2019 revenue: $21.28 billion
2018 revenue: $20.67 billion
Headquarters: Ingelheim, Germany
When Germany’s Boehringer Ingelheim started losing patent protection on its blockbuster COPD and asthma drug Spiriva in 2017, it wasn’t clear how the closely held company would make up for the loss.
As it turns out, a valuable diabetes partnership with Eli Lilly has been a critical cushion for BI.
BI reported (PDF) that in 2019, its sales of the Lilly-partnered SGLT2 diabetes drug Jardiance skyrocketed 47% $2.41 billion. That helped soften the blow from the Spiriva revenues that were lost to generic competition, causing sales of that product to fall nearly 15% to $2.3 billion.
The key to Jardiance’s success has been BI and Lilly’s ability to use real-world data to prove that the drug has heart-boosting benefits. Last November, for example, the companies released three-year data from their Emprise study showing that Jardiance significantly reduced the risk of hospitalizations for heart failure. In fact, compared to DPP-4 inhibitors such as Merck’s Januvia and AstraZeneca’s Onglyza, Jardiance reduced the risk of hospitalization by a whopping 41%.
The Emprise results were like an exclamation point on Jardiance’s Empa-Reg outcomes study, which reported a 35% cardiovascular risk reduction for Type 2 diabetes patients taking the drug versus those on a placebo.
But it wasn’t just Jardiance that turned in an impressive performance for BI last year. Sales of Ofev, its idiopathic pulmonary fibrosis (IPF) drug, grew 31.6% to $1.67 billion. BI also won a second approval for the drug in systemic sclerosis from interstitial lung disease (SSc-ILD). Last year, the company made strides toward extending the product’s label into other rare conditions. In October, it released phase 3 trial data showing that Ofev slowed the decline of lung function in patients with non-IPF interstitial lung diseases by 57% over placebo after one year. The trial included patients with SSc-ILD, as well as those with a wide range of related disorders.
In 2016, when many of its rivals were exiting animal health, BI bulked up its veterinary offerings by executing a $12.5 billion asset swap with Sanofi—a move that has certainly paid off for the German drugmaker. In 2019, BI snagged 200 product approvals in animal health, including European approval for Arti-Cell Forte, a stem-cell treatment for lameness in horses.
Sales of BI’s top animal health product, Nexgard—the chewable flea-and-tick fighter for dogs—jumped 21% to $828.8 million in 2019. That helped drive sales in the animal health unit up nearly 2% for the year to $4.5 billion.
BI has also made a major push into contract manufacturing for biotech products. It established manufacturing sites in Germany, Austria and the U.S. before teaming up with Zhangjiang Biotech & Pharmaceutical Base Development Company (ZJ Base) in Shanghai in 2013.
BI opened up the first phase of the $77 million China facility in 2017. Now its bet on China is paying off, as the facility is on tap for manufacturing BeiGene’s monoclonal antibody tislelizumab, an anti-PD-1 checkpoint inhibitor to treat cancer. All told, sales in the company’s biopharmaceutical contract manufacturing unit rose 7.1% in 2019 to $880 million.
BI is facing plenty of challenges. In November, BI and Lilly rejiggered their alliance, which initially included the DPP-4 diabetes treatment Trajenta and the insulin product Basaglar. Now BI has total control over Trajenta, a drug that notched $1.75 billion in sales for the company last year. But Basaglar is moving over to Lilly, and Trajenta is set to lose its patent protection in 2023.
And now, BI has to face fresh competition for high-flying Jardiance. In September, the FDA approved Novo Nordisk’s Rybelsus, the first oral GLP-1 diabetes treatment.
BI and Lilly hope their strategy of continuing to prove Jardiance’s benefits will help the product weather the competition. After the companies rolled out data showing the drug lessens the risk of new or worsening kidney disease, the FDA fast-tracked its review of an expanded label that would state that Jardiance reduces the risk of kidney progression and cardiovascular death in patients with chronic kidney disease.