Boehringer Ingelheim is concentrating on expanding its pipeline beyond Jardiance and other key products.
By Christiane Truelove • [email protected]
Binger Strasse 173, 55216 Ingelheim am Rhein, Germany
+49-6132-77 0 • boehringer-ingelheim.com
|2022||2021||1H 2023||1H 2022|
All sales and figures are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2022: €1.0534.
All sales and figures are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2022: €1.0534.
- Jardiance $6,143
- Ofev $3,399
- Trajenta/Jentadueto $1,794
- Spiriva $1,643
- Pradaxa $1,167
1H 2023 sales
- Jardiance $3,687
- Ofev $1,790
Outcomes Creativity Index Score: 55
- Manny Awards — 7
- Cannes Lions — N/A
- Clio Health — N/A
- Creative Floor Awards — N/A
- LIA: Pharma/Health & Wellness – 24
- MM+M Awards — 12
- One Show — 12
For Boehringer Ingelheim 2022 was an important year,” according to Hubertus von Baumbach, chairman of the board of managing directors; Carinne Brouillon, member of the board of managing directors with responsibility for the Human Pharma Business Unit; Dr. Michel Pairet, member of the board of managing directors with responsibility for the Innovation Unit; and Jean Scheftsik de Szolnok, member of the board of managing directors with responsibility for the Animal Health business.
These managing directors say they were determined not to let market uncertainties slow down the progress in the company’s growing pipeline. “In 2022 alone, we reached one FDA Breakthrough Designation, three Fast Track Designations, and two Orphan Drug Designations,” they state.
Among the family-owned company’s 2022 accomplishments was the launch of Spevigo, a monoclonal antibody for treating generalized pustular psoriasis. Boehringer Ingelheim also received approval for Jardiance to treat symptomatic chronic heart failure patients. In addition, the company provided evidence that patients living with chronic kidney disease significantly benefit from Jardiance.
“We delivered promising research results in key medical areas including oncology, the central nervous system, retinal health, and in metabolism,” the managing directors say. “We are currently pursuing clinical proof for more than 50 new medical products. Over the next seven years, we expect 20 new medicine approvals that will help us address unmet needs for many more patients. We will also launch a range of new products for animals from 2023 onwards.
“The excitement about our growing pipeline and the success of our current portfolio, for patients and animals alike, makes us confident about the future, energized to transform lives for generations and reach even more people who benefit from our products.”
According to Christian Boehringer, chairman of the shareholders committee, “2022 was a year that brought positivity after two pandemic COVID-19 years. People were looking forward to meeting again and reconnecting. Our company culture thrives on in-person interactions. Unfortunately, the year also brought war to Europe causing rising energy prices, sharp increases in cost of living, and geopolitical tensions to escalate.”
Despite these challenges, Boehringer says the company entered 2023 with optimism.
2023 marks a shift in some of the company’s management. In December 2022, the company announced two new appointments to the board of managing directors, to replace Pairet and de Szolnok in 2024. Paola Casarosa was appointed with effect July 1, 2023, with responsibility for the Innovation Unit starting January 1, 2024. Prior to this role, she held various leadership roles in business development and in Research. Casarosa is an Italian national, holds a Ph.D. in molecular pharmacology, and a masters’ degree in medicinal chemistry.
Shashank Deshpande was appointed with effect September 1, 2023, with responsibility for the Animal Health Business Unit beginning January 1, 2024. Shashank joined Boehringer Ingelheim in 2012 and was country managing director, Japan. Prior to this role he held several leadership and marketing positions in Japan and Ingelheim. A German and U.S. national, Deshpande holds a masters’ degree in business administration.
Financial & product performance
“Our businesses performed well in 2022,” managing directors say. “In Human Pharma we saw ongoing strong demand for our innovative medications, led by the Jardiance product portfolio and the respiratory medicine Ofev. Our Animal Health business felt the impact of the economic slowdown in Europe and North America, while at the same time laying the groundwork for a range of new product launches.”
The company generated sales of €24.15 ($25.35 billion) in 2022, 17 percent more than in 2021. Net income was €3.18 billion ($3.35 billion), a decrease of 6.6 percent. Executives attribute the decrease to withdrawals from group equity of €225 million ($237 million) due to a slightly higher tax rate in Germany.
The company achieved net sales growth in every region, with the Americas being Boehringer Ingelheim’s key sales market. Sales grew in this market by 25.4 percent to €11.47 billion ($12.08 billion).
Sales in Europe also improved, climbing by 15.1 percent to €7.54 billion ($7.95 billion). Executives attribute this growth to the global in-licensing business allocated to this region as well as the markets in Germany, Spain, and Eastern Europe.
2022 sales in the Asia/Australia/Africa region increased 4.5 percent to €5.14 billion ($5.41 billion).
Boehringer Ingelheim has three businesses: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. The company’s largest unit by sales is Human Pharma, which generated €18.46 billion ($19.45 billion), an increase of 20.7 percent from 2021. This unit accounted for 76.5 percent of the company’s net sales in 2022. Regionally, the United States was Human Pharma’s largest revenue contributor, executives say, with sales of €7.5 billion ($7.9 billion), an increase of 29.8 percent. This represents an almost 41 percent share of the business’s overall net sales, executives say.
In the EUCAN region (Europe and Canada), Human Pharma sales were €5.93 billion ($6.25 billion), 19 percent more than in 2021. The region constituted 32.1 percent of the group’s 2022 sales.
Sales in Emerging Markets were €3.7 billion ($3.9 billion) in 2022, a growth rate of 15.8 percent. “The market in China remained challenging in 2022 due to volume-based procurement mechanisms as well as COVID-19 lockdowns in part and was only able to record slight sales growth of 1.2 percent compared to the previous year due to favorable exchange rates,” executives state.
Japan accounted for sales of €1.33 billion ($1.4 billion), or 7 percent, of the Human Pharma sales. In this region, sales fell by 0.6 percent due to the “significantly weaker” Japanese yen compared to the euro, executives say.
The type 2 diabetes and heart failure drug Jardiance was Boehringer Ingelheim’s top-selling product in 2022. The drug generated €5.83 billion ($6.14 billion), 48 percent more than in 2021.
Ofev, for treating idiopathic pulmonary fibrosis, was the company’s next best-seller, with 2022 sales of €3.23 billion ($3.4 billion), an increase of 29.5 percent from the previous year.
Trajenta/Jentadueto, for type 2 diabetes, was the third best-seller at €1.7 billion ($1.79 billion, an increase of 9.7 percent compared with 2021 sales.
Sales of the COPD drug Spiriva were €1.56 billion ($1.64 billion) in 2022, about the same as in 2021. According to executives, “Sales developed in line with the product life cycle.”
The fifth best-selling product for Boehringer Ingelheim in 2022 was the anticoagulant Pradaxa. Sales of the drug fell 15.9 percent to €1.11 billion ($1.17 billion), due to generic erosion.
Executives report the company generated a 66.5 percent increase in net sales for the plaque psoriasis and psoriatic arthritis drug Skyrizi, which is marketed globally by partner AbbVie (see profile on page 19). The sales volume in 2022 also includes related non-reoccurring milestone payments.
The company’s Animal Health business increased 6.1 percent to €4.56 billion ($4.8 billion) in 2022, constituting 18.1 percent of total sales. The top product was the NexGard family of antiparasitic products, which generated sales of €1.06 billion ($1.12 billion), 16.2 percent more than in 2021. Growth was attributed to NexGard Spectra and NexGard Combo.
Next in sales is the antiparasitic Frontline, which recorded a sales decrease of 4.1 percent to €401 million ($422 million) in 2022. HeartGard sales were €323 million ($340 million), up 5.2 percent from 2021 as reported but down 5.2 percent when adjusted for exchange rates. Executives attributed the decreases in sales of both products to increased competition and higher inflation, particularly in the United States, which has forced pet owners to prioritize other items in their household budgets.
Sales of the Ingelvac Circoflex swine vaccine also decreased in 2022, to €236 million ($249 million), 6.7 percent less than in 2021. This was due to the difficult market environment in China, executives stated.
Regionally, the United States was the sales leader for this business group in 2022, generating €2.02 billion ($2.12 billion), 10.8 percent more than in the previous year.
The EUCAN region also saw sales rise, at €1.22 billion ($1.38 billion), 3.3 percent more than in 2021. Sales were hindered by the war between Russia and Ukraine as well as supply difficulties in the pet and poultry business in Europe.
The ALAMEA (Asia, Latin America, Middle East, and Africa) region reported sales of €1.04 billion ($1.09 billion), an increase of 8.4 percent. Sales were higher in the pet segment than in the livestock segment, executives say.
Sales in TCM (the Chinese market) region fell by 15.2 percent from 2021, to €290 million ($305 million). Executives attribute this decline to China’s zero COVID policy, numerous lockdowns, and a difficult market in the swine segment, with high costs and low prices.
Biopharmaceutical Contract Manufacturing sales rose 11.7 percent in 2022 to €1.02 billion ($1.08 billion). Executives report the increase was due to strong demand for the products marketed by Boehringer Ingelheim’s business partners. The unit’s focus last year was on product and process transfers to the company’s new manufacturing facility in Vienna.
For the first half of the year, executives say the company had six-month 2023 sales of €12.2 billion ($12.86 billion), 9.7 percent more than in the same period last year. Executives say sales were driven by high demand for medications, with particularly strong momentum for Jardiance in Human Pharma and NexGard in Animal Health.
Net sales in Human Pharma were up 11.3 percent on a currency-adjusted basis at €9.6 billion ($10.11 billion), mainly driven by the Jardiance family at €3.5 billion ($3.69 billion) and the Ofev at €1.7 billion ($1.79 billion).
Executives expect sales of Jardiance to grow following additional regulatory action for treatment of chronic kidney disease. “With the addition to existing indications in type 2 diabetes and heart failure, Jardiance will potentially be able to help manage cardio-renal-metabolic conditions. Over 1 billion people live with cardio-renal-metabolic conditions globally.”
Animal Health recorded growth in Pets and Livestock, with sales increasing by 3.8 percent (currency-adjusted) to €2.5 billion ($2.63 billion) in the first six months of the year. Net sales of NexGard increased 9.2 percent (currency-adjusted) to €644 million ($678 million), while Ingelvac Circoflex rose 8.7 percent to €127 million ($138 million).
In addition, the company complemented its market-leading NexGard portfolio through FDA approvals for NexGard PLUS, a new monthly combination product for dogs that protects against fleas, ticks, heartworm disease, roundworms, and hookworms, and NexGard COMBO, the first-and-only feline broad-spectrum parasite protection that treats tapeworms.
According to executives, Boehringer Ingelheim aims to achieve more than 30 new medical approvals in Human Pharma by 2029 and expects around 20 product launches in Animal Health through 2025.
Pipeline progress & clinical advances
In 2022, Boehringer Ingelheim spent €5.05 billion ($5.32 billion) on research and development, an increase of 22.3 percent more than in 2021. Executives say €4.6 billion ($4.8 billion) of that was spent in the Human Pharma segment.
When it comes to expanding its pipeline, the company has many long-term collaborations, including more than 150 joint projects with over 120 academic institutions. Executives say one long-term objective is that the company will have at least 30 percent of its pipeline to be based on external innovation.
One of the company’s moves in 2022 was partnering with bioMerieux and Evotec SE to launch Aurobac Therapeutics SAS. The goals of this company are to develop novel antibiotics and combat antibiotic resistance.
In 2022, executives report the Human Pharma portfolio had about 90 new clinical and preclinical programs based on more than 50 new molecules. The company has programs in cardiometabolic diseases, oncology, respiratory diseases, immunology, and diseases of the central nervous system (CNS).
Pipeline progress continues in 2023. In August, the company reported that it would advance survodutide into three global Phase III studies in obesity. The decision was based on a Phase II study that showed the glucagon/GLP-1 receptor dual agonist demonstrated up to 19 percent weight loss after 46 weeks of treatment.
“With a strong heritage in cardio-renal-metabolic disease, we are continuing to expand and accelerate our portfolio in this area with the aim of bringing survodutide to patients in need as quickly as possible,” Brouillon stated. “There is a significant unmet medical need for effective treatments for obesity. With its dual mode of action, survodutide has the potential to further improve outcomes for people living with the disease and its associated complications.”
Insights from the previous studies are being applied to the design of the three global Phase III studies, which will investigate the efficacy and safety of survodutide. Enrollment of patients is planned before the end of 2023.
In oncology, the company’s MDM2-p53 antagonist brigimadlin has advanced into the pivotal trial for the treatment of de-differentiated liposarcoma, a rare cancer with limited treatment options so far. The clinical development of two additional investigational therapies (zongertinib, also known as BI 1810631, and BI 764532) from the oncology pipeline has been accelerated based upon positive early clinical data.
The PDE4B inhibitor BI 1015550 is now in two clinical Phase III trials for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis. Patient recruitment for trial investigating BI 1015550 in IPF is well ahead of plan, executives say.
“We have become very successful in bringing new products through our pipeline addressing patients’ needs faster,” says Michael Schmelmer, member of the board of managing directors, responsible for Finance & Group Functions. “We expect to further increase our R&D spending as clinical trials progress into late-stage phases.”
In July, the European Commission approved Jardiance for the treatment of adults with chronic kidney disease (CKD). Executives say the approval has the potential to advance the standard of care for more than 47 million people in the EU living with CKD and help relieve burden on healthcare systems by reducing the risk of all-cause hospitalization for people with CKD.
The approval is based on results from EMPA-KIDNEY, the largest and broadest dedicated SGLT2 inhibitor trial in CKD to date, which showed a significant benefit of empagliflozin in reducing the relative risk of kidney disease progression or cardiovascular death by 28 percent vs. placebo in people with chronic kidney disease.
The trial also demonstrated a statistically significant relative risk reduction in hospitalization for any cause by 14 percent vs. placebo. CKD doubles a person’s risk for hospitalization and is a leading cause of death globally. In the EU, hospitalizations account for up to 70 percent of total healthcare costs for people with CKD.
“Living with chronic kidney disease can have a drastic impact on patients and their family’s lives. CKD not only affects individuals but also society overall due to the high economic burden to healthcare systems,” Brouillon stated. “As we deepen our knowledge in interconnected cardio-renal-metabolic conditions, we are very excited about the approval and the potential for empagliflozin to play an essential role in helping patients, their physicians, and healthcare systems.”
Also in July at the 25th World Congress of Dermatology, the company presented late-breaking data from the EFFISAYIL 2 trial showing that Spevigo significantly reduced the risk of generalized pustular psoriasis flares by 84 percent over 48 weeks compared to placebo. Furthermore, the trial with 123 patients demonstrated no flares after Week 4 of spesolimab treatment in the high dose group.
“Through our comprehensive EFFISAYIL clinical program we have already delivered spesolimab as a major advancement for flaring GPP patients,” Brouillon says. “The EFFISAYIL 2 trial results build on this success bringing us closer to achieving our ultimate goal of a flare-free future for everyone living with GPP.”
In May, Boehringer Ingelheim launched clinical development of its first-in-class IL-11 inhibitor antibody BI 765423 for fibrotic diseases, with a Phase 1 study (NCT05658107) to assess the safety, tolerability, and pharmacokinetics in healthy volunteers.
“The initiation of this trial is an important milestone for Boehringer Ingelheim and brings us closer to achieving our aim of transforming lives of people living with fibrotic diseases,” says Clive R. Wood, Ph.D., corporate senior VP and global head of discovery research at Boehringer Ingelheim. “The effects shown for anti-IL-11 preclinically are impressive and could, if confirmed in the clinic, herald a dramatic advance in the treatment of fibrotic diseases.”
The IL-11 program complements Boehringer Ingelheim’s clinical fibrotic disease pipeline portfolio, which includes BI 1015550, a phosphodiesterase 4B (PDE4B) inhibitor. This drug is under investigation in two Phase III randomized, double-blind, placebo-controlled trials – FIBRONEER-IPF (NCT05321069) and FIBRONEER-ILD (NCT05321082) – to investigate the efficacy, safety, and tolerability of BI 1015550 over at least 52 weeks in patients with idiopathic pulmonary fibrosis and in patients with other progressive fibrosing ILDs and several other clinical stage programs.
To further its research capacity, in April Boehringer Ingelheim inaugurated its state-of-the-art Biologicals Development Center in Biberach, Germany. Executives say the new high-tech facility underlines the company’s strong commitment to Germany and Europe as location for research and development (R&D) for the care of patients around the world.
According to leaders, with the investment of €350 million ($369 million), Boehringer Ingelheim significantly enhances its innovation power and development of biopharmaceutical development capabilities in Germany.
“For many severe diseases with insufficient therapeutic options, highly complex biopharmaceutical molecules continue to give many patients great hope for treatment,” von Baumbach says. “In our new development center, we will conduct cutting-edge research at the most advanced level to achieve therapeutic breakthroughs. This sets a benchmark for the industry and serves as an essential addition to our global biopharmaceutical R&D network.”
In January, Boehringer Ingelheim and 3T Biosciences entered into a strategic collaboration and licensing agreement to discover and develop next-generation cancer therapies to address high unmet patient needs. According to company leaders, the partnership will bring together 3T Biosciences’ best-in-class 3T-TRACE (T-Cell Receptor Antigen and Cross-Reactivity Engine) discovery platform with Boehringer Ingelheim’s two-pronged research strategy combining cancer cell-directed and immune cell-
targeting compounds, further strengthening the company’s pipeline.
“Cancer immunotherapies have brought dramatic breakthroughs, but only for a minority of cancer patients,” executives say. “3T‘s platform aims to address this challenge by identifying novel shared T-cell receptor (TCR) targets of productive immune responses and comprehensively screening TCRs and TCR mimetics for specificity and off-target cross-reactivities. The platform identifies the most prevalent and immunogenic targets in solid tumors by uniquely combining high-diversity target libraries with active machine learning. This may lead to tumor-specific, safer therapies that can be delivered at higher doses.”
“At Boehringer Ingelheim, we are committed to transforming patients’ lives,” says Lamine Mbow, Ph.D., global head of Cancer Immunology + Immune Modulation, Boehringer Ingelheim. “Through our new partnership with 3T Biosciences, we aim at accelerating and expanding our pipeline of first-in-class T-cell based therapies for patients affected by cancer.”
“3T’s 3T-TRACE discovery platform has the potential to transform the treatment of cancers and beyond,” says Stefan J. Scherer, M.D., Ph.D., president and CEO of 3T Biosciences. “By using data from patients for patients we aim to discover the best immunogenic targets for multiple tumor indications and across patient populations.”