ITCI - Bull Thesis

(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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