First half of 2021: Boehringer Ingelheim makes fundamental progress in research and development

• Breakthrough results in the treatment of a type of heart failure, which is extremely difficult to manage
• Strong progress in mental health pipeline
• Good business performance in all areas, despite ongoing impact of COVID-19

INGELHEIM, Germany–(BUSINESS WIRE)–In the first half of 2021, Boehringer Ingelheim has supplied more humans and animals worldwide with innovative medicines than ever before. The company’s success is based on its rich R&D portfolio with a focus on diseases with high unmet medical need. The R&D pipeline in Human Pharma comprises more than 60 new substances and around 100 clinical and pre-clinical projects. This pipeline has the potential to deliver up to 15 medicines for approval by 2025.

In July, Boehringer Ingelheim reported a breakthrough in the treatment of heart failure with empagliflozin (marketed as JARDIANCE^®). More than 60 million patients worldwide suffer from this disease, approx. half of them from heart failure with preserved ejection fraction (HFpEF). Heart failure with left ventricular preserved ejection fraction occurs when the left ventricle of the heart is unable to fill properly, resulting in less blood being pumped to the body. A recent trial showed a significantly lower risk with empagliflozin of hospitalization for heart failure or cardiovascular death in adult patients with HFpEF. If approved, empagliflozin from Boehringer Ingelheim would become the first and only clinically proven therapy to improve outcomes across the full spectrum of heart failure patients regardless of ejection fraction. In June, the European Commission granted marketing authorization for JARDIANCE^® as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).

“Despite all the medical progress made in recent decades, there are still many diseases for which there is yet no adequate treatment available. That is why we at Boehringer Ingelheim focus on areas where the need for medical innovation is high,” said Hubertus von Baumbach, Chairman of the Board of Managing Directors. “Our strong R&D pipeline has made further, decisive progress in the first half of 2021. These medical successes have the potential to improve the lives of millions of patients worldwide.”

Progress in mental health pipeline

Boehringer Ingelheim also made progress in the area of neuropsychiatric disorders, including two ongoing phase II trials. At the end of May, Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for BI 425809, a key component of the company’s mental health research program, for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS). Boehringer Ingelheim also announced the planned initiation of the innovative CONNEX Phase III clinical trial program assessing the safety and efficacy of BI 425809, a novel glycine transporter-1 (GlyT1) inhibitor, for improving cognition in adults with schizophrenia.

The company supplemented its own research and development capabilities and medical pipeline with further high-profile partnerships, among others in the fields of quantum computing and data science. In June, Boehringer Ingelheim became a founding member of the Quantum Technology and Application Consortium (QUTAC), which unites ten of the leading German companies in exploring industrial applications for quantum computing. Quantum computing holds enormous potential for pharmaceutical research and development, particularly for early research processes in which Boehringer Ingelheim has a high level of expertise.

Boehringer Ingelheim also remains committed to the search for potential therapeutics against the SARS-CoV-2 virus. In July, the company announced that it will focus its COVID-19 therapy research on the development of alteplase as a potential treatment for COVID-19 patients with severe breathing problems, called acute respiratory distress syndrome (ARDS). The decision is based on favorable safety and efficacy data from an interim analysis of the TRISTARDS Phase 2/3 study, following completion of the Phase 2b part of the study including 62 patients. The BI 767551 SARS-CoV-2 neutralizing antibody development program will be discontinued, as the current state of the pandemic makes it challenging to further progress clinical development of this antibody and make it available to patients within a reasonable time frame to contribute against the COVID-19 pandemic.

Solid business performance despite ongoing pandemic effects

Following a successful financial year 2020, Boehringer Ingelheim continued its positive trend in the first half of 2021. In the first six months, the company generated net sales of 9.8 billion EUR, up 5.8 percent (year on year and adjusted for currency effects). All three business areas (Human Pharma, Animal Health, Biopharmaceutical Contract Manufacturing) contributed to the net sales growth.

“Together with our employees, we achieved solid financial results in the first half of the year, even when the COVID-19 pandemic continues to have an impact,” said Michael Schmelmer, member of the Board of Managing Directors with responsibility for Finance & Group Functions. “We see that in a lot of countries, people avoid seeing their doctors because of COVID-19, even if they are in urgent need of diagnosis and treatment. This non-treatment poses a serious medical problem, which we must take into consideration even more when fighting the pandemic.”

Human Pharma: JARDIANCE^® and OFEV^® growth drivers

In Human Pharma, Boehringer Ingelheim achieved net sales of 7.1 billion EUR in the first half of the year, equal to the high level of last year. Adjusted for currency effects, net sales increased by 5 percent year on year.

Growth in Human Pharma continues to be driven by the SGLT-2 inhibitor JARDIANCE^® and the respiratory medicine OFEV^®. Net sales generated by JARDIANCE^® increased by 17.2 percent (year on year and adjusted for currency effects) to 1.4 billion EUR. Boehringer Ingelheim has co-developed and markets JARDIANCE^® together with Eli Lilly and Company. Net sales of the respiratory product OFEV^® increased by 28.9 percent (year on year and adjusted for currency effects) and amounted to 1.2 billion EUR. OFEV^® is approved for the treatment of people living with idiopathic pulmonary fibrosis (IPF) in more than 80 countries, for systemic sclerosis-associated ILD (SSc-ILD) in more than 70 countries, and for other chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILDs) in more than 60 countries.

Animal Health shows good results in pet and livestock business

Boehringer Ingelheim has a full pipeline of R&D projects to develop innovative solutions for the health of pets and livestock. One example is the clinical trial on velagliflozin, a SGLT2-inhibitor with therapeutic potential to treat diabetes in cats. Velagliflozin has been developed primarily for use in treating Type 2 diabetes in humans by lowering blood sugar and now provides an opportunity for application in animal health. To complement its own R&D portfolio, Boehringer Ingelheim has entered into promising new partnerships in the area of animal health. In the first half of 2021 this included partnerships with PetMedix for the development of new and transformative antibody therapeutics for pets, and with Lifebit Biotech to detect and early-report global infectious disease outbreaks by using Artificial Intelligence.

In the first half of 2021, Boehringer Ingelheim generated strong net sales of around 2.3 billion EUR in the Animal Health business area. Adjusted for currency effects, year-on-year sales were up 9.6 percent in this highly competitive market.

The antiparasitic medicine NEXGARD^® for dogs remained the best-selling product with net sales up 16.4 percent (year on year and adjusted for currency effects) to 488 million EUR. FRONTLINE^®, which is indicated for the treatment and prevention of fleas, ticks and chewing lice in dogs and cats, generated net sales of 267 million EUR, up 8.9 percent (year on year and adjusted for currency effects).

Net sales of HEARTGARD^®, the heartworm prevention product for dogs, declined slightly by 0.2 percent (year on year and adjusted for currency effects) to 173 million EUR. Net sales of the swine vaccine INGELVAC CIRCOFLEX^® continued to recover in many countries with the decline of African swine fever. INGELVAC CIRCOFLEX^® sales grew by 18.1 percent (year on year and adjusted for currency effects) to 145 million EUR.

Biopharmaceutical Contract Manufacturing: Inauguration of new production facility in Vienna, Austria, in October

Demand in Biopharmaceutical Contract Manufacturing remains high. Net sales rose 1.1 percent (year on year and adjusted for currency effects) to 322 million EUR. Boehringer Ingelheim is further expanding its biopharmaceutical production capacity to continue to meet growing demand. The company will inaugurate its large-scale cell culture (LSCC) facility in Vienna, Austria, in October, including up to 150,000L manufacturing capacities for Boehringer Ingelheim products and contract manufacturing.

Please click on the following link for ‘Notes to Editors’:

http://www.boehringer-ingelheim.com/press-release/boehringer-ingelheims-half-year-figures-2021

Contacts

Boehringer Ingelheim
Corporate Communications

Matthias Knotzer

55216 Ingelheim/Germany

Phone: +49 6132 – 77172107

Fax: +49 6132 – 77 6601

Email: [email protected]