FibroGen Tumbles on Earnings Miss, FDA Meeting Notice

FibroGen shares are lower after the FDA says it wants to discuss the company's kidney-disease treatment. One analyst says investors should buy the dip.
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FibroGen  (FGEN) - Get Report shares dropped on Tuesday after the biotech posted a wider-than-expected fourth-quarter loss and reported that regulators would convene an advisory meeting to discuss the kidney disease treatment roxadustat.

Shares of the San Francisco company at last check were off 32% at $34.33.

FibroGen and AstraZeneca  (AZN) - Get Report, its partner on roxadustat, said the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee will meet to review their new-drug application for roxadustat in the U.S. 

The companies said they had not received a confirmed meeting date from the FDA.

"While disappointed with the news today, FibroGen and AstraZeneca are committed to working with the FDA to bring roxadustat to patients with anemia of (chronic kidney disease) in the U.S. as soon as possible,” FibroGen Chief Executive Enrique Conterno said in a statement.

Roxadustat has been approved in China, Japan and Chile to treat anemia of chronic kidney disease in both non-dialysis-dependent and dialysis-dependent adults.

Jefferies analyst Michael Yee downgraded FibroGen to hold from buy with a price target of $45, down from $75, after the FDA said that it planned to hold the advisory meeting for roxadustat. 

Yee said in a note to investors that the FDA meeting meant the drug wouldn't be cleared in the near term.

The analyst said his base case now is an advisory committee meeting being held this summer, with a regulatory decision by year end.

Citi analyst Joel Beatty said that while this "unusual last-minute decision" by the FDA will raise questions among investors, they should buy the dip. 

Beatty, who a keeps a buy rating on the shares with a $51 price target, said he believes FibroGen will trade higher once an advisory committee date is announced, "which should help investors get a little more confidence that an outright CRL (complete response letter) is unlikely." 

Separately, FibroGen reported a fourth-quarter loss of $58.6 million, or 64 cents a share, compared with a net loss of $98.1 million, or $1.12, in the year-earlier quarter.

The FactSet analyst consensus had called for a loss of 23 cents a share. 

Revenue totaled $65 million, compared with $8 million a year ago. The latest figure missed the FactSet forecast of $100.8 million.