16. Boehringer Ingelheim

Boehringer
Boehringer Ingelheim eked out sales growth in the first half of 2020, buoyed by pandemic-bucking performances from Type 2 diabetes med Jardiance and idiopathic pulmonary fibrosis drug Ofev. (Boehringer Ingelheim)

Boehringer Ingelheim
2020 revenue
: $22.29 billion (converted from €19.56 billion)
2019 revenue: $21.64 billion (converted from €18.99 billion)
Headquarters: Ingelheim, Germany

The story of Boehringer Ingelheim in 2020 is in many ways the story of Jardiance—the Lilly-partnered SGLT2 diabetes drug that's helped defend the company's top line as Boehringer faces generic competition on blockbuster COPD and asthma drug Spiriva.

Even as the COVID-19 pandemic tore a chunk out of sales for countless meds last year, Boehringer Ingelheim managed not only to stay afloat, but drove revenues up 3% to $22.29 billion. Adjusted for foreign currencies, net sales climbed 5.6% year over year, according to the company's annual report (PDF).

The performance came thanks in no small part to its Type 2 diabetes portfolio and, in particular, its blockbuster Jardiance, whose 2020 sales grew 15% to $2.82 billion. Jardiance sales checked in at around $2.4 billion in 2019. 

RELATED: Boehringer Ingelheim quietly culls decades-old hypertension med after October recall

Over the course of the year, BI's med, hot on the trail of AstraZeneca rival Farxiga, made strides in heart failure, though not without some missteps in diabetes along the way. 

The FDA in March slapped Lilly and BI with a complete response letter in type 1 diabetes, rejecting a 2.5-milligram dose of empagliflozin plus insulin in the disease. While unfortunate for BI, the move didn't come as a total shock: An FDA advisory committee in November 2019 voted 14-2 against the company's application, citing a lack of clinical data. Lilly and BI had hoped to take Jardiance into Type 1 under a different brand name.

Things started to look up by summer, as the partners turned out top line data showing Jardiance bested placebo at cutting the risks of cardiovascular death and hospitalization in heart failure patients with or without Type 2 diabetes. 

The data inched Lilly and BI's Jardiance one step closer to an approval in heart failure patients with a reduced ejection fraction (HFrEF) and came just after AZ's Farxiga became the first SGLT2 inhibitor to win an FDA approval in that indication in May. 

RELATED: AstraZeneca's Farxiga scores a speedy FDA review in kidney disease—and gets another jump on rival Jardiance

A month later, BI and Lilly bolstered their case, presenting full data at the European Society of Cardiology virtual annual meeting that showed Jardiance on top of standard care slashed the risk of cardiovascular hospitalizations or death by 25% over placebo in heart failure patients with or without Type 2 diabetes.

In data from the partners' phase 3 Emperor-Reduced trial, once-daily Jardiance lowered the risk of cardiovascular events after 16 months and also reduced the average number of total hospitalizations in trial subjects by 30% over placebo. The drug also improved kidney function by 50%.

The other drug that kept BI's pharma sales churning in 2020 was idiopathic pulmonary fibrosis med Ofev. The drug posted a sales increase of 38% to $2.34 billion, BI said.

The company has sought to carve out a sales niche for Ofev in a wide swath of ultrarare lung diseases, capitalizing on those ambitions in February with an expanded FDA nod to treat patients with a range of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. The approval covers between 18% and 32% of total patients with an ILD, which includes around 200 diseases that can lead to irreversible scarring of lung tissue, BI said at the time.

RELATED: BI, Gilead execs highlight value of disease awareness campaigns—particularly during the pandemic

Meanwhile, Boehringer's bet on China paid off in early 2020. The Chinese unit of the German drugmaker last January became the first CDMO to crank out an approved drug under the country’s Marketing Authorization Holder (MAH) system. Specifically, BI manufactured the monoclonal antibody tislelizumab, BeiGene's anti-PD-1 checkpoint inhibitor.

The company opened the first phase of its $77 million China plant in 2017, armed with a single-use bioreactor capable of handling clinical supplies or commercial production up to 2,000 liters. BI designed the plant so that additional 2,000-liter single-use bioreactors and fill-finish capabilities can be added according to demand. 

The company's China presence also meant BI had its finger on the pulse when the novel coronavirus started to spread last winter. In late February, as the industry and the world at large were coming to grips with the pandemic, BI was among a suite of pharma majors, including Bristol-Myers Squibb, GlaxoSmithKline, Mylan, Novartis, Sanofi and more, to ask its employees in the region to “reschedule business meetings that require traveling or organize them virtually in those areas." 

16. Boehringer Ingelheim