Intra-Cellular Therapies (ITCI) reported fourth-quarter 2024 loss of 16 cents per share, wider than the Zacks Consensus Estimate of a loss of 5 cents. The company had incurred a loss of 29 cents per share in the year-ago quarter.Find the latest EPS estimates and surprises on Zacks Earnings Calendar.Total revenues, comprising only net product sales, came in at $199.2 million, up 51% year over year on the back of strong prescription uptake. The top line beat the Zacks Consensus Estimate of $193 million.ITCI’s ...

Intra-Cellular Therapies (ITCI) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.05. This compares to loss of $0.30 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -220%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.18 per share when it actually produced a loss of $0.25, delivering a surprise of -38.89%.Over the last four quarter ...

Acquisition and Merger - Johnson & Johnson has agreed to acquire the company for $132 per share, totaling approximately $14.6 billion, with the transaction expected to close in 2025[18]. - The company is currently in a pending transaction with Johnson & Johnson, which could adversely affect its business and market price of common stock if not completed as anticipated[129]. - The pending merger with Johnson & Johnson may not be completed within the anticipated timeframe, which could adversely affect the company's business and stock price[132]. - Each share of the company's common stock will be converted into $132.00 in cash upon the effective time of the merger[133]. - The company may incur a termination fee of $475.5 million if the merger agreement is terminated under specific circumstances[135]. - The company is subject to restrictions on business activities while the merger agreement is in effect, which may hinder its ability to pursue strategic opportunities[138]. - The uncertainty surrounding the merger could adversely affect the company's relationships with collaborators, customers, and employees[136]. - The company has incurred significant costs related to the pending merger, which will continue regardless of whether the merger is completed[143]. Drug Development and Approval - CAPLYTA (lumateperone) was approved by the FDA for schizophrenia treatment in adults at a dosage of 42 mg/day in December 2019 and for bipolar depression in December 2021[19]. - The company submitted a supplemental new drug application to the FDA for lumateperone as adjunctive therapy for major depressive disorder, which was accepted for review in Q1 2025[26]. - The FDA accepted the supplemental New Drug Application (sNDA) for lumateperone for the treatment of Major Depressive Disorder (MDD) in adults in Q1 2025, but approval is not guaranteed[154]. - The approval of a new drug requires successful completion of non-clinical tests, submission of an IND, and satisfactory completion of human clinical trials[77]. - The FDA may issue a Complete Response Letter if the NDA submission is deficient, requiring additional data or trials before approval[86]. - The FDA has indicated that the deuterated and undeuterated forms of lumateperone are not identical, necessitating additional toxicology studies for ITI-1284-ODT-SL[36]. - The FDA approval process for drug candidates can take many years, with a standard review goal of 10 months and a priority review goal of 6 months from the filing date of the NDA[84]. - The FDA may require additional clinical trials post-approval, known as Phase 4 trials, to further assess the drug's safety and efficacy[80]. - The company is conducting a global Phase 3 trial (Study 505) to evaluate lumateperone 42 mg in patients with inadequate response to multiple antidepressants[27]. - The company is developing a long-acting injectable formulation of lumateperone, with ongoing Phase 1 studies showing it to be generally safe and well-tolerated[33]. Market and Competition - CAPLYTA competes with established drugs such as Vraylar, Rexulti, and others in the CNS therapeutic area, facing significant competition from both branded and generic products[73]. - The company faces intense competition for skilled personnel, which could delay drug development and commercialization efforts[188]. - Market acceptance of CAPLYTA and other product candidates will depend on evidence of safety and efficacy, pricing, and the effectiveness of marketing strategies[185]. - The company must continue to expand its sales and marketing capabilities to successfully commercialize CAPLYTA and any future product candidates[150]. - The company has limited experience in marketing and distributing pharmaceutical products, relying on third-party distributors for CAPLYTA[200]. Financial Performance and Projections - The company has an accumulated deficit of approximately $1.7 billion as of December 31, 2024, and expects to continue incurring net losses as it advances its programs[155]. - The company generated revenues from product sales but cannot guarantee profitability from CAPLYTA, which is currently approved for schizophrenia and bipolar depression[152]. - The company expects net losses to continue and is unable to predict the extent of future losses or when it will become profitable[129]. - The company had $1.0 billion in cash, cash equivalents, investment securities, and restricted cash as of December 31, 2024, indicating a need for additional funding to support ongoing operations[156]. Regulatory Compliance and Risks - Companies must comply with extensive regulatory requirements, including maintaining cGMP compliance and conducting pharmacovigilance programs after drug approval[88]. - Regulatory compliance is critical, as failure to meet requirements could delay or prevent the commercialization of products[182]. - The company is subject to significant risks related to compliance with federal and state health care fraud and abuse laws, which could result in substantial penalties[106]. - The company faces ongoing regulatory obligations and restrictions regarding CAPLYTA, which may limit its ability to commercialize the product effectively[146]. - The company is exposed to risks related to pricing pressures from third-party payers and potential legislative changes affecting drug pricing and reimbursement[197]. Intellectual Property - The company owns or controls approximately 142 patent families and 158 issued U.S. patents as of February 1, 2025, supporting its drug development efforts[57]. - The Lumateperone program includes approximately 38 patent families, with 65 issued U.S. patents and 193 issued foreign patents[58]. - ITI-1284 has composition of matter protection until 2037, with possible extensions to 2042[59]. - ITI-1500 program provides composition of matter patent protection through at least 2043, with potential extensions to 2048[60]. - Lenrispodun has composition of matter protection until 2029, with possible extensions to 2034 and expected data exclusivity in the EU for up to 11 years from commercial launch[61]. - The company intends to apply for patent term restorations for certain patents to extend their life beyond current expiration dates[92]. Workforce and Organizational Structure - As of February 1, 2025, the company employed 860 full-time employees and expanded its sales force by approximately 150 representatives in 2024 to focus on CAPLYTA sales[107]. - The company recognizes the importance of diversity and inclusion in its workforce, believing it enhances business performance[109]. - The company has outsourced substantial clinical trial work and drug manufacturing to contract manufacturers, balancing in-house expertise with outsourced capacity[107]. Sustainability and Corporate Responsibility - The company has implemented a Sustainability Working Group responsible for preparing its annual Sustainability report, overseen by the Board of Directors[115]. - The company has taken steps to enhance the sustainability of its manufacturing processes and supply chain to reduce environmental impact[119]. Cybersecurity - Cybersecurity incidents pose risks that could compromise sensitive information and disrupt business operations[212]. - The company relies on third-party information technology systems, which increases vulnerability to cybersecurity threats[212]. - Cyber-attacks are becoming more frequent and sophisticated, potentially impacting the company's supply chain and operational integrity[217].

Exhibit 99.1 INTRA-CELLULAR THERAPIES REPORTS FOURTH QUARTER AND FULL-YEAR 2024 FINANCIAL RESULTS Fourth quarter 2024 CAPLYTA net product sales grew to $199.2 million, representing a 51% increase over the same period in 2023 Full year 2024 CAPLYTA net product sales were $680.5 million, representing year-over-year growth of 47% The U.S. Food and Drug Administration (FDA) accepted for review the lumateperone supplemental New Drug Application (sNDA) submission for adjunctive treatment of major depressive disor ...

Acquisition Details - Johnson & Johnson (JNJ) will acquire all outstanding shares of Intra-Cellular Therapies (ITCI) for $132 per share in cash, totaling approximately $14.6 billion [1] - The transaction is expected to be completed later this year, subject to customary closing conditions and regulatory approvals [3] ITCI's Marketed Drug and Pipeline - ITCI's sole marketed drug, Caplyta, is approved for schizophrenia and bipolar depression, with a regulatory filing submitted to the FDA for label expansion in major depressive disorder (MDD) [2] - ITCI is developing ITI-1284 for generalized anxiety disorder, Alzheimer's disease-related psychosis, and agitation, which will be added to J&J's pipeline post-acquisition [3] Stock Performance and Market Impact - Following the acquisition announcement, ITCI's stock rallied 34% on Monday, with a 92% increase over the past year compared to the industry's 16% decline [4] - Caplyta's sales grew 46% year-over-year to $481 million in the first nine months of 2024, with potential for further growth under J&J's commercial expertise [5] Strategic Fit for J&J - The acquisition aligns with J&J's neuroscience franchise, which includes drugs like Invega Sustenna and Spravato, and complements its late-stage investigational drug aticaprant for MDD [4] - A potential approval for Caplyta in the MDD indication could provide J&J with a blockbuster drug and be immediately accretive to its earnings [5] Financial Impact and Guidance - J&J plans to provide the financial impact of the transaction on its adjusted EPS during the Q4 earnings call on January 22, 2025 [6] Patent Litigation Victory - ITCI recently secured a patent litigation victory, protecting Caplyta from generic competition until at least July 1, 2040, under a settlement agreement with Sandoz [7]

Intra-Cellular Therapies (ITCI) shares rallied 34.1% in the last trading session to close at $127.19. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 14.3% gain over the past four weeks.The surge in stock price came after pharma giant J&J announced its intent to acquire all outstanding shares of ITCI for $132 per share in cash, aggregating to nearly $14.6 billion. The deal is expected to be completed before t ...

CytomX Therapeutics (CTMX) - Estimates for 2024 loss per share have remained constant at 5 cents [1] - Estimates for 2025 loss per share have remained constant at 35 cents [1] - The stock has lost 19 3% in the past three months [1] - Earnings beat estimates in two of the trailing four quarters with an average surprise of 115 70% [1] Intra-Cellular Therapies (ITCI) - Shares rallied 14 9% after announcing a settlement agreement with Sandoz regarding Caplyta patent litigation [2] - The settlement resolves patent litigation related to Sandoz's attempt to market a generic version of Caplyta before patent expiration [3] - Caplyta is approved for treating schizophrenia and bipolar depression in adults and is the only approved treatment for bipolar depression [4] - The FDA approved new dosage strengths of Caplyta in 2022 for patients taking CYP3A4 inhibitors or with hepatic impairment [5] - Shares have gained 28 5% in the past three months against the industry's 12 7% decline [5] - The stock gained 35% in pre-market hours after Johnson & Johnson announced a definitive agreement to acquire ITCI for approximately $14 6 billion [5] - Sandoz can start selling generic versions of Caplyta on July 1 2040 or earlier under specific conditions [6] - Similar patent litigation against other parties is still ongoing [8] - Caplyta is ITCI's only marketed product and generated $481 3 million in net product sales in the first nine months of 2024 a 46% increase year-over-year [9] - Sandoz was spun off from Novartis in 2023 and is now an independent company [10] Castle Biosciences (CSTL) - 2024 earnings per share estimates have remained constant at 34 cents [12] - 2025 loss per share estimates have remained constant at $1 84 [12] - Shares have lost 11 7% in the past three months [12] - Earnings beat estimates in each of the trailing four quarters with an average surprise of 172 72% [12]

Core Insights - Johnson & Johnson (JNJ) is acquiring Intra-Cellular Therapies (ITCI) for approximately $14.6 billion, leading to a 35% surge in ITCI's shares during premarket trading [1] - The acquisition price is set at $132 per share, representing a 40% premium over ITCI's closing price at the end of the previous week [2] - Intra-Cellular's Caplyta, which treats schizophrenia and bipolar I and II depression, has recently settled a patent lawsuit, contributing to a 15% increase in its share price prior to the acquisition announcement [2] - Intra-Cellular has additional drugs in development targeting Alzheimer's Disease and Parkinson's Disease, enhancing its portfolio value [3] - The deal is expected to close later this year, pending regulatory and shareholder approvals, with JNJ financing the acquisition through cash and debt [4] - JNJ plans to provide insights on the potential impact of the acquisition on adjusted earnings per share during its fourth-quarter earnings call on January 22 [4] - Following the announcement, Intra-Cellular shares reached a record high of $127.90, while JNJ's shares remained stable at $142.49 [5]

Company Overview - Intra-Cellular Therapies (ITCI) shares increased by 14.9% to close at $94.87, with trading volume significantly higher than usual, contrasting with a 1% loss over the past four weeks [1] - The stock price surge followed the announcement of a settlement agreement with Sandoz regarding the Caplyta (lumateperone) patent litigation, allowing Sandoz to sell generic versions of Caplyta starting July 1, 2040, or earlier under specific conditions [2] - A Bloomberg article suggesting that Johnson & Johnson is in talks to acquire ITCI for $10 billion may have also contributed to the stock price rally [2] Financial Performance - ITCI is expected to report a quarterly loss of $0.05 per share, reflecting an 83.3% year-over-year change, with revenues projected at $192.86 million, a 46% increase from the previous year [3] - The consensus EPS estimate for ITCI has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - ITCI operates within the Zacks Medical - Biomedical and Genetics industry, where Cartesian Therapeutics, Inc. (RNAC) has also been noted, finishing the last trading session down 0.5% at $16.84, with a -15.9% return over the past month [4] - Cartesian Therapeutics' consensus EPS estimate for the upcoming report is -$0.78, representing a 67.5% year-over-year change, and it also holds a Zacks Rank of 3 (Hold) [5]

Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, CAPLYTA® has potential to become a standard of care for most common depressive disorders CAPLYTA® adds to Johnson & Johnson's robust lineup of therapies with $5 billion+ potential in pe ...