Our Healthcare business sector helps to create, improve, and prolong lives across the therapeutic areas of oncology, neurology & immunology and fertility as well as cardiovascular, metabolic and endocrinological disorders. As a global specialty innovator, with a strong established business, we deliver a diversified portfolio of therapies to millions of patients around the world, every day.
Throughout the reporting year 2024, we ensured the supply of our medicines beyond the demand anticipated at the start of the year despite ongoing geopolitical crises. Even as some of our competitors experienced shortages, we provided support and worked diligently to ensure, whenever possible, that patients could access an alternative therapeutic option.
In 2024, Healthcare generated 40% of Group sales and 46% of EBITDA pre (excluding Corporate and Other). Europe and North America generated 53% of Healthcare’s net sales in the reporting year. Asia-Pacific and Latin America accounted for 40% of sales in 2024.
Oncology
Erbitux® (cetuximab) remains our best-selling healthcare product with € 1,162 million in sales in 2024. Erbitux® is a standard of care for patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer (mCRC) as well as both recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck (SCCHN). With approximately 200 active clinical trials involving Erbitux®, including more than 30 Phase III trials, we are committed to continuously advancing our robust lifecycle management strategy.
We have continued to make progress in transforming the global standard of care for patients with locally advanced or metastatic urothelial carcinoma (UC) as we continue to obtain additional regulatory and reimbursement approvals for Bavencio® (avelumab), our anti-PD-L1 antibody. Currently approved as a first-line maintenance treatment for advanced UC in over 70 countries, Bavencio® has become a standard of care in the treatment of this disease based on the results of the pivotal JAVELIN Bladder 100 trial, the only Phase III trial of an immunotherapy to demonstrate a significant overall survival benefit in the first-line maintenance setting.
Bavencio® is also approved in the first-line treatment of advanced renal cell carcinoma in combination with axitinib and is a standard of care as a monotherapy in metastatic Merkel cell carcinoma, a rare form of skin cancer.
We are also continuing to expand the availability of Tepmetko® (tepotinib), our oral MET inhibitor designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations. In February, the U.S. Food and Drug Administration (FDA) granted full approval to Tepmetko®, which had previously been available in the United States under accelerated approval. Tepmetko® is now available in approximately 40 markets globally, with regulatory submissions under review in additional markets.
In June 2024, we announced the discontinuation of the randomized Phase III TrilynX trial evaluating xevinapant plus chemoradiotherapy in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). The Phase III clinical trial XRay Vision evaluating xevinapant plus radiotherapy in patients with resected LA SCCHN was also discontinued (see “Research and Development” for further details).
We continued to advance our pipeline of novel oncology medicines in 2024. We presented first-in-human data for the first antibody-drug conjugate (ADC) developed in our labs, M9140, an ADC targeting carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5), and advanced a second ADC, targeting GD2 (disialoganglioside expressed on tumors) into a Phase I clinical trial (see “Research and Development” for further details).
We also initiated new clinical studies for our portfolio of small-molecule DNA damage response (DDR) inhibitors. With our potent and selective inhibitor of ataxia telangiectasia and Rad3-related (ATR) tuvusertib (M1774) and the selective PARP1 (poly ADP-ribose polymerase 1) inhibitor M9466 (also known as HRS-1167), licensed from Jiangsu Hengrui Pharmaceuticals Co. Ltd., we are exploring the potential of these investigational compounds in various tumors. This includes a Phase II trial opened in 2024 to evaluate the potential of two combinations with tuvusertib to overcome resistance to PARP inhibition in ovarian cancer (see “Research and Development” for further details).
Neurology & Immunology
We develop therapies for people living with neurological and immune-mediated conditions and aim to help significantly improve quality of life for them and their caregivers. Our portfolio is the result of over two decades of experience in MS research and currently includes two approved products for the treatment of relapsing MS (RMS): Rebif® (interferon beta-1a) and Mavenclad® (cladribine tablets).
Mavenclad®, the only short-course, oral disease-modifying therapy for the treatment of adults with various forms of highly active relapsing MS, achieved blockbuster status in 2024 for the second consecutive year, with total net sales of more than US$ 1 billion (€ 1,062 million). More than 100,000 patients have now benefited from Mavenclad® across more than 90 countries, including those of the European Union, Switzerland, Australia, Canada, and the United States. Rebif®, a disease-modifying drug, has been a standard treatment in RMS for over 20 years with almost 2 million patient-years of therapy since approval.
Beyond MS, we are continuing to expand the disease focus of our Neurology & Immunology therapeutic area by developing potential first-in-class treatments for conditions with high unmet medical needs. In June 2023, the FDA granted orphan drug designation for cladribine capsules for the treatment of generalized myasthenia gravis (gMG), and we initiated a global Phase III clinical trial program in June 2024.
In immunology, we have a Phase II clinical trial program of the investigational oral therapy enpatoran in cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE). In October 2024, we shared an analysis from the CLE cohort of the study, which showed that enpatoran met its primary endpoint with an acceptable safety profile in CLE patients. The results from the SLE cohort of the study are anticipated in early 2025.
Fertility
We are a global market leader in fertility drugs and treatments. Infertility is an increasing challenge globally due to demographic change and lifestyle adjustments. Based on the latest data from WHO, one in six people worldwide is affected by infertility.
With our broad portfolio of treatment options, devices, and advanced fertility technologies, we aim to contribute to improved treatment outcomes that help couples fulfill the dream of parenthood.
According to the latest data, more than six million babies have been born worldwide with the help of Gonal-f®, a therapeutic within our Fertility portfolio. It contains the active ingredient follitropin alfa (r-hFSH alfa), which is a recombinant form of the natural hormone FSH and is available in a convenient and ready-to-use pre-filled injection pen. A recent real-world study from France showed improved live birth outcomes with Gonal-f® compared with other commonly used gonadotropins. Real-world evidence complements randomized clinical trials by providing additional insights into long-term treatment effects in large, heterogeneous patient populations.
To support and meet the needs of a variety of patients, in addition to Gonal-f®, we also offer another key product called Pergoveris®. This product combines recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH) and represents another treatment option for women with severe FSH and LH deficiency. Pergoveris® is also available as a ready-to-use pre-filled injection pen, eliminating the need for mixing. To complement Pergoveris® and Gonal-f®, we offer Ovidrel® rhCG, Cetrotide® GnrRH antagonist and Crinone® progesterone.
Cardiovascular, Metabolism & Endocrinology
The Cardiovascular, Metabolism & Endocrinology (CM&E) portfolio, which includes the medicines Glucophage®, Euthyrox®, Concor®, and Saizen®, is the largest franchise of the Healthcare business sector in terms of sales.
Glucophage®, containing the active ingredient metformin, is a drug for the first-line treatment of type 2 diabetes and is available in more than 100 countries. In recent years, Glucophage® has been approved by additional health authorities for use in prediabetes in cases where pronounced lifestyle changes failed to produce the desired outcome.
Euthyrox®, with the active ingredient levothyroxine, is a leading medicine for the treatment of hypothyroidism, a disease with high prevalence but still low diagnosis rates in most emerging markets.
Concor®/Concor Cor®, containing bisoprolol, is a beta-blocker for treating hypertension and cardiovascular diseases such as coronary heart disease and chronic heart failure. In addition to Concor®/Concor Cor®, the Concor® family includes fixed-dose combinations such as Concor Plus®/Lodoz® (bisoprolol with hydrochlorothiazide).
Saizen®, which contains the active ingredient somatropin, is our primary endocrinology product and is indicated for the treatment of various growth hormone disorders in both children and adults. Saizen® can be administered using the Easypod® auto-injector, the only growth hormone injection device capable of remotely transferring data such as injection times, dates, and doses to the web-based software system Growzen® Connect, which can be accessed by healthcare professionals, patients and caregivers. Alternatively, Saizen® can be delivered using Aluetta, a simple pen injection device.