GSK PLC Earnings - Q4 2025 Analysis & Highlights

GSK reported strong 2025 results with 7% sales growth to £32 billion, driven by specialty medicines and vaccines, while guiding for continued profitable growth in 2026 with focus on pipeline acceleration, long-acting HIV regimens, and strategic business development to address dolutegravir loss of exclusivity and drive the £40 billion revenue target.

Key Financial Results

Sales grew 7% to more than £32 billion in 2025.

Core operating profit grew 11% and EPS was up 12% in 2025.

Cash generation was strong at £8.9 billion, supporting future investment and shareholder returns.

Dividend upgraded by £0.02 to £0.66 declared for 2025.

Operating margin increased 110 basis points in 2025, bringing total accretion at constant exchange rates to 470 basis points over the last four years.

Gross margin benefited 40 basis points from portfolio transition towards specialty medicines.

Cash generated from operations was £8.9 billion or more than £10 billion excluding Zantac payments, up £1.6 billion year-on-year.

Free cash flow increased to £4 billion or more than £5 billion excluding Zantac.

Zantac payments in 2025 were £1.2 billion, with £1.9 billion paid in total, materially completing the settlement process.

Business Segment Results

Specialty Medicines grew 17%, driving overall sales growth.

Respiratory, Immunology & Inflammation full-year sales were up 18% driven by strong Benlysta and Nucala performance.

Benlysta grew 22% driven by higher demand and supported by all major guidelines, with 82% of US bio naïve patients now starting on Benlysta.

Nucala grew 15% and delivered £2 billion for the year, marking the 10th consecutive year of double-digit growth.

Oncology sales were up 43%, with Jemperli sales up 89% reflecting differentiated profile in endometrial cancer.

Ojjaara grew 60% driven by growth in all markets following new data at EHA.

Zejula sales decreased, reflecting FDA labeling restrictions.

HIV sales growth was 11% powered by accelerated patient demand for long-acting injectables and foundational oral 2 drug regimen Dovato.

US HIV market grew 14% in 2025, continuing to outpace competition in market share gain.

Over 75% of HIV growth came from long-acting injectables, which now represent around a third of US sales.

Cabenuva grew 42% in 2025, reaching more than 75% market share in the US this quarter.

Apretude grew 62% in 2025 withstanding impact from competitor launch.

Vaccines sales were £9.2 billion, up 2% driven by European and international region sales of Shingrix and Bexsero.

Shingrix sales were £3.6 billion, up 8%, driven by Europe and international region, offset by the US.

Meningitis sales were up 12% with strong continuous growth across Europe and international driven primarily by Bexsero, up 16% for the year.

Bexsero ex-US represents 69% of global full-year sales, demonstrating continued growth from national immunization programs and geographic expansion.

GenMed sales were slightly down for the year, with strong growth of Trelegy offset by other respiratory and established products.

Capital Allocation

Shareholder distributions totaled £4 billion through dividend and share buyback.

93 million shares repurchased at an average price of £14.73, with remaining £0.6 billion to be completed in half one.

£4.5 billion deployed in CapEx and BD, adding three potentially best-in-class clinical stage specialty assets to the pipeline and completing multiple early stage and platform deals.

Net debt to EBITDA relatively stable year-on-year at 1.3 times, including absorption of Zantac and the buyback.

Dividend of £0.70 expected to be paid, a 6% increase.

Industry Trends and Dynamics

COPD is a growing area of significant unmet need, with patients hospitalized with exacerbation having less than a 50% chance of survival over a five-year period and cost to US healthcare of around $7 billion per year.

Treatment accounts for 90% of the total $22 billion HIV market.

Only 27% of US eligible patients are on a biologic for severe asthma, indicating significant opportunity in the bio naïve population.

97% of patients would prefer or likely switch to a biologic with six monthly dosing.

Food allergy is a chronic inflammatory condition with severe reactions leading to anaphylaxis, emergency care, and persistent lifestyle disruption.

In the US, severe food allergies impact over 17 million patients with an estimated $33 billion cost of economic burden.

Chronic hepatitis B affects more than 250 million people worldwide causing over 1 million deaths each year.

Chronic hepatitis B accounts for around 56% of liver cancer cases, and real-world evidence shows that functional cure reduces this risk by around 90%.

Competitive Landscape

GSK maintains the only commercially established long-acting HIV treatment regimen backed by over four years of real world data.

Nucala COPD launch in the US is going very well, with 43% to 46% of new patient starts already achieved.

In the US, GSK retains MenB market leadership with 74% market share and has seen positive signs for Penmenvy with initial stock building.

Globally, Trelegy continues to be the top-selling brand for asthma and COPD.

In the US, the SITT class is growing with Trelegy leading in share driven by GOLD guidelines and strong execution.

Apretude has not been dented by the launch of Yeztugo, continuing to grow.

Blenrep is the off-the-shelf BCMA agent for multiple myeloma available in the community setting where 70% of patients are treated.

Macroeconomic Environment

Currency was a headwind to margin, lowering the reported margin to 29.9% for the year.

If rates hold at the closing rates on the 28th of January, GSK would expect an impact of minus 3% on sales and minus 6% on operating profit.

GSK navigated the impact of the Medicare Redesign from the Inflation Reduction Act near the upper end of £400 million to £500 million range.

Insurance coverage for pediatric vaccines remains as before, and GSK expects recent HHS changes to be manageable given its broad portfolio of vaccines.

Growth Opportunities and Strategies

R&D output remained very positive with five FDA approvals and seven new pivotal trial starts in 2025.

GSK secured five FDA regulatory approvals and started seven new pivotal trials in 2025, including three for Exdensur in COPD, two for efimosfermin in MASH, one for velzatinib in second-line GIST, and ris-rez, the B7-H3 ADC in extensive stage small cell lung cancer.

Exdensur demonstrated a 72% reduction in exacerbations leading to hospitalizations in an indication where lack of therapy adherence leads to worse clinical outcomes.

GSK expects Exdensur to be a slow ramp-up as it supports prescribers and patients to ensure a positive first experience and robust adoption.

Blenrep is now approved in 15 markets globally.

GSK has engaged around 18,000 eye care professionals in the US, enabling smooth collaboration between treating physicians and eye care professionals.

Efimosfermin is a potential best-in-class once-monthly FGF21 analog which started Phase III trials for MASH last year.

In Phase II, efi demonstrated sustained improvement in fibrosis and resolution of MASH in patients with F2, F3 stage disease.

GSK plans to start the NEBULA Phase III studies, which will recruit a more advanced F4 patient population later this year.

GSK '990 is an siRNA therapeutic targeting HSD17B13, with preliminary data from Phase II STARLIGHT study in alcoholic liver disease demonstrating favorable trends in reduced liver enzymes despite ongoing alcohol consumption.

Bepirovirsen showed positive results from B-WELL 1 and B-WELL 2 studies, Phase III trials for chronic hepatitis B treatment.

GSK believes bepi has the potential to transform chronic hepatitis B treatment and become the first ever fixed course of therapy with functional cure at a significantly higher rate than today's standard of care.

GSK anticipates mature OS data from DREAMM-7 in early 2028 to support second-line registration in the US for Blenrep.

DREAMM-10 is recruiting well for Blenrep in the first-line transplant-ineligible setting, with interim MRD and safety data expected in early 2028.

Velzatinib, the KIT inhibitor, has started Phase III in second-line GIST with first-line to start later this year.

Velzatinib has the potential to replace current standard of care and is designed to offer a well-tolerated schedule with greater efficacy against resistant mutations.

Ris-rez recently received its fifth regulatory designation with orphan drug status in SCLC.

GSK has initiated a global program encompassing multiple solid tumor trials for ris-rez called EMBOLD.

Mo-rez is GSK's B7-H4 ADC in platinum-resistant ovarian cancer and in patients with recurrent endometrial cancer.

GSK announced an agreement to acquire RAPT Therapeutics whose lead asset is ozureprubart, a potential best-in-class long-acting anti-IgE monoclonal for food allergy, currently in Phase II.

GSK expects the RAPT deal to close this quarter and looks forward to progressing this important asset into Phase III development.

GSK has critical data readouts to come for bepi, camli, Jemperli, Q4M PrEP, and Exdensur for EGPA.

GSK has 10 pivotal starts planned for this year, including more than 5 from ADCs, 2 for advanced MASH and CUATRO, the Q4M treatment Phase III trial for HIV.

VH184 is a potential first-in-class, third generation INSTI with IP protection through to at least 2040.

GSK will present key data on VH184's unique resistance profile versus the competitor and findings from an ongoing first-time-in-human trial exploring its significant potential for up to twice yearly dosing.

GSK strongly believes VH184 has the power to redefine the long-acting landscape.

GSK is evaluating two partners with VH184 INSTI once selected: VH499 and the bNAb, N6LS.

For N6LS, one of the broadest and most potent bNAbs in development, GSK will share more data focused on Q4M dosing with Q6M dosing data expected this year.

GSK will begin CUATRO, the Phase III registrational study for four monthly HIV treatment this year.

GSK is on track to file in 2027 and launch in 2028 for Q4M HIV treatment.

At launch, GSK still expects to have the only long-acting treatment options on the market for years to come.

GSK achieved last patient, first visit for the CALM-2 study in December for camlipixant in refractory chronic cough.

GSK is on track to report Phase III data from the total camlipixant program around mid-2026.

GSK believes camlipixant will provide an effective treatment in RCC where there are no approved therapies in the US.

Approximately 10 million patients diagnosed globally could benefit from camlipixant.

GSK expects sales to grow low-double digit for 2026 in Specialty.

GSK expects continued growth momentum in HIV in 2026, guiding mid- to high-single-digit growth.

GSK expects market performance outside of the US and China to benefit Shingrix sales, offset by slowing US immunization rates and partner in China managing inventory.

GSK expects sales growth for Vaccines to be in the range of low-single-digit decline to stable for 2026.

GSK expects sales growth for GenMed to be in the range of low-single-digit decline to stable for 2026, reflecting pricing pressures and generic competition.

GSK is applying lessons from the severe asthma market with Nucala to the launch of Exdensur.

GSK made fast progress on Blenrep launch in the UK and is applying lessons learned in the US, particularly around eye care networks.

GSK is taking a targeted approach to align access to Blujepa in uncomplicated UTIs with positive initial insights.

GSK now has a PDUFA date of 18th June for tebipenem in the US for complicated UTIs.

GSK's strategy is to focus on execution and operational delivery to drive top line growth by maximizing launched products like Blenrep and Exdensur.

GSK is accelerating key assets in late-stage portfolio like B7-H3, B7-H4 and velzatinib in oncology and efi in MASH.

GSK is accelerating earlier portfolio assets like the ultra-long-acting TSLP for respiratory diseases and regimen selection for six-monthly treatment for HIV.

GSK will continue to execute business development where it sees a clear pathway to value creation.

GSK is driving to simplify how it works with greater pace, accountability, and focus.

GSK is matching best people and resources to best opportunities to create value.

Changes have been made to the executive team, bringing on commercial leaders with deep industry experience to increase focus on products and execution.

GSK will have an increased focus on leveraging practical use of AI and technology.

GSK's top priority is to accelerate development to deliver new products to patients faster.