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Intra-Cellular Therapies Reports Second Quarter 2024 Financial Results, Provides Corporate Update and Raises 2024 CAPLYTA Sales Guidance

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Intra-Cellular Therapies (ITCI) reported strong Q2 2024 results, with CAPLYTA net product sales reaching $161.3 million, a 46% increase year-over-year. Total prescriptions for CAPLYTA grew 36% compared to Q2 2023. The company raised its 2024 CAPLYTA sales guidance to $650-$680 million.

ITCI announced positive Phase 3 results for lumateperone as an adjunctive therapy for major depressive disorder (MDD), with an sNDA submission planned for H2 2024. The company also initiated patient enrollment in Phase 2 studies for ITI-1284 in generalized anxiety disorder and Alzheimer's-related psychosis.

Despite strong sales growth, ITCI reported a net loss of $16.2 million for Q2 2024, an improvement from the $42.8 million loss in Q2 2023. The company ended the quarter with a strong cash position of $1.025 billion.

Intra-Cellular Therapies (ITCI) ha riportato risultati solidi per il secondo trimestre del 2024, con vendite nette di CAPLYTA pari a 161,3 milioni di dollari, un aumento del 46% rispetto all'anno precedente. Le prescrizioni totali per CAPLYTA sono cresciute del 36% rispetto al secondo trimestre del 2023. L'azienda ha rivisto al rialzo le stime di vendita per CAPLYTA nel 2024 a 650-680 milioni di dollari.

ITCI ha annunciato risultati positivi nella Fase 3 per lumateperone come terapia aggiuntiva per il disturbo depressivo maggiore (MDD), con una sNDA prevista per il secondo semestre del 2024. L'azienda ha anche avviato l'arruolamento di pazienti negli studi di Fase 2 per ITI-1284 nel disturbo d'ansia generalizzata e nella psicosi correlata all'Alzheimer.

Nonostante la forte crescita delle vendite, ITCI ha riportato una perdita netta di 16,2 milioni di dollari per il secondo trimestre del 2024, un miglioramento rispetto alla perdita di 42,8 milioni di dollari nel secondo trimestre del 2023. L'azienda ha chiuso il trimestre con una solida posizione di cassa di 1,025 miliardi di dollari.

Intra-Cellular Therapies (ITCI) reportó resultados sólidos para el segundo trimestre de 2024, con ventas netas del producto CAPLYTA alcanzando $161.3 millones, un aumento del 46% en comparación con el año anterior. Las recetas totales para CAPLYTA crecieron un 36% en comparación con el segundo trimestre de 2023. La compañía aumentó su guía de ventas de CAPLYTA para 2024 a $650-$680 millones.

ITCI anunció resultados positivos de la Fase 3 para lumateperona como terapia adjunta para el trastorno depresivo mayor (MDD), con una presentación de sNDA planeada para la segunda mitad de 2024. La compañía también inició el reclutamiento de pacientes en estudios de Fase 2 para ITI-1284 en trastorno de ansiedad generalizada y psicosis relacionada con el Alzheimer.

A pesar del fuerte crecimiento en ventas, ITCI reportó una pérdida neta de $16.2 millones para el segundo trimestre de 2024, una mejora en comparación con la pérdida de $42.8 millones en el segundo trimestre de 2023. La empresa terminó el trimestre con una sólida posición de efectivo de $1.025 mil millones.

인트라 셀룰러 테라피스 (ITCI)는 2024년 2분기에 CAPLYTA의 순매출이 1억 6,130만 달러에 달했다고 보고했으며, 이는 전년 대비 46% 증가한 수치입니다. CAPLYTA의 총 처방 건수는 2023년 2분기 대비 36% 증가했습니다. 회사는 2024년 CAPLYTA 판매 전망을 6억 5천만 달러에서 6억 8천만 달러로 상향 조정했다고 발표했습니다.

ITCI는 주요 우울증 장애(MDD)에 대한 보조 요법으로서 루마테페론의 3상 긍정적 결과를 발표했으며, 2024년 하반기에 sNDA 제출이 예정되어 있습니다. 또한, ITCI-1284에 대한 2상 연구에 대한 환자 등록을 시작했습니다. 이는 일반화된 불안 장애 및 알츠하이머 관련 정신병 대상입니다.

강력한 판매 성장에도 불구하고, ITCI는 2024년 2분기에 1천620만 달러의 순손실을 보고했으며, 이는 2023년 2분기 4천280만 달러 손실보다 개선된 수치입니다. 회사는 10억 2천500만 달러의 강력한 현금 자산으로 분기를 마감했습니다.

Intra-Cellular Therapies (ITCI) a annoncé de solides résultats pour le deuxième trimestre 2024, avec des ventes nettes de CAPLYTA atteignant 161,3 millions de dollars, soit une augmentation de 46 % par rapport à l'année précédente. Les prescriptions totales pour CAPLYTA ont augmenté de 36 % par rapport au deuxième trimestre 2023. L'entreprise a relevé ses prévisions de ventes pour CAPLYTA à 650-680 millions de dollars pour 2024.

ITCI a annoncé des résultats positifs de la phase 3 pour la lumatepérone en tant que thérapie adjuvante pour le trouble dépressif majeur (MDD), avec une soumission de sNDA prévue pour le second semestre 2024. L'entreprise a également lancé le recrutement de patients dans des études de phase 2 pour l'ITI-1284 dans le cadre du trouble anxieux généralisé et de la psychose liée à la maladie d'Alzheimer.

Malgré une forte croissance des ventes, ITCI a annoncé une perte nette de 16,2 millions de dollars pour le deuxième trimestre 2024, une amélioration par rapport à la perte de 42,8 millions de dollars pour le même trimestre en 2023. L'entreprise a terminé le trimestre avec une solide position de trésorerie de 1,025 milliard de dollars.

Intra-Cellular Therapies (ITCI) berichtete solide Ergebnisse für das zweite Quartal 2024, wobei die Nettoproduktverkäufe von CAPLYTA 161,3 Millionen Dollar erreichten, was einem Anstieg von 46 % im Vergleich zum Vorjahr entspricht. Die Gesamtverschreibungen für CAPLYTA stiegen im Vergleich zum zweiten Quartal 2023 um 36 %. Das Unternehmen erhöhte seine Verkaufsprognose für CAPLYTA für 2024 auf 650-680 Millionen Dollar.

ITCI gab positive Ergebnisse der Phase 3 für Lumateperon als ergänzende Therapie bei majorer Depression (MDD) bekannt, mit einer geplanten sNDA-Einreichung für das zweite Halbjahr 2024. Das Unternehmen begann auch mit der Patienteneinschreibung in Phase-2-Studien für ITI-1284 bei generalisierter Angststörung und Alzheimer-assoziierter Psychose.

Trotz des starken Umsatzwachstums meldete ITCI einen Nettoverlust von 16,2 Millionen Dollar für das zweite Quartal 2024, eine Verbesserung gegenüber dem Verlust von 42,8 Millionen Dollar im zweiten Quartal 2023. Das Unternehmen schloss das Quartal mit einer soliden Bargeldposition von 1,025 Milliarden Dollar ab.

Positive
  • CAPLYTA Q2 2024 net product sales increased 46% year-over-year to $161.3 million
  • Total prescriptions for CAPLYTA grew 36% compared to Q2 2023
  • 2024 CAPLYTA sales guidance raised to $650-$680 million
  • Positive Phase 3 results for lumateperone in MDD, with sNDA submission planned for H2 2024
  • Strong cash position of $1.025 billion as of June 30, 2024
  • Net loss decreased from $42.8 million in Q2 2023 to $16.2 million in Q2 2024
Negative
  • SG&A expenses increased to $121.6 million in Q2 2024 from $101.0 million in Q2 2023
  • R&D expenses rose to $56.2 million in Q2 2024 from $49.8 million in Q2 2023
  • Company still operating at a net loss despite strong sales growth

Insights

Intra-Cellular Therapies' Q2 2024 results show strong growth for CAPLYTA, with net product sales of $161.3 million, a 46% increase year-over-year. This robust performance led to an increased 2024 sales guidance of $650-$680 million, signaling confidence in continued growth.

The company's financial position remains solid with $1.025 billion in cash and investments. However, despite revenue growth, ITCI still reported a net loss of $16.2 million, albeit significantly reduced from the previous year. The planned sales force expansion may pressure margins in the short term but could drive future growth.

Investors should note the positive Phase 3 results for lumateperone in MDD, which could potentially expand CAPLYTA's market. The upcoming sNDA submission in H2 2024 is a key catalyst to watch.

The positive Phase 3 results for lumateperone as an adjunctive therapy in MDD are highly significant. Both Studies 501 and 502 demonstrated statistically significant and clinically meaningful improvements in MADRS scores, with impressive p-values (<0.0001) and Cohen's d effect sizes (0.61 and 0.56).

Importantly, lumateperone showed a favorable safety profile, with metabolic parameters and weight changes similar to placebo. This differentiates it from many existing antipsychotics and could be a major advantage in the competitive MDD market.

The diverse pipeline, including programs in bipolar mania, pediatric indications and novel compounds like ITI-1284 and PDE1 inhibitors, provides multiple growth opportunities. The advancement of ITI-1549, a non-hallucinogenic neuroplastogen, into human testing in 2025 is particularly intriguing for its potential in mood and anxiety disorders.

CAPLYTA's strong prescription growth of 36% year-over-year indicates significant market penetration and physician adoption. The planned sales force expansion, adding 150 representatives, should further accelerate this trend, especially in the primary care segment.

The potential label expansion into MDD represents a substantial market opportunity. With positive Phase 3 results and an sNDA submission planned for H2 2024, CAPLYTA could enter a large and growing market, competing with established antidepressants.

Intra-Cellular's qualification for the Specified Small Manufacturer Exception under the Inflation Reduction Act is a positive development, potentially shielding the company from certain pricing pressures in the Medicare market. This could provide a competitive advantage and help maintain strong pricing power for CAPLYTA.

CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase

CAPLYTA’s strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023

CAPLYTA 2024 net product sales guidance raised to $650 to $680 million

Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disorder (MDD)

Supplemental NDA (sNDA) submission for lumateperone as an adjunctive therapy to antidepressants in patients with MDD anticipated in the second half of 2024

Commenced patient enrollment in ITI-1284 Phase 2 Studies in Generalized Anxiety Disorder and Psychosis associated with Alzheimer’s disease

NEW YORK, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the second quarter ended June 30, 2024 and provided a corporate update.

“We are very pleased with the strong performance of CAPLYTA during the second quarter and look forward to continued growth for the remainder of 2024,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “Our team is also focused on preparing our sNDA for MDD for submission later this year and continues to advance our robust pipeline.”

Second Quarter Financial Highlights:

  • Total revenues were $161.4 million for the second quarter of 2024, compared to $110.8 million for the same period in 2023. Net product sales of CAPLYTA were $161.3 million for the second quarter of 2024, compared to $110.1 million for the same period in 2023.
  • Net loss for the second quarter of 2024 was $16.2 million compared to a net loss of $42.8 million for the same period in 2023.
  • Cost of product sales was $11.4 million in the second quarter of 2024 compared to $7.2 million for the same period in 2023.
  • Selling, general and administrative (SG&A) expenses were $121.6 million for the second quarter of 2024, compared to $101.0 million for the same period in 2023.
  • Research and development (R&D) expenses were $56.2 million for the second quarter of 2024, compared to $49.8 million for the same period in 2023.
  • Cash, cash equivalents, investment securities, and restricted cash totaled $1.025 billion at June 30, 2024.

Commercial Update

  • CAPLYTA total prescriptions increased 36% in the second quarter of 2024, compared to the same period in 2023 and 10% in the second quarter of 2024, compared to the first quarter of 2024.
  • To fully leverage the growing opportunity with primary care physicians in our current CAPLYTA indications, we plan to increase the size of our sales force during the third quarter of this year to expand our reach and frequency in primary care offices. In connection with this expansion, we are adding approximately 150 sales representatives. We expect to complete a second sales force expansion in 2025 in connection with the potential approval of CAPLYTA for the adjunctive treatment of MDD.
  • Received notification from the Centers for Medicare and Medicaid Services that CAPLYTA qualified for the Specified Small Manufacturer Exception pertaining to the Part D redesign of the Inflation Reduction Act.

Fiscal 2024 Financial Outlook:

  • CAPLYTA full year 2024 net product sales guidance range raised to $650 to $680 million.
  • Full year 2024 SG&A expense guidance range increased to $480 t$510 million. This increase is primarily the result of sales, marketing and other expenses associated with the sales force expansion in the primary care segment in the second half of 2024.
  • Full year 2024 R&D expense guidance range lowered to $210 t$230 million.

CLINICAL HIGHLIGHTS

Lumateperone:

  • Adjunctive MDD program: Studies 501 and 502 are our global Phase 3 pivotal clinical trials evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. Following the positive and robust results in Study 501 in April 2024 and in Study 502 in June 2024, we anticipate submitting an sNDA with the U.S. Food and Drug Administration (FDA) in the second half of 2024.

    In these studies, lumateperone robustly met the primary endpoint by demonstrating reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score compared to placebo plus antidepressants at Week 6. Results for the primary endpoint are summarized as follows:
Primary Endpoint: Change from baseline vs. placebo on the MADRS Total Score at Week 6 (modified intent-to-treat study population)
  Least Squares (LS) Mean Reduction vs. Baseline1LS mean difference1p valueCohen's d effect size
STUDY 501Lumateperone 42 mg +ADT14.7-4.9<0.00010.61
 placebo +ADT9.8   
      
STUDY 502Lumateperone 42 mg+ADT14.7-4.5<0.00010.56
 placebo +ADT10.2   
1 rounded to nearest tenth; ADT: Antidepressant therapy
     

Similarly, in both pivotal studies, lumateperone met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the Clinical Global Impression Scale for Severity of Illness (CGI-S). Statistically significant efficacy was also seen in both studies in the patient reported Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) scale, a self-reported measure of symptom severity of depression.

Lumateperone was generally safe and well-tolerated in these studies and adverse events were similar to those seen in prior studies of lumateperone in bipolar depression, MDD with mixed features, and schizophrenia. In Study 501 and Study 502, mean changes in key metabolic parameters, including glucose, insulin, triglycerides, and total, LDL and HDL cholesterol, were similar between lumateperone and placebo. Importantly, mean changes in weight were also similar to placebo.

  • Lumateperone bipolar mania program: In the second quarter of 2024, we initiated two multicenter, randomized, double-blind, placebo-controlled, Phase 3 studies evaluating lumateperone in the acute treatment of manic or mixed episodes associated with bipolar I disorder (bipolar mania).
  • Lumateperone pediatric program: We expect to begin patient enrollment in two studies in pediatric patients for the treatment of irritability associated with autism spectrum disorder in the second half of 2024. In addition, patient enrollment is ongoing in our double-blind, placebo-controlled study in bipolar depression and in our open-label safety study in schizophrenia and bipolar disorder in pediatric patients.
  • Lumateperone Long Acting Injectable (LAI) program: We expect to commence clinical conduct in a Phase 1 single ascending dose study with several formulations shortly. The goal of the program is to develop LAI formulations that are effective, safe, and well-tolerated with treatment durations of one month or longer.

Other pipeline programs:

  • ITI-1284-ODT-SL program: We have initiated patient enrollment in our Phase 2 clinical study evaluating ITI-1284 as adjunctive therapy to anti-anxiety medications in patients with generalized anxiety disorder (GAD). We expect to initiate a second Phase 2 GAD study, evaluating ITI-1284 as monotherapy, later this year. We have also initiated patient enrollment in a Phase 2 clinical study evaluating ITI-1284 as monotherapy in patients with psychosis associated with Alzheimer’s disease. We anticipate commencing patient enrollment in our Phase 2 program in agitation associated with Alzheimer’s disease shortly.
  • Phosphodiesterase type I inhibitor (PDE1) program: Our portfolio of PDE1 inhibitors continues to advance in clinical development.

    Lenrispodun (ITI-214) Parkinson’s disease (PD) program: Our Phase 2 clinical trial is ongoing with topline results anticipated in 2025. The objective of this study is to evaluate improvements in motor symptoms in patients with PD. Changes in cognition and inflammatory biomarkers are also being assessed.

    ITI-1020 cancer immunotherapy program: Our Phase 1 single ascending dose study in healthy volunteers is ongoing. The objective of this study is to evaluate pharmacokinetics, safety, and tolerability of different doses of ITI-1020.
  • ITI-333 program: ITI-333, a 5-HT2A receptor antagonist and μ-opioid receptor partial agonist, provides potential utility in the treatment of opioid use disorder and pain. A multiple ascending dose study and a positron emission tomography (PET) study are both ongoing.
  • ITI-1500 Non-Hallucinogenic Neuroplastogen Program: This program, previously referred to as our non-hallucinogenic psychedelic program, is focused on the development of novel neuroplastogens for the treatment of mood, anxiety, and other neuropsychiatric disorders without the hallucinogenic and cardiovascular effects of psychedelics. Our lead product candidate in this program, ITI-1549, continues to advance through IND enabling studies and is expected to enter human testing in 2025.

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. To attend the live conference call by phone, please use this registration link (https://register.vevent.com/register/BIa69e7f7949b74f8d9bc7846c268b0ecd). All participants must use the link to complete the online registration process in advance of the conference call. The live and archived webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

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 antidepressant-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 or moderate CYP3A4 inhibitors.

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. Dose reduction is recommended for patients with moderate or severe hepatic impairment.

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.

CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

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 the treatment of 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 psychiatric and neurological disorders. Lumateperone is not FDA-approved for these disorders.

About Intra-Cellular Therapies

Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

Forward-Looking Statements

This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our financial and operating performance, including our future revenues and expenses; our expectations regarding the commercialization of CAPLYTA; our plans to expand our sales force; our plans to conduct clinical or non-clinical trials and the timing of developments with respect to those trials, including enrollment, initiation or completion of clinical conduct, or the availability or reporting of results; plans to make regulatory submissions to the FDA and the timing of such submissions; whether clinical trial results will be predictive of future real-world results; whether CAPLYTA will serve an unmet need; the goals of our development programs; our beliefs about the potential utility of our product candidates; and development efforts and plans under the caption “About Intra-Cellular Therapies.” All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the following: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indications; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia and bipolar depression following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; challenges associated with supply and manufacturing activities, which in each case could limit our sales and the availability of our product; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or bipolar depression or in ongoing or future trials and other development activities; there is no guarantee that a generic equivalent of CAPLYTA will not be approved and enter the market before the expiration of our patents; our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials or in clinical trials for other indications; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; impacts on our business, including on the commercialization of CAPLYTA and our clinical trials, as a result of the COVID-19 pandemic, the conflicts in Ukraine, Russia and the Middle East, global economic uncertainty, inflation, higher interest rates or market disruptions; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.

Contact:

Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333

Burns McClellan, Inc.
Cameron Radinovic
cradinovic@burnsmc.com
212-213-0006


INTRA-CELLULAR THERAPIES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except share and per share amounts) (Unaudited) (1)
 
 Three Months Ended June 30, Six Months Ended June 30,
  2024   2023   2024   2023 
Revenues       
Product sales, net$161,276  $110,128  $306,119  $204,859 
Grant revenue 112   664   135   1,239 
Total revenues, net 161,388   110,792   306,254   206,098 
Operating expenses:       
Cost of product sales 11,354   7,163   21,254   13,914 
Selling, general and administrative 121,574   101,014   234,659   199,937 
Research and development 56,183   49,794   99,016   87,818 
Total operating expenses 189,111   157,971   354,929   301,669 
Loss from operations (27,723)  (47,179)  (48,675)  (95,571)
Interest income 11,560   4,530   17,624   8,879 
Loss before provision for income taxes (16,163)  (42,649)  (31,051)  (86,692)
Income tax expense (57)  (135)  (416)  (145)
Net loss$(16,220) $(42,784) $(31,467) $(86,837)
Net loss per common share:       
Basic & Diluted$(0.16) $(0.45) $(0.31) $(0.91)
Weighted average number of common shares:       
Basic & Diluted 103,723,007   95,948,063   100,299,141   95,543,626 

(1) The condensed consolidated statements of operations for the three and six months ended June 30, 2024 and 2023 have been derived from the financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

INTRA-CELLULAR THERAPIES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands except share and per share amounts) (Unaudited)(1)
 
 June 30,
2024
 December 31,
2023
 (unaudited)  
Assets   
Current assets:   
Cash and cash equivalents$693,306  $147,767 
Investment securities, available-for-sale 329,601   350,174 
Restricted cash 1,750   1,750 
Accounts receivable, net 145,714   114,018 
Inventory 20,082   11,647 
Prepaid expenses and other current assets 73,798   42,443 
Total current assets 1,264,251   667,799 
Property and equipment, net 1,445   1,654 
Right of use assets, net 14,507   12,928 
Inventory, non-current 32,562   38,621 
Other assets 7,739   7,293 
Total assets$1,320,504  $728,295 
Liabilities and stockholders’ equity   
Current liabilities:   
Accounts payable$17,548  $11,452 
Accrued and other current liabilities 39,713   27,944 
Accrued customer programs 77,971   53,173 
Accrued employee benefits 22,372   27,364 
Operating lease liabilities 4,171   3,612 
Total current liabilities 161,775   123,545 
Operating lease liabilities, non-current 14,117   13,326 
Total liabilities 175,892   136,871 
Stockholders’ equity:   
Common stock 11   10 
Additional paid-in capital 2,793,896   2,208,470 
Accumulated deficit (1,648,627)  (1,617,160)
Accumulated comprehensive (loss) income (668)  104 
Total stockholders’ equity 1,144,612   591,424 
Total liabilities and stockholders’ equity$1,320,504  $728,295 

(1) The condensed consolidated balance sheets at June 30, 2024 and December 31, 2023 have been derived from the financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.


FAQ

What were CAPLYTA's Q2 2024 net product sales for ITCI?

CAPLYTA's Q2 2024 net product sales were $161.3 million, representing a 46% increase compared to the same period in 2023.

How much did ITCI raise its 2024 CAPLYTA sales guidance?

ITCI raised its 2024 CAPLYTA sales guidance to $650 to $680 million.

When does ITCI plan to submit the sNDA for lumateperone in MDD?

ITCI anticipates submitting the sNDA for lumateperone as an adjunctive therapy for MDD in the second half of 2024.

What was ITCI's net loss for Q2 2024?

ITCI reported a net loss of $16.2 million for Q2 2024, compared to a net loss of $42.8 million for the same period in 2023.

How much cash and investments did ITCI have as of June 30, 2024?

ITCI reported cash, cash equivalents, investment securities, and restricted cash totaling $1.025 billion as of June 30, 2024.

Intra-Cellular Therapies Inc.

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9.43B
106.02M
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2.28%
Drug Manufacturers - Specialty & Generic
Pharmaceutical Preparations
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