On May 10, 2022 Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, reported its financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Intra-Cellular Therapies, MAY 10, 2022, View Source [SID1234614056]).
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"We are encouraged by the robust uptake of CAPLYTA in the first full quarter following our late December 2021 launch in bipolar depression and are confident in our ability to deliver continued strong growth and to improve the lives of patients. We continue to advance our pipeline, including our lumateperone programs in major depressive disorder (MDD) and mixed features," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.
First Quarter Financial Highlights:
Total revenues were $35.0 million for the first quarter of 2022, compared to $15.9 million of total revenues for the first quarter of 2021. Net product revenues of CAPLYTA were $34.8 million for the first quarter of 2022, compared to $15.6 million in net product revenues of CAPLYTA for the same period in 2021, representing a year-over-year increase of 123% and a 36% increase over the fourth quarter of 2021.
Cost of product sales were $3.2 million in the first quarter of 2022, compared to $1.5 million for the first quarter of 2021.
Research and development (R&D) expenses for the first quarter of 2022 were $29.0 million, compared to $15.1 million for the first quarter of 2021. This increase is due to higher lumateperone clinical trial and non-clinical related costs and an increase in non-lumateperone project costs.
Selling, general and administrative (SG&A) expenses were $75.5 million for the first quarter of 2022, compared to $52.6 million for the first quarter of 2021. This increase is primarily due to an increase in commercialization, marketing and labor related costs.
Net loss for the quarter ended March 31, 2022 was $72.1 million, compared to a net loss of $52.7 million for the quarter ended March 31, 2021.
Cash, cash equivalents, restricted cash and investment securities totaled $773.2 million at March 31, 2022, compared to $413.7 million at December 31, 2021. On January 7, 2022, we completed a public offering of our common stock in which we sold approximately 10.95 million shares of common stock for aggregate gross proceeds of $460.0 million and net proceeds, after deducting underwriting discounts and commissions and offering expenses, of approximately $433.7 million.
COMMERCIAL HIGHLIGHTS
CAPLYTA launched in bipolar depression immediately following its U.S. Food and Drug Administration (FDA) approval in late December 2021. CAPLYTA is the first and only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy and as adjunctive therapy with lithium or valproate.
Significant inflection in both new and total prescriptions reflecting robust growth following approval in bipolar depression. First quarter CAPLYTA new and total prescriptions increased by 63% and 45%, respectively, versus the fourth quarter of 2021. First quarter CAPLYTA new and total prescriptions increased by 154% and 134%, respectively, versus the first quarter of 2021.
New-to-brand prescriptions, representing new CAPLYTA patient starts, have increased by approximately 300% following bipolar depression approval. New-to-brand prescriptions are considered a key leading indicator of growth during the launch phase, reflecting early adoption by prescribers. These encouraging uptake trends have been accompanied by positive physician receptivity to CAPLYTA.
CAPLYTA maintained broad coverage in the Medicare Part D and Medicaid channels, with greater than 98% of lives covered and expanded coverage in the commercial channel to over 80% of lives covered. Our LytaLink patient support program continues to be very effective in supporting patient access.
CLINICAL HIGHLIGHTS
Lumateperone:
Received approval by the FDA for two new dosage strengths of CAPLYTA, 10.5 mg and 21 mg capsules, to provide dosage recommendations for patients concomitantly taking strong or moderate CYP3A4 inhibitors, and 21 mg for patients with moderate or severe hepatic impairment (Child-Pugh class B or C). This strengthens CAPLYTA’s overall profile even further by expanding the appropriate patient base within the highly prevalent conditions of bipolar disorder and schizophrenia.
Adjunctive MDD program: Patient enrollment in pivotal studies 501 and 502 is ongoing. These are Phase 3 double blind, placebo-controlled, 6-week global studies evaluating lumateperone 42 mg as adjunctive treatment to anti-depressants. The primary endpoint is change from baseline versus placebo on the MADRS total score at week 6, and the CGI-S scale is the key secondary endpoint. We expect to file a supplemental New Drug Application (sNDA) with the FDA for lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD in 2024.
Mixed Features program: Clinical conduct is ongoing in Study 403, a global clinical trial evaluating lumateperone 42 mg in patients with MDD and in patients with bipolar depression who exhibit mixed features. We expect to complete clinical conduct in this Study in the second half of 2022.
Lumateperone Long Acting Injectable (LLAI) formulation: Initial clinical conduct in our Phase 1 single ascending study has been completed, and we are encouraged by the safety and tolerability results we have seen to date. We are exploring alternate sites of injection with the current formulation as well as progressing the development of other formulations. The goal of our program is to develop LLAI formulations that are effective, safe and well-tolerated with treatment durations of one month and longer. Together, these Phase 1 studies will assist us in designing formulation and dosing strategies for our efficacy studies.
Other Programs:
ITI-1284-ODT-SL program: ITI-1284 ODT-SL Phase 1 studies are either ongoing or planned, including food effect and brain-imaging studies. We expect to commence clinical conduct in our agitation in patients with probable Alzheimer’s disease program in 2022, followed by additional studies in dementia-related psychosis and certain depressive disorders in the elderly. We have previously completed single and multiple ascending dose studies in healthy young and elderly subjects, demonstrating rapid absorption and excellent drug exposure, allowing doses to be selected for our next studies.
Phosphodiesterase type I inhibitor (PDE1) program: Lenrispodun (ITI-214) is our lead compound in this program. We expect to initiate patient enrollment/clinical conduct in our lenrispodun Phase 2 clinical trial for the treatment of Parkinson’s disease in the first half of 2022.
In preclinical studies, we have shown that PDE1 inhibitors can inhibit the recruitment of immune cells such as microglia and macrophages into tumors, thereby altering the tumor microenvironment. We have shown that lenrispodun can potentiate the action of PD-1 inhibitors in various models of colorectal, kidney, breast and glioblastoma cancers. Recently, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, we presented preclinical data describing the antitumor effects of PDE1 inhibitors when administered in conjunction with checkpoint inhibitor immunotherapy in an animal model of breast cancer. Additional data from this program will be presented at upcoming conferences this year.
ITI-333 program in Opioid Use Disorder: Following the positive results from our Phase 1 single ascending dose study evaluating the safety, tolerability and pharmacokinetics of ITI-333 in healthy volunteers, our plan is to advance the development of ITI-333 with neuroimaging studies, followed by a multiple ascending dose study.
Conference Call and Webcast Details
The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company’s financial results and provide a corporate update. The live webcast and subsequent replay may be accessed by visiting the Company’s website at www.intracellulartherapies.com. Please connect to the Company’s website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-(844) 835-6563 (U.S.) or 1-(970) 315-3916 (international) to listen to the live conference call. The conference ID number for the live call is 9526447. Please dial in approximately 10 minutes prior to the call.
CAPLYTA (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. CAPLYTA is available in 42 mg capsules.
Important Safety Information
Boxed Warnings:
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All anti-depressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.
Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.
Warnings & Precautions: Antipsychotic drugs have been reported to cause:
Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors (10.5 mg) or moderate CYP3A4 inhibitors (21 mg).
Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Dose reduction is recommended for patients with moderate or severe hepatic impairment (21 mg).
Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.
Please click here to see full Prescribing Information including Boxed Warning.
About CAPLYTA (lumateperone)
CAPLYTA 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.
Lumateperone is being studied for the treatment of major depressive disorder, and other neuropsychiatric and neurological disorders