FibroGen (FGEN) Misses Q3 EPS by 2c, Revenues Miss

November 11, 2019 4:04 PM EST

FibroGen (NASDAQ: FGEN) reported Q3 EPS of ($0.57), $0.02 worse than the analyst estimate of ($0.55). Revenue for the quarter came in at $33.17 million versus the consensus estimate of $31.6 million.

“The FibroGen team achieved many milestones over the past few months, culminating with the positive Phase 3 results for roxadustat reported at the American Society of Nephrology conference last week in Washington, D.C.,” said Jim Schoeneck, Interim Chief Executive Officer, FibroGen. “This set of global studies covered the spectrum of chronic kidney disease anemia and is believed to be the largest and most comprehensive ever reported. We expect the positive cardiovascular safety data, comparing roxadustat to placebo in non-dialysis patients and to epoetin alfa in patients on dialysis, along with the superior efficacy results, can serve as the basis for regulatory approval in the U.S. and other jurisdictions. We plan to submit an NDA in the U.S. by the end of this quarter for both dialysis and non-dialysis patients with our partner AstraZeneca, and an MAA in Europe by the end of first quarter 2020 by our partner Astellas, followed by submissions to other regulatory authorities.

“In addition, roxadustat is now approved for CKD patients with anemia in China and was approved in Japan for anemia in CKD patients on dialysis. Our other clinical programs advanced, as we initiated our roxadustat Phase 2 study to treat anemia in patients receiving chemotherapy and enrolled the first patients in our pamrevlumab Phase 3 programs for both idiopathic pulmonary fibrosis (ZEPHYRUS) and locally advanced pancreatic cancer (LAPIS).

“These major accomplishments demonstrate our commitment to the vision set by FibroGen’s founder and long-time CEO and Chairman, Tom Neff. We mourn his unexpected passing and are grateful for his leadership and rare ability to recognize and advance scientific innovation.”

For earnings history and earnings-related data on FibroGen (FGEN) click here.

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