IDNA - Intercept: Increase Of Ocaliva Sales And A Few Catalysts

• Final data from the phase 3 REGENERATE study, using Ocaliva for the treatment of patients with NASH fibrosis, is expected any day now.
• If all goes well with clinical data, Intercept expects a pre-submission meeting with the FDA in June of 2022.
• Results from the phase 3 REVERSE study using Ocaliva for the treatment of patients with compensated cirrhosis due to NASH are expected in Q3 of 2022.
• Two studies are being done testing the fixed dose combination of Ocaliva and bezafibrate for the treatment of patients with primary biliary cholangitis.
• Licensing deal made with Advanz Pharma for Ocaliva brought in $405 million as an upfront payment and the potential to earn $45 million upon a condition being met; from there, it will be eligible for royalties on net sales.

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