ITCI - Bull Thesis
- Amp Team
- Jan 27, 2022
- 2 min read
Updated: Mar 24, 2022
(Updated 3/24/22 based on quarterly report)
BULL THESIS
ITCI overall corporate and executive summary
ITCI currently has no debt
ITCI has enough cash for about one and a half years
CAPLYTA (Lumateperone) is ITCI’s first approved therapeutic and a portfolio in a molecule
~$80M annual revenue from its 1st approved indication (schizophrenia) and has a very favorable safety profile for an efficacious mental health therapy
Continued prescription growth and Q4 increase of 15% from Q3 and 98% increase from Q4 2020
Fourth quarter CAPLYTA sales of $25.5M
18% growth vs Q3 ‘21 and year over year increase of 106%
Recently (Dec 2021) approved for bipolar disorder, a much larger market than schizophrenia
35% total prescription growth in 1st 7 weeks of 2022
Multiple opportunities for expansion into additional indications/markets
Next major clinical readout - major depressive disorder - H2 2022
CAPLYTA (Lumateperone) is an approved therapeutic for schizophrenia in adults and was recently approved for bipolar disorder on 12/20/2021
CAPLYTA (ITCI’s approved product) is approved and has over $20M of quarterly revenue for only its 1st approved indication (schizophrenia)
Quarter-over-quarter prescription growth accelerated following expansion of label
Robust initial prescription update for bipolar disorder
>2.4 million adults in US suffer from schizophrenia and it is currently an unmet medical need
Especially attractive safety profile for a mental health therapeutic
Similar weight change as placebo (mean change of ~7lbs at 1 year)
Extrapyramidal Symptoms (EPS) including akathisia (muscle quivering and restlessness) and dystonia (muscle contractions) similar to placebo, stable symptoms after 1 year
Met primary endpoint in 2 of 3 trials for schizophrenia and Bipolar Disorder (at 42 mg dose)
Consistent revenue and prescription ramp since launch - even though launched during the COVID pandemic
Potential to be approved in numerous additional mental health indications (see below) to increase revenue substantially
Bipolar depression - Approved on 12/20/2021
Only approved therapeutic to cover bipolar I and II as a monotherapy or adjunctive therapy
Bipolar depression is a large market (11M American adults/year)
2 positive Ph3 trials at 42mg
MDD
Phase 3 data in MDD is expected by end of 2022 (BPIQ.com Suspected Mover)
MDD has a prevalence in US of 17.3 million
Few antipsychotics approved for adjunctive treatment of depression
ITCI has additional assets in Ph1 and Ph2 trials that could provide additional value
ITI-1284 (deuterated lumatep) - entering ph2 for dementia and depressive disorders
Lenrispodun (ITI-214) - PDE1 inhibitor to treat Parkinson’s Ph2 starting this year
ITI-333 - treatment for opioid use disorder and associated comorbidities (e.g., depression, anxiety, sleep disorders) without safety and tolerability concerns of opioids
FS/MV 3/18/2022
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