- Intercept Pharmaceuticals Inc ICPT completed the sale of its international business for $405 million in upfront consideration.
- The company held a pre-submission meeting with FDA in July and plans to resubmit the marketing application NDA for OCA in fibrosis due to NASH by the end of 2022.
- Q2 Ocaliva adjusted net sales in PBC reached $100.4 million. The U.S. net sales of $71.8 million, +5% Y/Y.
- The company reported a net loss of $(7.5) million, a decrease compared to a net loss of $(11.1) million in Q2 FY21.
- ICPT held cash, cash equivalents, restricted cash, and investment debt securities for sale of approximately $412.3 million.
- Guidance: After suspending guidance due to the impact and lack of clarity on the timing for closing the sale of international business, ICPT reissued FY22 Ocaliva adjusted sales guidance of $325 million - $345 million from $375 million - $405 million.
- It reissued adjusted operating expense guidance of $335 million - $365 million from $360 million - $390 million.
- Price Action: ICPT shares are up 13.7% at $13.93 during the market session on the last check Wednesday.
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