Germany, warta9 – In 2021, Boehringer Ingelheim again increases its annual investment in research and development to a new high in its 137-year history. The company has spent EUR4.1 billion on R&D (2020: EUR3.7 billion), an increase of 11.7%. R&D investment in Human Pharmacy increased to EUR3.7 billion (2020: EUR3.3 billion), while investment in Animal Health increased 1% to EUR416 million (2020: EUR412 million).
“2021 is a good year for patients, for animal owners and for our company. We have expanded our contribution to transforming human and animal life, and further strengthened our combined process,” explains Hubertus von Baumbach, Chairman, Board of Directors. Executor. in a press release received by the editor of warta9, Saturday 8 April 2022.
“Therefore, we have also intensified our efforts in Research and Development, and achieved significant medical advances, including three breakthrough therapeutic designs that were approved by the US FDA for innovative drugs in Human Pharmacy. In Animal Health, we have laid the foundation for launch of innovative new solutions for animals and livestock in 2022 and 2023.”
“We present these results at a time when war is back in Europe,” continued von Baumbach. “Our prayers are with the Ukrainian nation. The aggression against this country is very sad. We support people seeking asylum and people in need of assistance in Ukraine, through short-term and long-term financial support, through product donations and the provision of medicines, and many of our employees are involved in support initiatives using the volunteer workday program. We all hope this dire situation will end soon.”
Growth across the business
Despite the ongoing challenges of COVID-19, 2021 was a successful year. Boehringer Ingelheim recorded net sales of EUR20.6 billion (2020: EUR19.6 billion), an increase of 5.4% over the previous year. After adjusting for currency effects, net sales rose 7.5%.
Operating income at the Group level rose to EUR4.7 billion (2020: EUR4.6 billion). After-tax income increased year-on-year by 11.2% to EUR3.4 billion (2020: EUR3.1 billion). Cash flows from operating activities decreased slightly by EUR117 million to EUR3.9 billion (2020: EUR4.0 billion). At the end of 2021, the equity ratio was recorded at 48% (2020: 47%).
“All of our businesses contributed to solid financial results in 2021, which is a strong achievement, especially when considering the pandemic situation and the economy as a whole. As a result, we have been able to continue to make significant investments and have strengthened our overall financial base – as well as our independence,” said Michael Schmelmer, Member of the Managing Board of Directors responsible for Finance and Group Functions.
“The extraordinary commitment of all of our employees in the second year of the pandemic has driven our achievements. Working conditions are often challenging, both for those of us who work from home almost permanently and for those who work in confined conditions in our factories. In times of need, we all support each other. This makes me feel positive and optimistic, and is critical to the long-term success of our company.”
Human Pharmacy – Significant advances in late-stage R&D process
The R&D process in Human Pharmacy comprises more than 100 clinical and preclinical projects. Based on the progress of the next phase of the project, the process has the potential to result in up to 15 new product launches by 2025.
The main focus of the research is to gain a deeper understanding of the relationship between the different diseases. Empagliflozin is a great example. Initially, it was approved as a type 2 diabetes drug. Investing into a better scientific understanding of the interrelationships of the cardio, kidney and metabolic systems has allowed Boehringer Ingelheim to expand its uses from diabetes to heart failure.
Currently, Empagliflozin is the only approved treatment for adults with symptomatic chronic heart failure in the European Union. In addition, this drug may also be beneficial in a variety of chronic kidney diseases, as shown by reading the positive provisional analysis data from the EMPA KIDNEY trial. This drug is also rated for prevention of heart failure after a heart attack (EMPACT-MI trial).
The pace of innovation from the company’s immunological research was further confirmed by Spesolimab, an IL-36-specific monoclonal antibody for the treatment of generalized pustular psoriasis (GPP).
GPP is a rare and sometimes even life-threatening skin disease without a globally approved treatment. Spesolimab has been approved as the US FDA’s Breakthrough Therapeutic Design, and important data have been published in the New England Journal of Medicine. Regulatory applications for the treatment of ADD have been made across a large geographic area, with the aim of making Spesolimab available to eligible patients this year.
Other inflection points for the company’s R&D process this year include pulmonary fibrosis, the central nervous system (CNS), and oncology. A study to evaluate how PDE4B inhibitors affect lung function in people with idiopathic pulmonary fibrosis (IPF) will be published at a medical conference later this year.
In February 2022, the US FDA has provided a Breakthrough Therapeutic Design for the compound in this indication. In CNS, a Gly-T1 inhibitor was also approved as the US FDA Breakthrough Therapeutic Design for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS), and a high-level reading of data was prepared later for the year.
In addition, at CNS, Boehringer Ingelheim is collaborating on digital therapy CT-155 as an adjustment to pharmacotherapy, which aims to help patients change their behavior and practice new skills. The promising MDM2-p53 antagonist is the most advanced asset in oncology currently in critical phase II clinical trials for rare soft tissue sarcomas, an area of significant medical need for which no new approved therapy exists.
Strong growth for Empagliflozin and Nintedanib
At EUR15.3 billion (2020: EUR14.4 billion), net sales of human medicines grew by 8.4%* and accounted for 74% of total net sales. The United States remains the largest market for Boehringer Ingelheim. The company generated net sales of EUR5.8 billion (2020: EUR5.7 billion) in the US, up 5.9%*.
In the EUCAN region (Europe, Canada, Australia and New Zealand, net sales excluding license revenue) rose 4.1%* to EUR4.4 billion (2020: EUR4.2 billion). In Emerging Markets, including the People’s Republic of China, the company posted net sales of EUR3.0 billion (2020: EUR2.8 billion), an increase of 5.9%*. In Japan, net sales increased by 7.1%* to EUR1.3 billion (2020: EUR1.3 billion).
Drugs for cardiovascular and metabolic treatment, as well as respiratory disorders, remained the most important contributors to net sales. Empagliflozin remains the largest revenue contributor in Human Pharma, generating net sales of EUR3.9 billion (2020: EUR3.1 billion) and growth of 28.6%*. Nintedanib is the company’s second strongest revenue contributor with net sales of EUR2.5 billion (2020: EUR2.1 billion) with a growth of 25.4%*. (**)
