GSK NYSE: GSK reported what management described as a “strong” start to 2026, posting first-quarter sales growth and reiterating full-year guidance while highlighting momentum in specialty medicines, vaccines, and its long-acting HIV franchise. Executives also used the call to emphasize efforts to accelerate late-stage pipeline programs and to provide additional detail on key product launches and upcoming clinical milestones.
Quarterly performance and guidance
Luke Miels said first-quarter sales rose 5% to “more than GBP 7.6 billion,” driven by specialty medicines growth of 14% and higher vaccine sales, “particularly through strong Shingrix sales.” Core operating profit increased 10% and EPS was up 9%, while cash generation reached GBP 1.4 billion. The company declared a quarterly dividend of GBP 0.17.
Julie Brown said gross margin improved 110 basis points due to mix benefits from specialty medicines and Shingrix. SG&A declined 2% as reported, which she said was helped by positive IP settlements; on an underlying basis, SG&A grew 2%. Operating profit growth of 10% included legal settlements worth “3 percentage points,” she added. EPS growth reflected higher tax and finance expenses, partially offset by the share buyback.
Brown also confirmed GSK’s February full-year guidance and discussed phasing. She noted vaccines growth in Q1 benefited from U.S. stocking tied to the Shingrix pre-filled syringe, while from Q2 the company will begin to annualize publicly funded programs in Japan and certain EU countries. She said general medicines growth is expected to be weighted to the second half, and operating profit growth is also expected to be predominantly second-half weighted given productivity benefits and comparisons that include the prior-year RSV IP settlement in Q2.
Commercial highlights: Shingrix, oncology, respiratory, and Blenrep
Nina Mojas said commercial momentum continued, led by Shingrix and “strong growth for key products across our Specialty portfolio.” Specialty medicines grew 14%, while general medicines declined 6% due to the older established portfolio. Mojas said Trelegy’s performance did not offset the broader decline, citing limited U.S. growth from “increasing co-pay requirements due to Medicare redesign,” which she said are “especially pronounced in the first quarter” and expected to be less relevant later in the year.
Shingrix posted what Mojas called a record quarter, with sales of “more than GBP 1 billion,” up 20%. Europe drove much of the growth, with sales up 51% on uptake in national immunization programs and private demand. In the U.S., sales rose 12% and were influenced by inventory movements, including the new pre-filled syringe launch. Miels later provided additional detail, saying U.S. retail inventory rose to 2.4 million doses versus 1.7 million a year earlier, while wholesalers were “pretty steady.” Mojas said China demand is improving as doses administered increase, though GSK does not expect to see that improvement reflected in reported sales while existing stock at its partner is worked down.
In oncology, Mojas said Jemperli delivered GBP 232 million, up 40%, attributing demand to survival benefit in endometrial cancer. She pointed to a four-year RUBY follow-up showing “66% reduction in risk of death” in patients with dMMR, MSI-H endometrial cancer. She said pivotal results from AZUR-1 in rectal cancer are expected in the second half of the year.
GSK also discussed performance and launch progress for several respiratory and oncology products:
- Nucala: Mojas said Nucala continued double-digit growth following U.S. COPD expansion, with total brand new patient starts up 65% year over year and COPD market share at “around 45%.” She said early signals outside the U.S. have been strong, including in China, where GSK is “already capturing around 1 in 2 new patients.”
- Extencia: Mojas said U.S. access remains limited ahead of obtaining a J-code, expected in early July, after which she expects access to be “unrestricted.” She also said about 97% of patients prefer six-month dosing versus current options. In Q&A, Mojas attributed discontinuation of shorter-acting biologics in part to compliance challenges from dosing frequency, saying patients who discontinue “will usually go back to inhaled medicines.” Later in the call, she said about 70% of patients initiating Extencia so far have come from other biologics, and only about 20% of commercial U.S. patients currently have access, calling that “very normal in this therapy area” prior to a J-code.
- Blenrep: Mojas described Blenrep as “community-ready,” noting that 70% of multiple myeloma patients are treated in the community and that simple administration and safety are differentiators. She said U.S. prescribing is growing and that Blenrep has second-line approval in 19 markets, most recently China, with launches progressing in major markets including the U.K., Germany, and Japan.
HIV business: long-acting growth and pipeline timelines
Deborah Waterhouse reported HIV sales growth of 10%, driven by long-acting products and Dovato, with U.S. sales up 15%. She said Cabenuva grew 31% and Apretude grew 44%. Waterhouse emphasized ViiV’s focus on long-acting integrase inhibitor-based regimens, saying they represent more than 70% of HIV growth and more than one-third of total U.S. sales.
On development plans, Waterhouse said a phase III registrational study start for three-times-yearly Cabenuva is on track, with a planned 2028 launch. For three-times-yearly Apretude for PrEP, she said registrational study data are expected in the second half of 2026 and a launch in the first half of 2027.
Waterhouse also discussed longer-term goals for twice-yearly long-acting injectable treatment. She cited data for VH184 showing potential for twice-yearly dosing and an enhanced in vitro resistance profile versus Bic, and said VH499 also showed potential for twice-yearly dosing. In Q&A, she said the company cannot skip phase II development, noting, “The FDA will not allow us or anybody else actually to skip the phase II part of the development journey.” Later, she outlined a path to an “end of 2030 approval,” describing a phase II-A oral step already started for VH184, with VH499 phase II expected to start in the second half of the year and phase III targeted for 2028.
Addressing U.S. reimbursement, Waterhouse said Florida’s ADAP program changed formularies to restrict Biktarvy and Descovy, while a court case reversed a proposed reduction in eligibility thresholds. She said other states may look for efficiency measures, potentially including formulary changes, but she did not expect an overall reduction in access.
Pipeline and business development: hepatitis B, oncology ADCs, and acquisitions
Tony Wood said R&D is focused on accelerating development, noting seven phase III trials started in 2025 with 10 more starting in 2026. He highlighted late-stage investment in oncology antibody-drug conjugates (ADCs) and other assets, including Risrez (B7H3 ADC), Morez (B7H4 ADC), velzatinib for GIST, and efimosfermin alfa in MASH with pivotal studies recruiting well.
Wood also reviewed upcoming readouts in the second half of the year, including Jemperli in rectal cancer, camlipixant in refractory chronic cough, Exdensur in EGPA, and three-times-yearly PrEP data.
On chronic hepatitis B, Wood said GSK reported positive phase III “headline results” for bepirovirsen, with B-Well One and Two showing a “statistically significant and clinically meaningful increase in the rate of functional cure.” He said full data will be presented at EASL in May. Wood said regulatory reviews are progressing, with U.S. breakthrough designation and a PDUFA date of Oct. 26, plus priority review acceptance in China. In Q&A, management discussed the role of hepatitis B surface antigen levels in study selection and said it is assessing launch strategy in China alongside clearer approaches in the U.S. and Europe.
Wood also detailed early-stage oncology data for mocertatug rezetecan (a B7H4 ADC) in endometrial cancer and platinum-resistant ovarian cancer, including confirmed ORR figures at the highest doses and a planned start of five pivotal trials this year. He additionally cited partner-presented Risrez combination data in non-squamous NSCLC and plans for further studies, including a phase II combining Risrez with Jemperli.
On business development, Wood said GSK announced acquisitions of RAPT Therapeutics in food allergies and HS235 (from 35Pharma) in pulmonary hypertension. Brown said net debt was 1.4 times EBITDA and that shareholder returns totaled more than GBP 0.9 billion, with the share buyback expected to complete by mid-year. Brown also cited planned and completed portfolio actions, including a ViiV special dividend, the divestment of the Rockville manufacturing site, and out-licensing of linerixibat, which she said will positively impact net debt by $1.2 billion in the first half, including $400 million from linerixibat completed in Q2.
Management’s focus: accelerating execution and Q2 update
Miels said GSK is “completely focused on managing the business to drive top line growth and accelerate the pipeline.” In Q&A, he described a process of frequent leadership reviews of clinical execution and protocol decisions, with a goal of faster decision-making and resource allocation. He also said the company will provide a portfolio-focused update at Q2 results in July, including an HIV pipeline update instead of a separate HIV-only event.
About GSK NYSE: GSK
GSK (GlaxoSmithKline plc) is a London-headquartered, multinational pharmaceutical and healthcare company formed through the 2000 merger of Glaxo Wellcome and SmithKline Beecham. The company is dual-listed and operates globally, developing, manufacturing and commercializing prescription medicines, vaccines and specialty treatments. Over its history GSK has evolved through portfolio reshaping and strategic transactions to focus on science-led pharmaceuticals and vaccines.
GSK's core activities include research and development of therapies and vaccines across a range of therapeutic areas, commercial manufacturing, and global marketing.
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