ICPT - Bull Thesis
Last updated 4/1/22 (slight update to fix REGENERATE timing (Q2 2022))
BULL THESIS SUMMARY
ICPT overall corporate and executive summary
Approved drug Ocaliva (OCA) for PBC (liver disease) has performed well
Revenue growth of 16% ‘21 vs. ‘20 ($363.5M vs. $312.7M) and 25% '20 vs. '19 ($312.7M vs. $249.6M)
Strong Q4 ‘21 sales of $92.4M despite 2021 negative label change
Reimbursement for (OCA) is broad >95% of covered lives
OCA is an antifibrotic and only therapy to demonstrate antifibrotic efficacy in a Phase 3 NASH trial
Q2 2022 huge REGENERATE trial Ph3 readout is somewhat derisked in including many more patients for more time and using new consensus biopsy read strategy, vs. prior positive interim readout.
FS/MV 1/14/22 (updated 4/1/22)
(See below for full bull/bear analysis)
BULL THESIS
ICPT overall corporate and executive summary
Approved drug Ocaliva (OCA) for PBC (liver disease) has performed well
Revenue growth of 16% ‘21 vs. ‘20 ($363.5M vs. $312.7M) and 25% '20 vs. '19 ($312.7M vs. $249.6M)
Strong Q4 ‘21 sales of $92.4M despite 2021 negative label change
Reimbursement for (OCA) is broad >95% of covered lives
OCA is an antifibrotic and only therapy to demonstrate antifibrotic efficacy in a Phase 3 NASH trial
Q2 2022 huge REGENERATE trial Ph3 readout is somewhat derisked in including many more patients for more time and using new consensus biopsy read strategy, vs. prior positive interim readout.
Ocaliva (obeticholic acid) (OCA) (FXR agonist)
Approved in PBC
Revenue has been good with over $360M annual in 2021; Almost $93M in Q4 2021 despite 2021 negative label change
First new medicine for PBC in almost 20 years
First FXR agonist approved for liver disease
Patent term extension granted to give coverage out to 2033
Approved in over 40 countries
Broad payer coverage of >95% of covered lives
Long-term safety extension trial showed OCA improved transplant-free survival in patients with PBC
Fibrosis due to NASH
The REGENERATE trial is the first and only positive Phase 3 readout for any drug candidate in this indication
REGENERATE trial readout in Q2 2022 is somewhat derisked
Many more patients/patient years of data and interim data was stat sig
New consensus biopsy read should provide even more stat sig to the data
Positive data would lead to FDA and EMA resubmissions and possible stock run up
Even if only approved in F3 patients first, market opportunity would be very large
Cirrhosis due to NASH
REVERSE trial is only antifibrotic in Phase 3 trials for compensated cirrhosis due to NASH
Expected data in third quarter 2022 will be generated using the new consensus liver biopsy read methods that should increase sensitivity
Previous Phase 2 trial (CONTROL) met primary objective by showing that newly initiated treatment with atorvastatin rapidly reversed OCA-associated increases in LDL to below baseline levels
Phase 3 REGENERATE trial interim analysis showed once-daily OCA 25 mg met the primary endpoint of fibrosis improvement (≥1 stage) for patients with stage 2 or 3 liver fibrosis with no worsening of NASH at the planned 18-month interim analysis with high statistical significance (p=0.0002 vs. placebo)
REGENERATE focuses on patients w/o cirrhosis, but who are at a higher risk for cirrhosis
PSC
Positive Phase 2 results reported at The Liver Meeting 2017
Met primary endpoint of statistically significant reduction in alkaline phosphatase compared to placebo at 24 weeks
FS/MV 1/14/22 (updated 4/1/22)
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