GSK Reports Q3 2024 Results: Vaccine Revenue Down 15%, Strong Offsets from Oncology and HIV Segments

Oct 30, 2024 18:12 CST Updated 18:12

GSK

Pharmaceutical R&D Manufacturer

丨Compiled by the PharmaHunter Club Research Team

On October 30, GSK(GSK) Released the Financial Results for Q3 2024, with Revenue Reaching£8.012 billion(approximately USD 10.496 billion), year-on-year growth2%(Calculated at fixed exchange rates, same below)。First three quartersSales amount to£23.259 billion（Approximately USD 30.469 billion）, year-on-year growth8%. Among them,Vaccine SalesDecreased by 15%, while the sales of specialty drugs (including oncology, HIV, respiratory/immunology segments) and general drugs were respectivelyIncreased by 19%And 7%。

Affected by allegations related to the Zantac lawsuit(WithZantacThe costs related to the settlement amounted to £1.8 billion., GSK's total operating profit fell by 86%. However, the forecast was reiterated:Full-year revenue growth is expected to be 7% to 9%, core operating profit growth 11% to 13%, and core earnings per share growth 10% to 12%.

In addition,Due to weak demand for respiratory syncytial virus (RSV) and shingles vaccines, the company cut its 2024 vaccine sales forecast for the second time this year on Wednesday.。Vaccine Sales to Decrease by Low Single-Digit Percentage in 2024Previously, the company expected this business to grow by a low to mid-single-digit percentage.

Key Product Revenue

Vaccine Business:

GSK Vaccine Business Revenue in Q3 2024£2.65 billion, year-on-yearDecrease by 15%。Among them:

1) Shingrix, the herpes zoster vaccineRevenue of £7.39 billion,Decrease7%；RSV Vaccine ArexvyRevenue of £188 million,Down by 72%. Reflects changes in the ACIP guidelines, adjustments to the U.S. COVID vaccination prioritization, and factors making Arexvy's Q3 2023 launch difficult to compare.

2) MeningitisTwo vaccines, Bexsero、MenveoAn increase of 30% and 7% respectively, achieving revenues of £3.34 billion and £1.73 billion respectively.

Specialty Drugs

Specialty Pharmaceuticals Business Q3 Revenue£2.966 billion, year-on-year growth19%. Among them:

1) AIDS SectorRevenue£1.75 billion, year-on-year growth12%。

2) Tumor SectionIncome£373 million, year-on-year growth94%。

3) Respiratory/Immune System and Other SegmentsRevenue£8.43 billion, year-on-year growth14%。

Oncology drugs achieve strong growth, with key drivers including:

Medications for Anemia in Myelofibrosis PatientsOjjaara （momelotinib）, is a potent, selective, and orally bioavailable JAK1, JAK2, ACVR1/ALK2 inhibitor. It was launched in the United States in the third quarter of 2023, in the United Kingdom and Germany in the first quarter of 2024, and in Japan in the third quarter of 2024. Since its launch, sales have been strong,Achieved £98 million in revenue in Q3 2024。

Jemperli（Dostarlimab）It is a PD-1 monoclonal antibody that has been approved for marketing in the EU and the United States. The approved indications include endometrial cancer, colorectal cancer, and recurrent or advanced solid tumors with mismatch repair deficiency (dMMR).Achieved £130 million in revenue in Q3 2024, mainly driven by the newly approved indication for endometrial cancer.

The performance of the HIV segment was driven by strong sales of the LAI long-acting injectable portfolio (Cabenuva, Apretude) and Dovato:

Long-Acting Injectables Cabenuva and Apretude Generate Revenue of £314 Million, accounting for 50% of the total growth this quarter. Among them, Cabenuva sales reached 245 million pounds, increasing by 40% compared to the third quarter of 2023;Apretude Sales Reach £69 Million, Up 95% from Q3 2023.
Dovato Sales Reach £567 Million, becoming the leading oral two-drug regimen (2DR）。

Key Product Progress in 2024 Q3

Infectious Diseases Section：1）Arexvy1) Approved in the EU for high-risk adults aged 50-59, new positive data shows that the drug has a protective effect across three RSV seasons; 2) The US FDA accepted the marketing application for gepotidacin for the treatment of uncomplicated UTI; 3) The small nucleic acid drug bepirovirsen for hepatitis B received SENKU designation in Japan for the treatment of chronic hepatitis B.

HIV/AIDS Section:Real-world studies show that,ApretudeThe effective rate is 99%., is the only long-acting drug approved for HIV prevention.

Respiratory/Immunology Sector:1）Announced positive results from the Phase III ANCHOR trial (CRSwNP) for the ultra-long-acting biologic depemokimab, along with full positive results from the SWIFT-1 & 2 trials (severe asthma), supporting applications for dual indications of severe asthma and CRSwNP by the end of the year, with an expected launch in 2025.。2）AnnouncementNucalaPositive Results from MATINEE Phase III Trial for the Treatment of Chronic Obstructive Pulmonary Disease. In addition, Japan has approvedNucalaFor CRSwNP.

Oncology:1）JemperliTreatment for endometrial cancer receives expanded approval from the U.S. FDA; 2)BlenrepApplication for Breakthrough Therapy Designation in the United States, the European Union, and Japan, and receipt of such designation in China; 3)GSK5764227 (B7-H3 Targeted ADC) Receives FDA Breakthrough Therapy Designation for Small Cell Lung Cancer Treatment.

2025: Expected Approval of 5 Core New Products/Indications

GSKPlan for next year is expected to have5A core new product/indication will be approved.：Blenrep、Depemokimab, for the treatment of chronic obstructive pulmonary disease Nucala、Gepotidacin AndFive-in-One Vaccine for Meningitis Prevention (MenABCWY）。

Blenrep: Potential Global First Approved Therapy Targeting BCMA

BlenrepIs a targetedBCMAOfADC, by humanized anti-BCMAMonoclonal Antibodies and Cytotoxic DrugsAurestatinF（auristatin F) Coupled through a non-cleavable linker, which can eliminate myeloma cells through multiple mechanisms of action.The drug was2017Year obtained in the United StatesFDAGranted Breakthrough Therapy Designation, and on2020Year8Month obtainedFDAAccelerated Approval, treatment for those who have previously received at least4Recurrence of this therapy/Patients with refractory multiple myeloma.According toGSKPress release, this willIs the world's first approved targetedBCMATherapy.

This Year6Month,GSKPublishBlenrepTwo Phase 3 TrialsDREAMM-7AndDREAMM-8The results of the study.Among them,DREAMM-7EvaluatedBlenrepBortezomib plus dexamethasone (BorDex) in combination with the current standard treatment regimen (DaratumumabAddBorDex) In comparison, asRRMMPatient2Efficacy in subsequent treatments.

The analysis shows,AcceptBlenrepPatients receiving combination therapy (N=243) Median Progression-Free Survival (PFS) for36.6months, compared with the active control group (N=251) of13.4More than a month2Year, AcceptBlenrepThe risk of disease progression or death in patients receiving combination therapy was reduced by nearly60%, achieving the primary endpoint of the trial.

Depemokimab: Twice a Year, Poised to Become the First Ultra-Long-Acting Biologic for Severe Asthma

DepemokimabYesGSKDeveloped a new generationIL-5Monoclonal antibody, also the first to enterIIIThe ultra-long-acting biologic agent has a longer half-life, high binding affinity, and high potency.IL-5Yes2Type inflammationThe key cytokines.Exceed80%The condition of patients with severe asthma is caused by2Type inflammation is caused by, patients have the characteristic of elevated eosinophil levels, and their condition deterioration is unpredictable.DepemokimabThe long half-life and for IL-5 Its high affinity allows it to be administered once every six months for the treatment of severe asthma patients.

2024Year5Month22Day,The company announcedDepemokimabIn two key3Positive results in the clinical trial phase.These two items are namedSWIFT-1AndSWIFT-2The trials have all achieved significant efficacy, markingDepemokimabIn the treatment of2A significant breakthrough has been made in adult and adolescent patients with severe asthma characterized by type inflammation.

Nucala (mepolizumab): The world's first approved biologic therapy targeting IL-5, expected to be approved for COPD next year

NucalaIn2015First approved in the United States in [Year] for the treatment of severe asthma with an eosinophilic phenotype.It is a targetedIL-5Monoclonal antibodies have been developed for the treatment of a series of conditions related to2Type inflammation-relatedIL-5Mediate diseases.2024Year9Month7Day,GSKAnnouncementNucala（mepolizumab) in the treatment of adult chronic obstructive pulmonary disease (COPD) Patient's3Phase Clinical TrialMATINEEPositive results obtained in China.This trial result will supportGSKDiscuss with regulatory authorities to submit an application for extensionNucalaIndications.

Gepotidacin: The First Novel Oral Antibiotic for the Treatment of uUTI in Over 20 Years

GepotidacinIt is an antibiotic with a novel mechanism of action, which can be taken orally and has a dual mechanism of action, selectively binding to and inhibiting simultaneously.DNAGyrase andDNATopoisomeraseIV, thereby inducing in the replication processDNASingle-strand breaks occur, thereby achieving the purpose of killing pathogens.

2024Year10Month17Day，GSKAnnouncement, United StatesFDAHas accepted its potential"first-in-class"Oral AntibioticsgepotidacinNew Drug Application (NDA), used for the treatment of patients with simple urinary tract infections (uUTI, also known as acute cystitis) in adults or adolescents (≥12Years)FemalePatient, patient's weight must be ≥40Kilogram.FDAThe application has been granted priority review status and is expected to be approved by2025Year3Month26Recently completed the review.According to the press release, if approved,gepotidacinWill become20The first treatment in years foruUTIA new type of oral antibiotic drug.

MenABCWY: The First 5-in-1 Meningococcal Vaccine

MenABCWYCombined withBexsero（MenB）、Menveo（MenACWY) antigen, while targetingABCWYFive serotypes.These five serotypes account for nearly all invasive meningococcal disease cases, and so far, there is no vaccine that can provide protection against all five serotypes simultaneously.

2023Year3Month14Day,GlaxoSmithKline PLC.AnnouncementMenABCWYThe pentavalent meningococcal vaccine met all endpoints in Phase III clinical trials.11A major endpoint, and achieved withBexsero、MenveoConsistent safety data.

This Year 4 Mid-month,FDA Accepted GSK The 5 Combine 1 Meningococcal Vaccine ABWY (MenABCWY) The BLA Application,PDUFA Date: 2025 Year 2 Month 14 Day.

References

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