ITCI - Bull Thesis
(Last updated 3/18/22)
BULL THESIS SUMMARY
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
FS/MV 3/18/22
(See below for full updated bull/bear analysis)
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 3/18/202
(Historial analysis from 12/31/2021)
BULL THESIS
ITCI overall corporate
ITCI currently has no debt
ITCI has enough cash for over one and a half years
CAPLYTA is ITCI’s first approved therapeutic with ~80M annual revenue from its 1st approved indication (schizophrenia) and has a very favorable safety profile for an efficacious mental health therapy
CAPLYTA was recently (Dec 2021) approved for bipolar disorder, a much larger market than schizophrenia, and has multiple opportunities for expansion into additional indications/markets
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)
>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 schizenophrenia and Bipolar (at 42 mg dose)
Consistent revenue and prescription ramp since launch - even while launched during the COVID pandemic
CAPLYTA is now approved and has the 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
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
ITI-333 Ph1 results in second half of 2021
FS/MV 12/31/21
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