Eli Lilly and Co. said strong results from new drugs helped push second-quarter earnings up 35 percent. But the company warned that its regulatory resubmission of a much-anticipated drug that the FDA rejected earlier this year could require a new clinical trial.
The Indianapolis-based drugmaker on Tuesday posted quarterly profit of $1 billion, or 95 cents a share. Sales for the period were $5.82 billion, up 8 percent.
Lilly said its plans to resubmit a drug for rheumatoid arthritis to the Food and Drug Administration for approval could take up to 18 months. In April, the FDA rejected the drug, called baricitinib, saying it needed substantially more information about the drug’s safety and the best doses. At the time, Lilly said it would work with the FDA to get the drug approved.
Now, however, Lilly says the process will be delayed beyond 2017 and might require another expensive clinical trial. Analysts had projected that the drug would provide up to $2 billion in annual sales.
Quarterly earnings, adjusted for restructuring costs, totaled $1.11 per share. Analysts expected, on average, adjusted earnings of $1.04 per share on $5.59 billion in revenue, according to Zacks Investment Research.
Lilly downgraded guidance for full-year profit to a range of $2.51 to $2.61 a share. The previous guidance, issued in April, was for $2.60 to $2.70 a share.
But the company upgraded both ends of its 2017 adjusted-earnings-per-share forecast range by a nickel. It now expects adjusted earnings to range between $4.10 and $4.20 per share. Analysts expect, on average, adjusted earnings of $4.12 per share, according to FactSet.
The company said revenue growth in the second quarter was driven by strong sales of new products, including the diabetes medicines Trulicity, Basaglar and Jardiance, and the psoriasis drug Taltz.
These increases were partially offset by decreased sales for older products, including erectile dysfunction drug Cialis, schizophrenia drug Zyprexa, cancer drug Alimta and attention deficit hyperactivity disorder drug Strattera.
Operating expenses in the second quarter were flat at $2.958 billion. Research and development expenses decreased 6 percent, to $1.251 billion.
Lilly shares fell 2.6 percent Tuesday in early trading, to $82.46 per share.