States [1] Segment Performance - GSK operates under three segments: General Medicines, Specialty Medicines, and Vaccines. Sales in Specialty Medicines and General Medicines rose 19% and 7%, respectively, while vaccine sales declined 15% [3] Specialty Medicines - HIV sales increased by 12%, driven by strong demand for two-drug regimens Dovato and Juluca, and long-acting medications Apretude and Cabenuva, which together contributed nearly 60% to total HIV sales [4] - Sales of Dovato rose 23%, while Juluca fell 1%. Sales of Triumeq declined 10%, and Tivicay rose 2%. Apretude and Cabenuva saw significant increases of 95% and 40%, respectively [5] - Sales of the respiratory drug Nucala increased by 12%, and Benlysta sales rose by 16% due to strong demand across all regions [6] Oncology - Oncology sales surged by 94%, driven by demand for Jemperli, Ojjaara, and Zejula. Jemperli contributed £130 million, while Ojjaara generated £98 million in sales [7] General Medicines - Growth in General Medicines was primarily due to strong sales of asthma inhaler Trelegy Ellipta, which surged 16%. Sales of Anoro Ellipta, Advair/Seretide, and Revlar/Breo Ellipta also improved [9] Vaccine Sales - Vaccine sales declined mainly due to a 72% drop in RSV vaccine Arexvy sales, attributed to restrictive CDC recommendations. Shingrix sales fell 7%, partially offset by rising international sales [11] - Meningitis vaccine sales increased, with Bexsero and Menveo rising by 30% and 7%, respectively, while influenza vaccine sales fell by 22% [12] Operating Expenses - Core SG&A costs decreased by 2% to £2.07 billion, attributed to disciplined investments for global market expansion. Core R&D expenses rose by 3% to £1.43 billion due to continued investment in pipeline advancement [13] 2024 Guidance - Management expects overall revenues to increase by 7-9% at CER for the full year but has revised segment-level revenue guidance. Specialty Medicines are expected to grow in the high teens percentage at CER, while General Medicines are expected to see mid-single digit growth [14][15] - Vaccine sales are now expected to decline by a low-single digit percentage at CER, a revision from previous growth expectations [16] - Core operating profit is still expected to grow between 11% and 13% at CER, with core EPS growth projected at 10-12% at CER [17]