GSK Targets £1.9B Savings to Fuel Pipeline, Navigate HIV Patent Cliff

GSK NYSE: GSK is accelerating investment in research and development, expanding its late-stage pipeline and targeting cost savings to support product launches while maintaining profitability through upcoming HIV patent expirations, Chief Financial Officer Julie Brown said during a company discussion.

Brown said CEO Luke, who took the role at the beginning of the year, has focused the company on three priorities: accelerating R&D, funding launches and simplifying operations. GSK formed a Strategic Portfolio Review Group that meets every two weeks with program leaders to assess how priority assets can move faster through development, she said.

In parallel, GSK examined ways to simplify its business using technology and artificial intelligence. The work resulted in a change program announced at the end of July targeting nearly £1.9 billion in savings, with most of those savings intended for reinvestment in the pipeline.

“It means that we have got 20 phase III starts this year from 10,” Brown said, adding that the starts span seven assets and about 18 indications. GSK plans to allow some savings to support margins during the 2028-2030 period when HIV drug dolutegravir loses patent protection. Brown said the company now expects margins during that period to be stable to improving.

R&D ecosystem and business development

GSK is moving its U.K.-based R&D operations from Stevenage to Cambridge, U.K., seeking to benefit from a biotechnology ecosystem that includes Addenbrooke’s Hospital, the University of Cambridge and more than 400 biotech organizations, Brown said. The company expects closer access to hospitals, academic researchers and biotech companies to shorten the path from research to translational medicine and clinical development.

Brown also identified the U.K., the U.S. East Coast, California and China as important locations for business-development activity. In China, GSK has established collaborations with Hengrui in respiratory medicine and Hansoh in oncology. Brown said the companies retain rights in China while GSK holds rights in other markets, allowing them to generate data in different patient populations in parallel.

HIV transition and patent strategy

Brown said GSK is pursuing longer-acting HIV therapies because patients prefer them to daily oral tablets and because they may help reduce the risk associated with missed doses. The company currently markets two-month injectable treatments and expects a final readout for a four-month treatment regimen in 2027, followed by a planned launch in 2028. GSK is also developing a six-month treatment option.

According to Brown, 90% of patients in GSK’s SOLAR study preferred long-acting injectables to oral therapies. She said more than 30% of GSK’s U.S. HIV business has already shifted to long-acting injectables.

GSK’s current treatment combination includes CABENUVA and rilpivirine. Brown said the new chemical entity patent for CABENUVA expires in 2031, but GSK has patent applications pending that could extend protection for combinations into 2035 and potentially the 2040s. Newer six-month assets, VH-184 and VH-499, would carry new patent estates, she said.

Clinic capacity for administering injections remains a constraint in the U.S., Brown said. However, moving patients from two-month to four-month dosing could effectively double available treatment capacity. She added that longer-acting HIV products remain profitable, though the current CABENUVA-rilpivirine combination has some gross-margin pressure due to payments to Janssen for rilpivirine.

Oncology pipeline and Nuvalent acquisition

Brown said GSK’s acquisition of precision-oncology company Nuvalent, valued at more than $10 billion, brought two late-stage assets and an earlier-stage program. She said zidesamtinib, for ALK and ROS1 non-small cell lung cancer, was approved by the U.S. Food and Drug Administration in July ahead of its expected decision date. Neladalkib has a PDUFA date in November, she said.

Brown said the drugs are designed to target tumor-driving genes while improving tolerability compared with certain existing treatments. She also highlighted GSK’s marketed multiple myeloma therapy BLENREP, as well as antibody-drug conjugate candidates B7-H4 for gynecological cancers and B7-H3 for small cell lung cancer and prostate cancer.

B7-H3 could become “a pipeline within a product” because it may be studied across multiple tumor types, Brown said. She also cited velzatinib for gastrointestinal stromal tumors as another development opportunity.

Vaccines, respiratory and liver disease

For shingles vaccine SHINGRIX, Brown said U.S. penetration has reached about 45% and is increasing by an expected two to four percentage points annually. Penetration across 12 major markets outside the U.S. was about 12%, she said, highlighting room for international expansion. GSK has guided to SHINGRIX becoming a more than £4 billion asset.

GSK has also initiated a major trial evaluating SHINGRIX’s potential effect on major adverse cardiovascular events. Brown said observational work indicated a possible 30% to 40% reduction in the risk of such events, though the company will need successful trial results for a potential FDA label expansion.

In respiratory medicine, Brown highlighted Exdensur, formerly called depemokimab, a six-month IL-5 treatment for severe asthma. She said the product showed a 72% reduction in exacerbations resulting in hospitalization and received a U.S. J-code recently, supporting reimbursement.

Brown also discussed bepirovirsen for hepatitis B, saying the therapy had received fast-track designations in major markets and approval in Japan. She said GSK’s data showed 19% of patients achieved a functional cure after six months of treatment, while additional patients experienced reduced surface antigen levels.

On acquisitions, Brown said GSK intends to maintain a strong investment-grade balance sheet while continuing to source internal and external innovation. She said the Nuvalent transaction brought leverage to just under two times net debt to EBITDA, while GSK expects the deal to be immediately sales accretive, operating-profit accretive next year and earnings-per-share accretive in 2029.

About GSK (NYSE:GSK)

GSK plc is a global biopharmaceutical company headquartered in Brentford, England. The company researches, develops and manufactures medicines and vaccines for the prevention and treatment of disease, serving patients and healthcare providers in markets around the world.

GSK focuses on specialty medicines and vaccines in areas including infectious diseases, HIV, respiratory disease, immunology and oncology. Its products include prescription medicines, long-acting treatments and vaccines designed to protect against diseases such as shingles, meningitis, influenza and respiratory syncytial virus (RSV).

The company was formed in 2000 through the merger of Glaxo Wellcome and SmithKline Beecham.

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