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Intra-Cellular Therapies (ITCI)
NASDAQ:ITCI

Intra-Cellular Therapies (ITCI) AI Stock Analysis

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Intra-Cellular Therapies

(NASDAQ:ITCI)

69Neutral
Intra-Cellular Therapies' overall score reflects a mix of strong growth potential and strategic positioning due to the acquisition by Johnson & Johnson, against the backdrop of operational challenges and a high-risk valuation. The robust technical momentum supports the stock's short-term outlook, but overvaluation concerns and ongoing financial losses present potential risks.
Positive Factors
Financial Performance
Caplyta revenues of $199.2M were slightly above consensus, indicating better-than-expected financial performance.
Regulatory Approval
FDA accepted the sNDA for Caplyta in adjunctive MDD, highlighting progress in regulatory approval.
Negative Factors
Stock Trading
Analyst is downgrading ITCI from Buy to HOLD as the stock is not trading on fundamentals.

Intra-Cellular Therapies (ITCI) vs. S&P 500 (SPY)

Intra-Cellular Therapies Business Overview & Revenue Model

Company DescriptionIntra-Cellular Therapies (ITCI) is a biopharmaceutical company focused on the development and commercialization of innovative treatments for neuropsychiatric and neurodegenerative disorders. The company's lead product, CAPLYTA (lumateperone), is an FDA-approved atypical antipsychotic for the treatment of schizophrenia in adults. ITCI is dedicated to enhancing the lives of patients by advancing a pipeline of novel drugs that target underlying causes in mental health disorders.
How the Company Makes MoneyIntra-Cellular Therapies makes money primarily through the commercialization of its lead product, CAPLYTA, which generates revenue from sales to healthcare providers, hospitals, and pharmacies. The company may also receive milestone payments, royalties, or other forms of income from partnerships and collaborations in the pharmaceutical industry. Additionally, ITCI invests in ongoing research and development to expand its product offerings and address unmet needs in the treatment of mental health disorders, potentially leading to future revenue streams.

Intra-Cellular Therapies Financial Statement Overview

Summary
Intra-Cellular Therapies is experiencing impressive revenue growth, with a substantial increase from $22.53 million in 2020 to $680.85 million in 2024. However, the company remains unprofitable, with negative net income and negative EBIT/EBITDA margins, indicating continued operational challenges. The balance sheet is relatively strong with low debt and robust cash reserves, but negative cash flow from operations suggests reliance on external funding.
Income Statement
65
Positive
Intra-Cellular Therapies has shown strong revenue growth, with a significant increase from $22.53 million in 2020 to $680.85 million in 2024. However, the company remains unprofitable with a negative net income and negative EBIT/EBITDA margins, indicating continued operational challenges.
Balance Sheet
70
Positive
The balance sheet of Intra-Cellular Therapies is relatively strong, with a low debt-to-equity ratio reflecting conservative leverage. Stockholders' equity has improved significantly, and cash reserves are robust, contributing to financial stability.
Cash Flow
55
Neutral
Cash flow from operations remains negative, suggesting ongoing cash burn. Despite this, the company has managed free cash flow through significant financing activities, indicating reliance on external funding to sustain operations.
Breakdown
Dec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
680.85M464.37M249.13M81.71M22.53M
Gross Profit
623.89M430.63M228.69M73.67M20.64M
EBIT
-116.72M-159.38M-263.63M-285.69M-231.23M
EBITDA
-116.72M-158.85M-262.97M-285.15M-230.70M
Net Income Common Stockholders
-74.68M-139.67M-256.26M-284.13M-227.01M
Balance SheetCash, Cash Equivalents and Short-Term Investments
1.00B497.94M591.90M412.33M657.45M
Total Assets
1.37B728.29M754.78M489.92M717.31M
Total Debt
16.98M16.94M20.04M25.41M29.14M
Net Debt
-289.97M-130.83M-128.57M-66.96M-30.90M
Total Liabilities
218.45M136.87M98.71M72.03M60.45M
Stockholders Equity
1.15B591.42M656.07M417.89M656.86M
Cash FlowFree Cash Flow
-73.50M-124.47M-270.96M-259.87M-230.34M
Operating Cash Flow
-73.18M-124.20M-270.19M-259.54M-230.07M
Investing Cash Flow
-335.15M105.54M-128.37M280.34M-480.30M
Financing Cash Flow
567.51M17.81M455.16M11.52M664.18M

Intra-Cellular Therapies Technical Analysis

Technical Analysis Sentiment
Positive
Last Price131.25
Price Trends
50DMA
119.46
Positive
100DMA
101.64
Positive
200DMA
87.54
Positive
Market Momentum
MACD
2.94
Positive
RSI
85.02
Negative
STOCH
96.38
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ITCI, the sentiment is Positive. The current price of 131.25 is above the 20-day moving average (MA) of 129.29, above the 50-day MA of 119.46, and above the 200-day MA of 87.54, indicating a bullish trend. The MACD of 2.94 indicates Positive momentum. The RSI at 85.02 is Negative, neither overbought nor oversold. The STOCH value of 96.38 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for ITCI.

Intra-Cellular Therapies Risk Analysis

Intra-Cellular Therapies disclosed 51 risk factors in its most recent earnings report. Intra-Cellular Therapies reported the most risks in the “Finance & Corporate” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Intra-Cellular Therapies Peers Comparison

Overall Rating
UnderperformOutperform
Sector (49)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
79
Outperform
$2.87B12.6438.89%31.85%
69
Neutral
$13.96B-8.58%46.62%50.50%
69
Neutral
$22.06B13.4810.36%-1.60%39.71%
68
Neutral
$11.05B33.6914.16%24.81%33.67%
64
Neutral
$128.40B-3.15%11.64%-114.72%
49
Neutral
$6.90B-0.08-53.01%2.43%24.84%-3.06%
43
Neutral
$446.97M-63.37%-52.30%27.13%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ITCI
Intra-Cellular Therapies
131.24
66.87
103.88%
ACAD
ACADIA Pharmaceuticals
17.19
-2.79
-13.96%
BIIB
Biogen
143.66
-83.70
-36.81%
NBIX
Neurocrine
107.22
-30.52
-22.16%
VRTX
Vertex Pharmaceuticals
488.34
75.89
18.40%
SAGE
SAGE Therapeutics
7.40
-12.95
-63.64%

Intra-Cellular Therapies Earnings Call Summary

Earnings Call Date: Feb 21, 2025 | % Change Since: 2.11% | Next Earnings Date: May 13, 2025
Earnings Call Sentiment Positive
The earnings call highlighted robust growth in CAPLYTA sales and a strong financial position, supported by strategic investments in sales force expansion and promising pipeline developments. However, increased expenses and ongoing challenges in developing long-acting injectable formulations were noted as potential concerns.
Highlights
Record CAPLYTA Sales Growth
CAPLYTA's net sales reached $175.2 million in Q3 2024, marking a 39% increase over Q3 2023, and a 9% sequential growth from Q2 2024.
Increased Full Year Sales Guidance
The company raised its 2024 full-year net sales guidance range to $665 million to $685 million due to continued strong performance.
Expansion of Sales Force
150 new sales representatives were added to focus on primary care physicians, indicating a strategic investment to sustain CAPLYTA's growth.
Promising Pipeline Developments
The company is advancing multiple Phase II and III programs, including ITI-1284 for GAD and psychosis in Alzheimer's, as well as long-acting injectable formulations.
Strong Financial Position
The company reported $1 billion in cash and investments as of September 30, 2024, indicating a robust financial position to support future growth.
Lowlights
Increased SG&A and R&D Expenses
Selling, general and administrative expenses increased to $132.1 million, and R&D expenses rose to $66.8 million in Q3 2024, reflecting increased spending on sales force expansion and clinical trials.
Challenges in Developing LAI Formulations
The long-acting injectable program for lumateperone is still in early Phase I trials, with multiple formulations being tested, indicating potential delays and uncertainty in development.
Company Guidance
During the third quarter 2024 earnings call for Intra-Cellular Therapies, the company provided updated guidance and highlighted key performance metrics. CAPLYTA's net sales reached $175.2 million, marking a 39% increase compared to the same quarter in 2023. Driven by strong prescription demand, the company raised its full-year 2024 net sales guidance to a range of $665 million to $685 million. CAPLYTA achieved a 38% year-over-year growth in total prescriptions and a 9% sequential quarter-over-quarter growth rate. The company also expanded its sales force by adding 150 new representatives, aiming to enhance outreach in the primary care market. Additionally, Intra-Cellular Therapies positioned CAPLYTA as a potential $5 billion opportunity within the next decade, supported by the drug's robust efficacy and favorable safety profile in mood disorders, including major depressive disorder (MDD) and bipolar depression. The company continues to advance its pipeline, with significant progress in its lumateperone long-acting injectable and ITI-1284 development programs, targeting generalized anxiety disorder and Alzheimer's disease-related conditions.

Intra-Cellular Therapies Corporate Events

M&A TransactionsBusiness Operations and Strategy
Johnson & Johnson to Acquire Intra-Cellular Therapies
Positive
Jan 13, 2025

Johnson & Johnson has entered into an agreement to acquire Intra-Cellular Therapies for approximately $14.6 billion, enhancing its neuroscience portfolio with Intra-Cellular’s CAPLYTA® and promising pipeline. The acquisition positions Johnson & Johnson strategically for growth in the neuropsychiatric and neurodegenerative disorder markets, as CAPLYTA® has the potential to become a standard treatment for major depressive disorder if approved by the FDA.

Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.