Text: May Editor: Vitamin
On July 31, 2024, GlaxoSmithKline (GSK) released its semi-annual report. The sales revenue for the second quarter of 2024 was £7.884 billion (approximately $10.09 billion, calculated at the current exchange rate of £1 = $1.28), representing a year-on-year increase of 13% (at constant exchange rates). For the first half of 2024, total revenue reached £15.247 billion (approximately $19.516 billion), marking a year-on-year growth of 12% (Figure 1).[1]。Vaccine sales increased by 1%, or 3% excluding the impact of COVID-19 products. Specialty medicine sales grew by 22%, HIV product line sales increased by 13%, and oncology...ProductSales more than doubled to £400 million ($512 million), with generic drug sales up 12%.Figure 1. GSK's Revenue in the First Half of the YearThe Core Growth Driver of GSK's Performance:
Vaccine Business
Excluding the impact of COVID-19 products, GSK's vaccine business sales revenue grew 3% year-on-year to £1.999 billion (£2.559 billion) in Q2 2024.In H1 2024, GSK's vaccine business sales increased by 12% year-over-year to £4.276 billion ($5.473 billion), accounting for 28% of GSK's total revenue., mainly driven by meningitis vaccines, Shingrix (outside the United States), and Arexvy for Respiratory Syncytial Virus (RSV) (Figure 2).[1，2]。Figure 2.GSK's Vaccine Revenue in the First Half of the Year
Shingrix is GSK's重磅 vaccine product, a recombinant subunit vaccine comprised of the antigen glycoprotein E (gE) and the AS01B adjuvant system.
Shingrix was successively approved for marketing in the U.S. in October 2017 and in China in May 2019, for the prevention of shingles and its complications in elderly people aged 50 years and above.But ShingrixAt the BeginningThe sales of the vaccine in China have not been ideal, with a low vaccination rate. This may be related to its high price, being a Category II vaccine (fully self-funded), and the public's insufficient understanding of shingles, as well as the lack of awareness among middle-aged and elderly people about the importance of vaccination.In October last year, GSK announced an exclusive cooperation agreement with ZF Bio, mainly on the supply, distribution, and co-promotion of GSK's recombinant shingles vaccine Shingrix.GSK will designate Chongqing Zhifei Biological Products Co., Ltd. as the exclusive importer and distributor in the cooperation region. The agreement has an initial term of three years and is expected to be renewed upon mutual agreement.
Previously, Zhifei Biological and Merck achieved excellent results in vaccine cooperation and promotion, especially with the HPV vaccine. It is believed that this cooperation agreement with GSK will significantly improve the accessibility of Shingrix in China.Starting from January 1, 2024, Zhifei Biological Products will hold the exclusive import and distribution rights for Shingrix in China, promoting Shingrix through its marketing network that spans over 30,000 vaccination sites across the country.Arexvy is a bivalent RSV vaccine developed by GSK, containing the recombinant prefusion conformation of the RSV F glycoprotein antigen (RSVPreF3) and GSK's proprietary adjuvant AS01E.
On May 3, 2023, GSK announced that the FDA had approved Arexvy for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) infection in individuals aged 60 years and older.Arexvy is the world's first RSV vaccine approved for use in the elderly.This approval is based on the positive results of GSK's landmark AReSVi-006 (Adult Respiratory Syncytial Virus) pivotal Phase III trial.In the trial, the vaccine showed 82.6% efficacy against RSV-LRTD in adults aged 60 years and older, with significant statistical and clinical significance (96.95% CI, 57.9-94.1, 7/12,466 individuals (vaccine group) vs. 40/12,494 individuals (placebo group)), achieving the primary endpoint of the clinical trial.[3]。In the first half of this year, the AReSVi-004 trial showed positive results in terms of immunogenicity, safety, reactogenicity, and persistence of a single dose of Arexvy in adults aged ≥60 years under different re-vaccination schedules, as well as evaluating long-term protection up to 2 years after Arexvy vaccination (Figure 3).
Figure 3. Arexvy Still Provides Protection Two Years After Vaccination
Arexvy, as the world's first RSV vaccine, achieved sales of £709 million (£907 million) in its first quarter on the market. In 2023, sales reached £1.238 billion ($1.585 billion), surpassing $1 billion in its first year to become a blockbuster drug. In the first half of this year, sales reached £244 million ($312 million).
However, in June this year, the US Centers for Disease Control and Prevention adjusted the recommendation for RSV vaccination: changing the recommended population from elderly people over 60 years old to adults aged 75 and above, as well as high-risk groups aged 60-74.
This adjustment poses a considerable challenge to the RSV market as well as GSK's Arexvy, with an uncertain outlook for Arexvy's future performance.
$70 Billion Boost for Innovative Drugs
GSK has a history of 50 years in the respiratory drug field. According to GSK's 2024H1 report, revenue from the respiratory field reached £1.546 billion ($1.979 billion), representing an 18% year-over-year increase.GSK has successively developed respiratory drugs such as Nucala (mepolizumab) for severe asthma, and Advair and Trelegy for asthma/chronic obstructive pulmonary disease (COPD).Nucala is an anti-IL-5 antibody developed by GSK. It can selectively recognize and bind to IL-5, blocking the binding of IL-5 to the surface receptors of eosinophils, inhibiting the biological activity of eosinophils and continuously reducing their numbers to normal levels, thereby decreasing inflammation and tissue damage mediated by eosinophils.
Nucala was approved by the FDA for marketing in November 2015. It is the world's first anti-IL5 monoclonal antibody for the treatment of eosinophilic asthma and the first targeted drug for the treatment of eosinophilic granulomatosis with polyangiitis.Since its launch, Nucala's sales have continued to grow. The sales in the first quarter of 2024 were £374 million ($479 million), and in the second quarter, they reached £482 million ($617 million). The total sales in the first half of the year amounted to £856 million ($1.096 billion), representing a 15% year-on-year increase.Advair, a classic drug from GSK for the treatment of asthma and COPD, has ranked among the top 10 global best-selling drugs for many years.However, due to generic drugs and other competing medications, the sales of Advair have been declining. In 2018, its global sales were $2.422 billion, representing a 21% decrease from 2017.Among them, the sales revenue in the U.S. market was US$1.097 billion, a 30% decrease compared to 2017. The sales revenue in 2019 was US$2.297 billion, and the sales revenue in 2021 was US$1.866 billion.
Trelegy is the most prescribed single inhaler triple therapy (SITT) treatment for chronic obstructive pulmonary disease and asthma globally.Sales in the first quarter of 2024 were £591 million ($756 million), a year-on-year increase of 33%. Sales in the second quarter reached £800 million ($1.024 billion), a year-on-year increase of 41%. Thus, the total sales in the first half of the year amounted to £1.391 billion ($1.78 billion), showing rapid growth.
GSK and Flagship Reach CollaborationGSK Continues to Deepen its Focus on Respiratory Field: On July 29, GSK and Flagship Pioneering, a bioplatform innovation company, announced that they had reached a cooperation agreement aimed at discovering and developing a series of transformative drugs and vaccines for the future, starting with respiratory and immunology.
The alliance combines GSK's expertise and development capabilities in disease areas with Flagship's ecosystem of bioplatform companies, including its novel modalities and technologies, to achieve significant advancements in healthcare.GSK and Flagship will initially provide up to $150 million in upfront funding to support the exploration phase, aimed at identifying the most promising concepts for further research and development with Flagship’s bioplatform companies. Through these explorations, the collaboration aims to establish a portfolio of up to 10 novel drugs and vaccines, each of which will be exclusively optioned by GSK for further clinical development.Under the terms of the agreement, GSK will provide an upfront payment of $720 million, R&D and commercial milestone payments, as well as preclinical funding support and a specific percentage of sales royalties for each drug, with the total amount expected to exceed $7 billion.HIV/AIDS Field
GSK Secures the Second Spot
Apart from Gilead, GSK has also achieved significant success in the HIV field, with HIV drug sales increasing by 13% to £1.757 billion (£22.49 billion) in Q2 2024. In H1 2024, HIV drug sales rose by 14% year-on-year to £3.37 billion (£43.14 billion) (Figure 4).Figure 4. GSK Revenue in the First Half of 2024
GSK Approved the World's First AIDS Drug, Zidovudine, in 1987; In December 2015, ViiV Healthcare, a Subsidiary of GSK, Announced a Package Acquisition of All BMS's HIV Drugs in Development for Approximately $1.455 Billion, Further Expanding Its R&D Pipeline.Currently, GSK has several blockbuster HIV drugs, including Dolutegravir products, Dovato, Tivicay, Triumeq, and Cabenuva (Figure 5).Figure 5. Sales of GSK's Major HIV DrugsDolutegravir products, developed by GSK, are the first-line and second-line drugs of choice for treating AIDS. They are suitable for pregnant women and women of childbearing age and represent GSK's best-selling AIDS medication. In the first quarter of this year, sales reached £1.304 billion ($1.669 billion), with second-quarter sales at £1.391 billion ($1.78 billion). The total sales in the first half of the year amounted to £2.695 billion ($3.45 billion).
Triumeq, ViiV Healthcare's first fixed-dose combination drug based on Dolutegravir, consists of Abacavir 600mg, Dolutegravir 50mg, and Lamivudine 300mg. It offers many HIV patients the option of a single-tablet regimen. It was approved for marketing in the United States in August 2014. From the second year after its launch to 2022, Triumeq’s sales basically ranked among the top three. In 2023, it was surpassed by another HIV drug from GSK, Dovato. In the first half of this year, Triumeq's sales reached 656 million pounds (840 million US dollars).
Dovato is a complete, once-daily, single-tablet, two-drug regimen (2DR) consisting of a fixed dose of Dolutegravir (DTG, 50mg) and Lamivudine (3TC, 300mg).
In April 2019, Dovato was launched in the U.S. for the first time, indicated for adult patients with HIV-1 who have not received prior antiretroviral (ARV) therapy and have no known resistance to DTG or 3TC.Becomes the first dual-drug fixed-dose complete therapy approved by the FDA for this indication.Since its launch, Dovato has performed exceptionally well with steadily increasing sales. In the first quarter of this year, sales reached £483 million ($618 million), a 27% increase year-over-year at constant exchange rates. Sales in the second quarter amounted to £551 million ($705 million). For the first half of the year, sales totaled £1.034 billion ($1.324 billion), representing a 29% growth at constant exchange rates. Full-year sales are expected to exceed £2 billion, positioning Dovato as another blockbuster product for GSK in the HIV treatment field.GSK Successfully Spins Off Consumer Healthcare (CHC) in 2022, Focuses on Four Core Therapeutic Areas in Biopharmaceuticals: Infectious Diseases, HIV, Immunology/Respiratory Diseases, and Oncology.In this earnings report, GSK raised its 2024 guidance, with 2024 sales growth projected at 7% to 9% (previously 5% to 7%); core operating profit growth at 11% to 13% (previously 9% to 11%); and core earnings per share growth at 10% to 12% (previously 8% to 10%).
References:
1. https://www.gsk.com/media/11412/q2-2024-results-announcement.pdf2. GSK：Half Year and Q2 2024 Results3. US FDA Approves GSK's Arexvy Vaccine – The World's First RSV Vaccine for Older Adults4. AREXVY (Adjuvanted RSVPreF3) 2-Year Update
Master and Ph.D. in Medicinal Chemistry, postdoctoral research abroad, currently engaged in drug development, passionate about the pharmaceutical industry, eager to learn and grow with peers, and jointly witness the advancement of innovative drugs.
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