What happened
Following years of stagnation, Eli Lilly (LLY +2.55%), a big U.S. pharmaceutical company, produced market-thumping gains last year. According to data from S&P Global Market Intelligence, the stock gained 37% in 2018. Last year it became clear that smart moves in recent years have set the company up for a growth spurt that's long overdue.
Check out the latest Eli Lilly earnings call transcript.
So what
In June the FDA smashed Lilly's hope for significant U.S. sales from its oral rheumatoid arthritis treatment, Olumiant. The FDA approved a dosage considered too low to be effective, limited it to patients resistant to Humira, and slapped a black-box warning on the label.
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Lilly overcame its Olumiant setback with encouraging sales results for products launched since 2014 and a spin-off of its animal health business into a separate company. The Elanco Animal Health (ELAN +2.42%) initial public offering netted $1.7 billion. Lilly still owns around 80% of the spin-off and accepted most of the IPO proceeds as partial consideration for the business Lilly transferred to Elanco.
In addition to the spin-off they wanted, investors were thrilled to see sales of eight drugs launched since 2014 reach $5.1 billion during the first nine months of the year. That was a 65% gain over the previous year, and we could see big gains from Lilly's rookie lineup in 2019.
Now what
In the fourth quarter of 2018, Lilly launched Emgality, a new monthly injection that significantly reduces the number of migraine headaches people suffer. In 2019, the FDA could approve another new drug from Lilly to stop migraine pain after it starts. If the agency green-lights the application Lilly sent in last year, lasmiditan will become the first new acute pain relief option migraine patients have seen in decades.
Emgality will have to tussle with some competition from Amgen and Teva, but that isn't the only drug about to add more than $1 billion to Lilly's top line in 2019. Last February, the FDA expanded Verzenio's label to include newly diagnosed breast cancer patients. Pfizer's Ibrance is a similar therapy that racked up $3 billion in sales during the first nine months of 2018 as a treatment for this group, and Lilly's offering could do just as well.
