Pharmaceutical R&D Developer

On August 1, Merck KGaA (Merck KGaA) Released the financial report for the second quarter and first half of 2024. The group's net sales in all businesses increased by 1.7% to 5.4 billion euros. Among them,The pharmaceutical business of the company (Healthcare) The Second QuarterSalesAmounting to 2.137 billion euros, an increase of 5.3%;Sales in the first half of the year amounted to 4.184 billion euros., an increase of 7.6%。The report pointed out that this growth was mainly driven by revenue increases in the fields of oncology, cardiovascular, metabolism, and endocrinology.

Oncology Field
Oncology Business Q2 Revenue was €490 Million, up 9.2%; H1 Revenue was €990 Million, up 14.1%。
Screenshot from:Merck Financial Report
Erbitux (Cetuximab)
In the field of oncology,EGFR Monoclonal Antibody Erbitux Remains Merck KGaA's Best-Selling Anti-Cancer Drug, the drugTheSales in the second quarter were 276 million euros, an increase of 8.2%.;Sales in the first half of the year were 563 million euros, up 13.6%According to the report, the strong growth in Erbitux's second-quarter sales was mainly driven by growth in Europe, Latin America, and the Asia-Pacific region.
Cetuximab is the standard treatment for EGFR-expressing, RAS wild-type metastatic colorectal cancer as well as recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck. Currently, Merck KGaA has nearly 200 active clinical trials involving cetuximab, including over 15 Phase III studies.
Bavencio (Avelumab)
Anti-PD-L1 Antibody BavencioSales in the second quarter were €186 million, up 6.4%; sales in the first half of the year were €372 million, up 10.2%.Bavencio's robust growth in the second quarter was mainly driven by revenue contributions from all regions except North America.
Bavencio has been approved in more than 70 countries/regions as a first-line maintenance treatment for advanced urothelial carcinoma. Based on the results of the JAVELIN Bladder 100 trial, it has become the standard treatment for this disease. Bavencio is also approved in combination with axitinib for first-line treatment of advanced renal cell carcinoma and is indicated for metastatic Merkel cell carcinoma (A Rare Skin Cancer) as the standard treatment for monotherapy.
Progress in Other Tumor Pipelines
Merck also disclosed the progress of the company's other product pipelines in the field of oncology.Among them, the oral MET inhibitor Tepmetko (Tepotinib) has been launched in approximately 40 markets worldwide, with regulatory applications under review in other markets.In February this year, the FDA officially approved Tepmetko (Previously, the drug had received FDA accelerated approval.)。
In June this year, Merck announcedTermination of the Randomized Phase III TrilynX Study of IAP Inhibitor Xevinapant, the study aims to evaluate xevinapant in combination with chemoradiotherapy for unresected locally advanced squamous cell carcinoma of the head and neck(LA SCCHN) in patients. Another Phase III clinical trial of xevinapant, XRay Vision, has also been halted. This study aimed to evaluate the efficacy of xevinapant combined with radiotherapy in patients with resected LA SCCHN.
In the first half of 2024, Merck also presented an anti-CEACAM5 antibody-drug conjugate (ADC) M9140 Phase Ia Study Results in Advanced Colorectal Cancer.This is the first ADC developed by Merck to enter clinical development., has now entered intoColorectal CancerPhase Ib.
Moreover, in the DNA damage response (DDR) In the product portfolio, Merck stated that it will continue to advanceATR Inhibitor Tuvusertib (M1774). The company is exploring four combinations of Tuvusertib in three Phase II clinical trials, involving indications including non-squamous non-small cell lung cancer, PARP inhibitor-resistant ovarian cancer, and advanced urothelial carcinoma.

Neurology and Immunology Fields
Neurology and Immunology Products Q2 Sales were €434 million, a decrease of -7.4%; H1 sales amounted to €853 million, roughly flat compared to the same period last year.

Screenshot from:Merck Financial Report
In the fields of neurology and immunology, Merck's current product portfolio includes two treatments for relapsing MS (RMS) The approved product ---- Rebif (Interferon β-1a) and Mavenclad (Cladribine Tablets)。
Rebif is a disease-modifying drug and has been the standard treatment for RMS for more than 20 years.The drug's Q2 sales were €168 million, a decrease of -18.5%; H1 sales were €326 million, a decrease of -9.0%.The report pointed out that the decline in Rebif's sales in the second quarter was due to the continued fierce competition in the interferon market, as well as competition from oral formulations and highly effective MS therapies. It is expected that these factors will lead to a further decrease in the drug's sales in the future.
Mavenclad, a short-term oral therapy for treating various forms of highly active RMS in adult patients, has been approved in 95 countries and regions worldwide, including the European Union, Switzerland, Australia, Canada, and the United States.The drug's sales in the second quarter were €266 million, increasing by 1.3%; the sales in the first half of the year were €527 million, increasing by 6.5%.。
Besides MS, Merck stated that it will continue to expand its product portfolio in the fields of neurology and immunology, developing potential first-in-class therapies for patients whose medical needs are yet unmet. In June 2023, the FDA granted designation to oral cladribine for the treatment of myasthenia gravis.Cladribine) New formulation orphan drug designation. Merck KGaA launched a global Phase III clinical trial in June 2024.
In addition, Enpatoran developed by Merck is a Toll-like receptor 7 and 8 (TLR7/8) inhibitor, currently in Phase II clinical development. Merck expects the Phase II results of Enpatoran in cutaneous lupus erythematosus and systemic lupus to be announced in early 2025.

Cardiovascular, Metabolism and Endocrinology
The product portfolio in the cardiovascular, metabolic, and endocrine fields includes drugs such as Glucophage, Euthyrox, Concor, and Saizen, which is the largest sales segment of Merck's pharmaceutical business unit.Sales in this field reached EUR 746 million in the second quarter, up 13.7%; sales in the first half of the year amounted to EUR 1.435 billion, increasing by 8.9%.%。

Screenshot from:Merck Financial Report
Glucophage, containing the active ingredient metformin, is a first-line medication for treating type 2 diabetes and is available in over 100 countries.The drug's sales in the second quarter were 238 million euros, increasing by 23.5%; the sales in the first half of the year were 459 million euros, increasing by 13.8%.。
Concor contains bisoprolol, which is a beta-blocker used to treat hypertension and cardiovascular diseases. In addition to Concor/Concor Cor, the Concor series also includes fixed-dose combinations such as Concor Plus/Lodoz (Bisoprolol and Hydrochlorothiazide)。Concor The Second QuarterSales reached €158 million, increasing by 13.2%; sales in the first half of the year amounted to €297 million, growing by 7.4%.
Euthyrox, containing the active ingredient levothyroxine, is a medication for treating hypothyroidism. The drug's sales in the second quarter reached 155 million euros, increasing by 19.2%; the sales in the first half of the year amounted to 294 million euros, growing by 14.1%.
Saizen, containing the active ingredient somatropin, is Merck KGaA's key endocrine product used to treat various growth hormone disorders in both children and adults.The drug's sales in the second quarter were 97 million euros, increasing by 23.0%; the sales in the first half of the year were 186 million euros, increasing by 20%.。
References:
Merck Returns to Organic Sales Growth. https://www.merckgroup.com/en/news/q2-2024-01-08-2024.html
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