- Intercept Pharmaceuticals Inc ICPT reported Q3 sales of $92.8 million, up 17% Y/Y, surpassing the consensus of $83.02 million.
- Ocaliva net sales comprised U.S. net sales of $66.6 million and ex-U.S. net sales of $26.2 million, compared to $58.6 million and $20.9 million a year ago.
- The Company expects topline results from the Phase 3 REVERSE study in compensated cirrhosis due to NASH by the end of 2021.
- Intercept is also compiling a new data package from the Phase 3 REGENERATE study in fibrosis due to NASH to support a potential resubmission meeting with the FDA in 1H of 2022.
- R&D expenses decreased to $45.0 million from $48.9 million in the prior-year quarter, primarily driven by lower personnel and development costs.
- SG&A expenses decreased to $53.3 million from $70.6 million, primarily driven by actions taken to reduce costs relating to launching preparation activities associated with the potential approval and commercialization of OCA for liver fibrosis due to NASH.
- The Company posted a narrower net loss of $3.6 million, compared to $66.5 million a year ago.
- ICPT ended Q3 with cash, cash equivalents, restricted cash, and investment debt securities available for sale of approximately $428.8 million.
- Guidance: Intercept raised FY21 Ocaliva net sales guidance to $355 million - $370 million from $325 million - $340 million.
- The Company also narrowed adjusted operating expense guidance to $380 million - $395 million from $380 million - $410 million.
- Price Action: ICPT shares are up 10.5% at $19.28 during the market session on the last check Wednesday.
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