Zongertinib

Human Pharma sales up 10.3%* to EUR 20.8 bn, driven by JARDIANCE® and OFEV®Animal Health sales up 6.9 %* to EUR 4.7 bn, fueled by new product launchesR&D expenditures increase by 14.2% to EUR 5.8 bn Boehringer Ingelheim today announced a strong acceleration of its pipeline in 2023, as pivotal trials in key research areas progressed as planned. Research & Development (R&D) investments increased by 14.2% to EUR 5.8 billion. R&D investments were substantial, at 22.5% of net sales. Group net sales rose by 9.7%* to EUR 25.6 billion in 2023, driven by 10.3%* growth in Human Pharma and 6.9%* growth in Animal Health. Both businesses outperformed their markets. In 2023, regulators awarded five additional FDA fast-track designations and one FDA breakthrough therapy designation in the US, as well as one EMA PRIME scheme acceptance in Europe. With a focus on therapeutic research areas in cardiovascular, renal and metabolic diseases (CRM), oncology, respiratory diseases, immunology, mental health, and retinal health, the company is a pioneer in breakthrough treatments in areas of high unmet patient needs. “I am excited to see how balanced and healthy our pipeline looks today,” said Hubertus von Baumbach, Chairman of the Board of Managing Directors. “We are determined to accelerate the development of our range of new treatments and make them available to patients in the best and fastest ways. In doing so, it is our mission to not only help patients, but also to help make healthcare systems fairer and better.” Human Pharma portfolio shows strong growth JARDIANCE®, which is used to treat type 2 diabetes and heart failure, continued its strong momentum in 2023, as sales rose by 31.0%* to EUR 7.4 billion. Sales of OFEV®, a medicine for the treatment of patients with idiopathic pulmonary fibrosis and certain fibrosing interstitial lung diseases, increased 12.8%* to EUR 3.5 billion. JARDIANCE® also received regulatory approval in Europe and the United States for a third indication, the treatment of chronic kidney disease. Some 850 million people are estimated to suffer from this chronic disease worldwide. JARDIANCE® can now potentially help manage cardiovascular-renal-metabolic conditions of more than 1 billion people. Continued high investments in Human Pharma R&D Compounds in the late-stage portfolio accelerated significantly in oncology, CRM and mental health. Brigimadlin advanced into the key trial for the treatment of dedifferentiated liposarcoma, a rare cancer with limited treatment options so far. The clinical development of zongertinib was accelerated, based upon positive early clinical data. Survodutide showed groundbreaking Phase II results in liver disease due to metabolic dysfunction-associated steatohepatitis (MASH), and also moved into Phase III obesity trials. R&D investments in Human Pharma rose to EUR 5.2 billion in 2023, 25.1% of Human Pharma net sales (EUR 20.8 billion). Additionally, Boehringer Ingelheim also stepped up its investments in digital technologies and IT for R&D to seize new opportunities, including the use of Artificial Intelligence. “Our 2023 investments rank us among the top R&D investors in the industry,” said Michael Schmelmer, Member of the Board of Managing Directors with responsibility for Finance & Group Functions. “We are committed to upholding these high investment levels to ensure that we bring innovation to patients as fast as possible across our entire pipeline. Our more than 53,500 employees know that every day that we gain can make a real difference in patients' lives.” Animal Health: strong growth from new product launches With 6.9%* growth in net sales to EUR 4.7 billion in 2023, the Animal Health business strengthened its market share in the pets, equine and livestock business segments. Growth was driven by increased demand across its diverse portfolio, including pet parasiticides, pet therapeutics and vaccines. NEXGARD®, a soft chew for flea and tick protection in dogs and the company’s largest product in the Animal Health portfolio, rose by 17.2%* to EUR 1.2 billion. In 2023, Boehringer Ingelheim launched four new major products: SENVELGO® for cats with diabetes, NexGard® PLUS to protects dogs against fleas, ticks, heartworm disease, roundworms and hookworms, NexGard® COMBO that protects against fleas and ticks, prevents heartworm disease, and treats and controls roundworms, hookworms, and tapeworms and FRONTPRO®, a non-prescription chewable tablet for the control of fleas and ticks on dogs. The new products all contributed to sales growth. Ongoing high Capital Expenditure To support the company’s growth, Boehringer announced a 5-year, EUR 7 billion capital investment plan last year. In 2023, Capital Expenditure reached EUR 1.2 billion under this program. Prominent investments in Germany include the Chemical Innovation Plant and the biomass power plant in Ingelheim, as well as the Biologicals Development Center in Biberach. Over the past five years, Boehringer’s capital investments reached EUR 6.0 billion, of which EUR 2.9 billion in Germany alone. Sustainable Development Boehringer also further evolved its sustainability program to deepen the focus on health equity in areas where it can make the most relevant contribution to society and environment. Important initiatives include support for the public-private Defeat-NCD Partnership which aims for health coverage for non-communicable diseases in less developed regions and the “Angels” initiative, which has become the largest stroke community in the world and helped 16 million stroke patients in 155 countries receive optimized care. “STOP Rabies” last year provided 43.2 million vaccine doses in endemic countries, 8,000 of these via drone delivery to rural communities in Kenya. In 2023, Boehringer received the German Sustainability Award for its global efforts in pioneering sustainable transformation in the pharmaceutical industry and its decarbonization strategy was validated by the Science Based Target initiative to be in alignment with the 2015 Paris Climate Accord. Outlook The company plans to start ten new phase II and III trials in the next 12-18 months, aiming for 25 new treatment launches in Human Pharma until 2030. In Animal Health, 20 additional launches are expected across markets until 2026, including product updates, indication expansion and new products. For 2024, Boehringer Ingelheim expects a slight year-on-year increase in revenues on a comparable basis, adjusted for currency and extraordinary effects. *sales growth numbers are adjusted for currency effects Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at www.boehringer-ingelheim.com. Intended Audiences Notice This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business. Attachment Press photo

German drugmaker Boehringer Ingelheim collected $22.5 billion in full-year pharma sales. Boehringer Ingelheim’s 2023 was largely marked by the highly anticipated launch of its Cyltezo, the first interchangeable biosimilar to AbbVie’s Humira. But with sales disappointing, the company is now turning its attention to a deep late-stage pipeline that could bring 25 new treatments to market through 2030. Alongside that ambitious goal, Boehringer plans to kick off 10 new phase 2 and 3 trials in the next 12-18 months, it said in its full-year earnings release. The company specifically highlighted its oral MDM2-p53 antagonist brigimadlin, which recently entered a key trial testing the candidate in patients with rare cancer dedifferentiated liposarcoma, and its HER2 tyrosine kinase inhibitor zongertinib. Also on the horizon is Boehringer’s metabolic dysfunction-associated steatohepatitis-related liver disease prospect survodutide. In a recently reported phase 2 trial, the med improved disease in 83% of patients. Survodutide is a novel glucagon/GLP-1 receptor dual agonist, a drug class that has more than proven its worth in weight loss and obesity. Chasing similar indications from GLP-1 makers such as Eli Lilly and Novo Nordisk, Boehringer’s candidate is currently being tested in phase 3 obesity studies. As for its commercialized drugs, the star of the company’s portfolio is once again its Eli Lilly-partnered diabetes powerhouse Jardiance. With a recent U.S. and European chronic kidney disease nod in hand, the drug reached new heights with 31% growth to $8 billion. The new indication could potentially help cover cardiovascular-renal-metabolic conditions in more than 1 billion patiens, Boehringer noted. Other than Jardiance, the company’s Ofev also served as a growth driver. That med, which treats idiopathic pulmonary fibrosis and certain fibrosing interstitial lung diseases, rose 12.8% to $3.8 billion. All in all, Boehringer’s total human pharma sales rose 10.3% to $22.5 billion in 2023. The company also touts a thriving animal health business that contributed $5.1 billion to its top line of $27.6 billion. 2024 revenues are projected to be a “slight” year-over-year increase “on a comparable basis,” Boehringer said. The German drugmaker recently disclosed a plan to lay off staffers from its customer-facing teams for Cyltezo as part of a pivot toward a hybrid in-person and virtual sales model in the face of tamer than expected sales.   Still, Boehringer “remains committed” to the biosimilar, a spokesperson told Fierce Pharma at the time. Along with Cyltezo, the company also markets an unbranded copy of the drug that is sold at an 81% discount to Humira. The branded version, meanwhile, comes with a 5% discount to AbbVie’s original blockbuster.