Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) is a biopharmaceutical company focused on the discovery, clinical development, and commercialization of innovative, small molecule drugs that address underserved medical needs primarily in psychiatric and neurological disorders. The company's lead product, CAPLYTA® (lumateperone), has seen impressive growth since its approval for the treatment of schizophrenia in adults in 2019 and bipolar depression in adults in 2021.

Financials

In the first quarter of 2024, Intra-Cellular reported total revenues of $144.9 million, a 53% increase from the same period in 2023. This strong performance was driven by robust growth in CAPLYTA net sales, which reached $144.8 million, up from $94.7 million in the prior year quarter. The company's gross-to-net ratio remained in the mid-30s, consistent with its guidance. Intra-Cellular is reiterating its full-year 2024 CAPLYTA net sales guidance of $645 million to $675 million.

The company's financial position remains strong, with $477.4 million in cash, cash equivalents, and investment securities as of March 31, 2024. In April 2024, Intra-Cellular completed a public offering of common stock, raising approximately $543 million in net proceeds, further strengthening its balance sheet and providing ample resources to support its growth initiatives.

Recent Developments

A Major Milestone Achieved with Positive MDD Data

The highlight of the quarter was the announcement of positive topline results from the company's Phase 3 clinical trial, Study 501, evaluating lumateperone as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Lumateperone 42 mg given once daily as adjunctive therapy met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score compared to placebo at Week 6. The study also met the key secondary endpoint, showing a statistically significant and clinically meaningful reduction in the Clinical Global Impression Scale for Severity of Illness (CGI-S) score compared to placebo at Week 6.

These robust results underscore the potential for lumateperone to treat a broad spectrum of mood disorders. Intra-Cellular has now demonstrated lumateperone's strong antidepressant activity in patients with MDD as an adjunctive therapy, as well as in patients with bipolar I and bipolar II, both as a monotherapy and as adjunctive therapy. The company believes these findings, coupled with lumateperone's distinct pharmacology, reinforce its label expansion strategy and the long-term prospects for the drug across mood disorders.

Expanding the Addressable Market for CAPLYTA

With the positive MDD data, Intra-Cellular is well-positioned to further expand the addressable market for CAPLYTA. The company estimates that the total addressable market for CAPLYTA increases to approximately 80% of the annual antipsychotic market prescriptions with the addition of an MDD indication, up from nearly 50% with the current bipolar and schizophrenia indications.

MDD is a highly prevalent disorder, affecting approximately 21 million adults in the U.S. every year. The company's second Phase 3 trial in MDD, Study 502, has recently completed clinical conduct, and Intra-Cellular expects to report topline results later in the second quarter of 2024. Subject to positive results, the company anticipates filing a supplemental new drug application (sNDA) with the FDA for approval of lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD in the second half of 2024.

Business Overview

Robust Pipeline Supports Long-Term Growth

In addition to the progress with lumateperone, Intra-Cellular continues to advance its robust pipeline of product candidates. The company's lumateperone pediatric program includes an open-label safety study in schizophrenia and bipolar disorder, a double-blind, placebo-controlled study in bipolar depression, and two double-blind, placebo-controlled studies in irritability associated with autism spectrum disorder. Patient enrollment is ongoing in the open-label safety study and the bipolar depression study.

Intra-Cellular is also developing a long-acting injectable (LAI) formulation of lumateperone to provide more treatment options for patients suffering from mental illness. The company has conducted a Phase 1 study with an LAI formulation and is evaluating several additional formulations with treatment durations of one month and longer. Intra-Cellular expects to commence clinical conduct of a Phase 1 study with these new LAI formulations in the second half of 2024.

The company's pipeline also includes ITI-1284-ODT-SL, a deuterated form of lumateperone formulated as an oral disintegrating tablet for sublingual administration. Intra-Cellular has initiated Phase 2 programs evaluating ITI-1284-ODT-SL for the treatment of generalized anxiety disorder, psychosis in Alzheimer's disease, and agitation in patients with Alzheimer's disease.

Furthermore, Intra-Cellular's phosphodiesterase 1 (PDE1) inhibitor program includes lenrispodun (ITI-214), which is currently in a Phase 2 clinical trial for Parkinson's disease. The company also has an active Investigational New Drug application for its newest PDE1 inhibitor candidate, ITI-1020, which is being developed as a novel cancer immunotherapy.

Intra-Cellular's earlier-stage programs include ITI-333, a novel compound being developed as a potential treatment for substance use disorders, pain, and psychiatric comorbidities, and the ITI-1500 program focused on the development of novel non-hallucinogenic psychedelics for mood, anxiety, and other neuropsychiatric disorders.

Solid Commercial Execution and Expanding Prescriber Base

Intra-Cellular's commercial performance has been strong, with CAPLYTA net sales growing 53% year-over-year in the first quarter of 2024. The company's sales force is currently educating a prescriber base of more than 39,000 healthcare providers since launch, and physicians continue to appreciate CAPLYTA's proven efficacy, favorable safety and tolerability profile, and convenient once-daily dosing.

Intra-Cellular's marketing efforts are complemented by a comprehensive program, including extensive peer-to-peer medical education, digital promotion, and a broad national consumer advertising campaign. The company recently launched a new consumer TV advertisement depicting the experience of people living with bipolar depression and the benefits CAPLYTA may provide.

Intra-Cellular also enjoys a strong market access position, with over 99% of lives covered in Medicare and Medicaid and about 90% of lives covered in commercial plans. The company's recent gains in unrestricted status on two of the largest Medicare Part D plans are expected to contribute to CAPLYTA's continued growth throughout 2024.

Conclusion

Intra-Cellular Therapies is well-positioned for continued growth, both in the short term and the long term, as it works to establish CAPLYTA as a first-choice treatment across mood disorders. The company's robust clinical data, including the positive results from the MDD study, coupled with its strong commercial execution and expanding prescriber base, provide a solid foundation for future success. With a healthy balance sheet and a diversified pipeline of promising product candidates, Intra-Cellular is poised to capitalize on the significant opportunities ahead and deliver value for shareholders.