In Healthcare, we operate as a global specialty innovator in the Neurology & Immunology and Oncology franchises as well as in the therapeutic areas of fertility and cardiovascular, metabolic and endocrinological disorders. The Healthcare business sector discovers, develops, manufactures, and markets pharmaceutical and biological prescription drugs to treat cancer, multiple sclerosis (MS), infertility, and growth disorders as well as certain cardiovascular and metabolic diseases. Our R&D pipeline is focused on strengthening our position in the fields of oncology, neurology and immunology.
In 2023, Healthcare generated 38% of Group sales and 41% of EBITDA pre (excluding Corporate and Other). Europe and North America generated 53% of Healthcare’s net sales in 2023. In recent years, we have steadily expanded our presence in growth markets. In 2023, Asia-Pacific and Latin America accounted for 40% of sales.
Oncology
Erbitux® (cetuximab) remains our best-selling cancer drug with € 1 billion in sales in 2023. The drug 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 more than 200 active clinical trials involving Erbitux®, including more than 15 Phase III studies, we are also continuously advancing our broad-based lifecycle management strategy.
We have made progress in changing the standard of care globally for patients with locally advanced or metastatic urothelial carcinoma (UC) as we continue to obtain additional regulatory approvals and reimbursement decisions for our anti-PD-L1 antibody Bavencio® (avelumab) (for further details see “Research and Development”). Bavencio® is approved as a first-line maintenance treatment for advanced UC in 71 countries. It has become a standard of care in the treatment of this disease based on the results of the JAVELIN Bladder 100 trial, the only Phase III study of an immunotherapy to demonstrate a significant overall survival benefit in the first-line maintenance setting.
Through our subsidiary Ares Trading SA, we regained exclusive worldwide rights to develop, manufacture and commercialize Bavencio® from Pfizer as of June 30, 2023.
Bavencio® is also approved in the first-line treatment of advanced renal cell carcinoma in combination with axitinib and it is a standard of care as a monotherapy in metastatic Merkel cell carcinoma (MCC), a rare form of skin cancer.
In September 2023, we received U.S. Food and Drug Administration approval of a supplemental Biologics Licensing Application for Bavencio®, converting the MCC indication from accelerated approval into full approval approximately four years earlier than anticipated. As a result, Bavencio® is the first MCC treatment to receive full approval in the U.S. market.
In 2023, we also continued to expand the availability of Tepmetko® (tepotinib), our oral MET inhibitor designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations, with additional regulatory approvals. Tepmetko® is now available in 43 markets globally.
In the therapeutic area of SCCHN, we advanced our global Phase III development program for xevinapant, an IAP (inhibitor of apoptosis protein) inhibitor in 2023, with enrollment completed in the TrilynX study. The recruitment of patients in the XRay Vision study is ongoing (for further details see “Research and Development”).
In fiscal 2023, we also continued to advance our efforts in novel medicines. For the first antibody-drug conjugate (ADC) developed in our labs, the anti-CEACAM5 ADC M9140, we completed the dose-finding portion of our Phase I study (for further details see “Research and Development”).
Beyond our ADC platform, we are also evaluating small-molecule DNA damage response (DDR) inhibitors as this therapeutic class has the potential for better outcomes in patients with cancer.
Within our DDR portfolio, we continue to advance the development of our potent and selective inhibitor of ataxia telangiectasia and Rad3-related (ATR), tuvusertib (M1774). We initiated the Phase Ib/IIa DDRiver NSCLC 322 study of tuvusertib in combination with cemiplimab in participants with non-squamous non-small cell lung cancer (NSCLC) (for further details see “Research and Development”).
Neurology & Immunology
In Neurology & Immunology, we aim to provide transformative treatment solutions to support people living with neurological and immune-mediated conditions while significantly improving quality of life for them and their caregivers. With over two decades of experience in MS, our current portfolio includes two approved products for the treatment of relapsing MS (RMS) – Rebif® (interferon beta-1a) and Mavenclad® (cladribine tablets).
Rebif®, a disease-modifying drug, has been a standard treatment in RMS for over 20 years with more than 1.9 million patient-years of therapy since approval.
Mavenclad®, a short-course oral therapy for the treatment of adults with various forms of highly active RMS, reached blockbuster status in fiscal 2023 with total net sales of more than US$ 1 billion, and is approved in 95 countries worldwide, including those of the European Union, Switzerland, Australia, Canada, and the United States.
With evobrutinib, we had originally aimed to commercialize a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor for RMS. In December, we shared the outcome from the EVOLUTION clinical trials, which showed that the investigational drug did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide.
Fertility
Our Fertility franchise is a global market leader in fertility drugs and treatments.
Infertility is an increasing challenge globally due to demographic changes and lifestyle adjustments such as delayed childbearing. Based on the latest data from WHO, one in six people worldwide is affected by infertility.
According to the latest data, more than five 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. Treatment with Gonal-f® can result in increased follicles, oocytes, and embryos compared to urinary gonadotropins, thereby improving the chances of pregnancy and live birth.
To support and meet the needs of a variety of patients, in addition to Gonal-f®, we offer another key product called Pergoveris®. It is a product that combines recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). This represents another treatment option for women with severe FSH and LH deficiency. Pergoveris® is also available in a ready-to-use liquid version in a pre-filled injection pen, eliminating the need for mixing.
In September 2023, we announced our new employee “Fertility Benefit” program. The new offer is available to our employees in a number of countries and to their partners, regardless of their marital status. Apart from financial assistance, we offer employees facing fertility issues additional information services related to fertility disorders.
Cardiovascular, Metabolism & Endocrinology
Cardiovascular, Metabolism & Endocrinology (CM&E), which includes the medicines Glucophage®, Euthyrox®, Concor®, and Saizen®, is the largest franchise of the Healthcare business sector in terms of sales.
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).
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.
Glucophage®, containing the active ingredient metformin, is a drug for first-line treatment of type 2 diabetes and is available in more than 100 countries. In recent financial years, Glucophage® has been approved by further health authorities for use in prediabetes when intensive lifestyle changes failed.
Saizen®, containing the active ingredient somatropin, is our main endocrinology product and is indicated for the treatment of multiple growth hormone disorders in children and adults. Saizen® can be delivered with the Easypod® electromechanical injection device, the only growth hormone injection device able to wirelessly transfer data such as injection times, dates and doses to the web-based software system Growzen® Connect. Aluetta® (the Saizen® pen) is now available in 67 countries with the objective of expanding the reach of Saizen®, offering additional options for healthcare practitioners and patients and expanding our devices portfolio.
In endocrinology, we build evidence in the digital health space and leverage technology to provide new solutions for patient engagement, partnership with healthcare practitioners and better payer value proposition.
Minimizing the ecological footprint of our operations*
We are continuously taking action to further reduce the negative ecological impact of our operations on our planet with a holistic approach that includes our locations, products, logistics and patients. A portfolio-related activity to reduce the ecological footprint of our operations is the partnership we entered in May with Novo Nordisk, Eli Lilly and Sanofi to pioneer the world's first cross-industry solution for recycling materials from injection pens after use by patients.
Denmark was chosen because of the existing recycling infrastructure in the country. Today, the four companies involved in this partnership account for around six million injection pens used in Denmark annually. The ambitious target for the first 12 months is for 25% of all injection pens distributed by the four companies in Denmark to be recycled, amounting to more than 25 metric tons of plastic.
* The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically.