StemCell Therapy

By Bill Berkrot

(Reuters) - Eli Lilly and Co on Tuesday provided no new information on how long U.S. regulators might delay approval of its closely watched rheumatoid arthritis drug after its surprise rejection by the Food and Drug Administration this month.

Lilly shares, which have outperformed its rivals this year, fell 3 percent to $80.83 even though the U.S. drugmaker reported a slightly higher-than-expected quarterly profit.

"Maybe people are trying to understand where the near-term upside is going to come from," said Credit Suisse analyst Vamil Divan, adding that investors may be taking profit while waiting for clarity on baricitinib.

Lilly reiterated that it was disappointed and disagreed with the FDA assessment on baricitinib, particularly since the medicine won European approval. It said it hoped in the next 60 days to meet with the agency, which had requested more data.

On a conference call with analysts, Lilly was asked whether it was likely in 2017 or 2018 to satisfy FDA concerns outlined in the letter denying approval.

"We can't give an estimate on this year or next until we meet with the FDA," said Christi Shaw, head of Lilly Bio-Medicines.

The FDA asked for more data on proper dosing and safety information on the medicine developed with Incyte Corp.

Lilly expressed confidence it could attain its minimum goal of 5 percent annual revenue growth even without baricitinib approval this year.

Excluding special items, Lilly said it earned 98 cents per share in the first quarter, topping the analysts' average estimate by 2 cents, according to Thomson Reuters I/B/E/S.

Guggenheim Securities analyst Tony Butler said the results benefited from an animal health acquisition, which "makes the beat look less glamorous."

He did call sales of newer diabetes drug Trulicity "tremendous." If baricitinib was approved, he added, "I don't think the stock would be down."

Trulicity, which competes with Novo Nordisk blockbuster Victoza, brought in $372.9 million in the quarter, well ahead of Wall Street estimates of about $328 million.

Lilly maintained its full-year forecast for earnings of $4.05 to $4.15 per share, excluding items.

Revenue rose 7.5 percent to $5.23 billion, roughly in line with expectations.

Other new products with strong sales included Taltz for psoriasis and cancer drug Cyramza. The company called Cyramza sales for gastric cancer in Japan "phenomenal" but acknowledged competitive challenges from immuno-oncology drugs for lung cancer in the United States.

(Reporting by Bill Berkrot in New York and Ankur Banerjee in Bengaluru; Editing by Lisa Von Ahn)

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Lilly gives no time frame on arthritis drug delay; shares fall - Yahoo Finance

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