Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________ FORM 10-Q _______________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_________to_________ Commission File Number: 001-36274 _______________________ INTRA-CELLULAR ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36274 Intra-Cellular Therapies, Inc. (Exact name of registrant as specified in its charter) Delaware 36-4742850 (S ...

or Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36274 INTRA-CELLULAR THERAPIES, INC. (Exact name of registrant as specified in its charter) Delaware 36-474285 ...

PART I: FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited condensed consolidated financial statements for the quarter ended March 31, 2022, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with accompanying notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a significant increase in total assets to **$868.6 million** as of March 31, 2022, from **$489.9 million** at year-end 2021, primarily driven by a substantial rise in cash, cash equivalents, and investment securities from a public stock offering in January 2022, while total liabilities remained relatively stable and stockholders' equity increased significantly from **$417.9 million** to **$792.8 million** | Account | March 31, 2022 ($ thousands) | December 31, 2021 ($ thousands) | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | 129,295 | 92,365 | | Investment securities, available-for-sale | 642,553 | 319,968 | | **Total Assets** | **868,580** | **489,922** | | **Current Liabilities** | 59,074 | 53,357 | | **Total Liabilities** | **75,830** | **72,032** | | **Total Stockholders' Equity** | **792,750** | **417,890** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the first quarter of 2022, the company reported a significant increase in net product sales to **$34.8 million**, more than double the **$15.6 million** from the same period in 2021, though operating expenses also rose substantially, with R&D costs increasing to **$29.0 million** and SG&A expenses growing to **$75.5 million**, resulting in a higher net loss of **$72.1 million**, or (**$0.78**) per share, compared to a net loss of **$52.7 million**, or (**$0.65**) per share, in Q1 2021 | Account | Three Months Ended March 31, 2022 ($ thousands) | Three Months Ended March 31, 2021 ($ thousands) | | :--- | :--- | :--- | | Product sales, net | 34,755 | 15,579 | | **Total revenues** | **34,996** | **15,878** | | Research and development | 29,043 | 15,058 | | Selling, general and administrative | 75,460 | 52,584 | | **Total operating expenses** | **107,658** | **69,097** | | Loss from operations | (72,662) | (53,219) | | **Net loss** | **(72,119)** | **(52,740)** | | **Net loss per common share** | **(0.78)** | **(0.65)** | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$82.8 million** in Q1 2022 from **$47.8 million** in Q1 2021, reflecting higher operating losses, while investing activities used **$322.0 million** primarily for purchasing investment securities, and financing activities provided **$441.8 million** in cash, almost entirely from the net proceeds of a public stock offering in January 2022, resulting in a net increase in cash, cash equivalents, and restricted cash of **$36.9 million** for the quarter | Cash Flow Activity | Three Months Ended March 31, 2022 ($ thousands) | Three Months Ended March 31, 2021 ($ thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (82,849) | (47,767) | | Net cash provided by (used in) investing activities | (322,035) | 116,269 | | Net cash provided by financing activities | 441,814 | 1,432 | | **Net increase in cash, cash equivalents, and restricted cash** | **36,930** | **69,934** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide details on the company's organization, accounting policies, and specifics on financial statement line items, including the FDA approval of CAPLYTA for bipolar depression in December 2021, a successful **$433.7 million** net proceeds public offering in January 2022, concentration of credit risk with three major wholesalers, and royalty commitments to Bristol-Myers Squibb (BMS) for lumateperone sales - In December 2021, the FDA approved CAPLYTA for treating depressive episodes in adults with bipolar I or II disorder, both as monotherapy and adjunctive therapy, following its initial approval for schizophrenia in December 2019[26](index=26&type=chunk) - On January 7, 2022, the company completed a public offering of common stock, raising net proceeds of approximately **$433.7 million** after expenses[27](index=27&type=chunk) - For Q1 2022, **97% of** product sales were to three major wholesalers, accounting for approximately **43%**, **28%**, and **26% of** sales, respectively[33](index=33&type=chunk) - The company is obligated to pay Bristol-Myers Squibb (BMS) tiered **single-digit percentage royalties (ranging from 5-9%)** on sales of licensed products like lumateperone[50](index=50&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management provides an overview of the business, focusing on the commercialization of CAPLYTA for schizophrenia and bipolar depression, and the progress of its clinical development pipeline, analyzing financial results for Q1 2022, highlighting significant revenue growth alongside increased R&D and SG&A expenses, and discussing the company's strong liquidity position following a recent stock offering and potential impacts from COVID-19 and other operational risks [Overview](index=18&type=section&id=Overview) The company is focused on commercializing CAPLYTA, which was approved for bipolar depression in December 2021, leading to an expansion of the sales force to approximately **320 representatives**, while the development pipeline for lumateperone is advancing with Phase 3 trials for Major Depressive Disorder (MDD) and a long-acting injectable (LAI) formulation, and other key programs include ITI-1284 for dementia-related behaviors, lenrispodun (ITI-214) for Parkinson's disease, and ITI-333 for substance use disorders - Following the December 2021 FDA approval of CAPLYTA for bipolar depression, the company expanded its sales force from approximately **240 to 320 representatives** to support the new indication's launch[58](index=58&type=chunk) - The company's pipeline includes lumateperone in Phase 3 for Major Depressive Disorder (MDD), a long-acting injectable (LAI) formulation of lumateperone, ITI-1284 for dementia-related agitation, lenrispodun for Parkinson's disease, and ITI-333 for substance use disorders[59](index=59&type=chunk)[61](index=61&type=chunk)[63](index=63&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) Total net revenues for Q1 2022 were **$35.0 million**, a significant increase from **$15.9 million** in Q1 2021, driven by CAPLYTA sales for both schizophrenia and the newly launched bipolar depression indication, while R&D expenses rose **93%** to **$29.0 million** due to increased clinical trial activity, and Selling, general, and administrative (SG&A) expenses increased **44%** to **$75.5 million**, reflecting higher commercialization costs, with the cost of product sales remaining favorably low as the company continues to sell inventory expensed as R&D prior to FDA approval | Account | Q1 2022 ($ thousands) | Q1 2021 ($ thousands) | Change (%) | | :--- | :--- | :--- | :--- | | **Total revenues, net** | **34,996** | **15,878** | **+120.4%** | | Cost of product sales | 3,155 | 1,455 | +116.8% | | Research and development | 29,043 | 15,058 | +92.9% | | Selling, general and administrative | 75,460 | 52,584 | +43.5% | | **Loss from operations** | **(72,662)** | **(53,219)** | **+36.5%** | | **Net loss** | **(72,119)** | **(52,740)** | **+36.7%** | - The increase in R&D expenses was primarily due to an **$8.9 million** increase for lumateperone clinical trials and a **$5.3 million** increase for other projects, including ITI-1284, ITI-214, and ITI-333 programs[88](index=88&type=chunk) - The increase in selling costs to **$56.1 million** from **$38.3 million** was driven by higher sales-related labor costs (**$7.6M**), marketing expenses (**$6.5M**), and travel costs (**$3.6M**) to support the commercialization of CAPLYTA[93](index=93&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) The company's financial position is strong, with approximately **$773.2 million** in cash, cash equivalents, and investments as of March 31, 2022, significantly bolstered by the **$433.7 million** in net proceeds from a January 2022 public stock offering, and management believes these funds are sufficient to cover operating expenses and capital requirements for at least the **next 12 months**, despite anticipating increased spending on the commercialization of CAPLYTA and ongoing clinical development programs - As of March 31, 2022, the company had a total of approximately **$773.2 million** in cash, cash equivalents, available-for-sale investment securities, and restricted cash[99](index=99&type=chunk) - A public offering of common stock completed on January 7, 2022, provided net proceeds of approximately **$433.7 million**[98](index=98&type=chunk) - The company expects its existing cash, cash equivalents, and marketable securities will be sufficient to fund operating expenses and capital expenditure requirements for at least the **next 12 months** from the filing date of this report[100](index=100&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company's primary market risks are identified as interest rate sensitivity, inflation, and capital market risk, with the main objective of its investment activities being capital preservation, and while rising interest rates led to a **$3.3 million** unrealized loss on investments as of March 31, 2022, the company does not expect to recognize these losses as it plans to hold investments to maturity, also acknowledging its dependence on capital markets for future funding - The company's primary market risk is interest rate sensitivity on its investment portfolio, with a recent increase in interest rates resulting in an unrealized loss of approximately **$3.3 million** as of March 31, 2022[118](index=118&type=chunk) - The company's ability to raise future funds depends on capital market forces affecting its stock price[120](index=120&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20CONTROLS%20AND%20PROCEDURES) The company's principal executive officer and principal financial officer evaluated the disclosure controls and procedures and concluded they were **effective** as of March 31, 2022, with **no changes** to the company's internal control over financial reporting identified during the quarter - The company's management, including the principal executive and financial officers, concluded that disclosure controls and procedures were **effective** as of the end of the period covered by the report[121](index=121&type=chunk) - There were **no changes** in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[122](index=122&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=29&type=section&id=Item%201.%20LEGAL%20PROCEEDINGS) The company states that it is **not a party to any material legal proceedings** - As of the filing date, the company is **not a party to any material legal proceedings**[124](index=124&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20RISK%20FACTORS) The company highlights its reliance on third parties for conducting clinical trials and notes that there have been no other material changes to the risk factors disclosed in its Annual Report, with a specific risk mentioned being the potential for delays and negative impacts on clinical trials due to political instability and conflict in regions like Ukraine and Russia, where the company has active clinical sites for its MDD and bipolar disorder programs - The company relies on third-party contract research organizations for clinical trials, and any failure on their part could lead to increased costs, delays, or prevention of commercialization[126](index=126&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) - The company has clinical trial sites in Ukraine and Russia for its MDD and bipolar disorder studies, and the ongoing conflict in the region poses a risk of delaying these trials and negatively affecting business operations[129](index=129&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section confirms that there were **no unregistered sales of equity securities** during the quarter, and the company did not repurchase any of its **equity securities** in the quarter ended March 31, 2022 - The company did not have any **unregistered sales of equity securities** during the quarter ended March 31, 2022[130](index=130&type=chunk) - The company did not repurchase any of its **equity securities** during the quarter ended March 31, 2022[131](index=131&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20EXHIBITS) This section lists the exhibits filed with the Form 10-Q, including the CEO and CFO certifications required by Sections 302 and 906 of the Sarbanes-Oxley Act, and the financial statements formatted in Inline XBRL - The report includes certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act of 2002[135](index=135&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 New York, New York 10016 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (646) 440-9333 Securities registered pursuant to ...

Financial Data and Key Metrics Changes - Total revenues for Q3 2021 grew to $22.2 million, compared to $7.4 million in Q3 2020 [11][28] - CAPLYTA net product revenues reached $21.6 million, up from $19 million in Q2 2021 and $7.4 million in Q3 2020 [11][28] - Net loss for Q3 2021 was $76.9 million, compared to a net loss of $55.2 million in Q3 2020 [30] Business Line Data and Key Metrics Changes - Total prescriptions for CAPLYTA increased by 15% quarter-over-quarter and approximately 200% year-over-year [11][22] - CAPLYTA's prescription growth trajectory continued despite disruptions from COVID-19 [11][22] Market Data and Key Metrics Changes - The upcoming FDA PDUFA date for CAPLYTA's label expansion into bipolar depression is December 17, 2021 [10][12] - There are over 11 million Americans living with bipolar disorder, representing a significant market opportunity for CAPLYTA [12][14] Company Strategy and Development Direction - The long-term vision is to establish lumateperone as the treatment of choice across a broad range of depressive disorders, starting with bipolar depression [14][16] - The company is expanding its salesforce from 240 to 320 representatives to enhance market presence [25][75] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial plan for CAPLYTA, anticipating strong uptake in prescriptions following the approval for bipolar depression [27][69] - The company noted that the COVID-19 pandemic has impacted patient engagement but is seeing improvements as vaccination rates increase [22][35] Other Important Information - The company ended Q3 2021 with $478.7 million in cash and equivalents, down from $658.8 million at the end of 2020 [30][21] - Research and Development expenses for Q3 2021 were $27 million, significantly higher than $10.3 million in Q3 2020 due to increased clinical trial costs [29] Q&A Session Summary Question: How is the commercial landscape shifting with COVID-19? - Management noted that as COVID-19 cases decrease and vaccination rates increase, more psychiatry offices are reopening, allowing for greater access for the salesforce [35] Question: What is the status of the PDUFA date? - Management confirmed that everything is on track for the PDUFA date of December 17, 2021 [37][41] Question: How will the launch dynamics for bipolar depression be affected by other launches? - Management indicated that they are focused on their launch and have a comprehensive commercial plan in place [44] Question: What are the expectations for the baseline MADRS scores in the depression study? - Management expects baseline scores to be in the range of 28 to 30 [49] Question: What is the gross to net ratio for CAPLYTA? - The gross to net ratio has been consistent, expected to remain in the mid-20s to low 30s range [58] Question: How will the company track prescriptions for schizophrenia versus bipolar depression? - Management stated that there are data sources available to track prescriptions by indication, although they are not perfect [66] Question: What are the expectations for the pace of the bipolar depression launch post-approval? - Management plans to launch immediately upon approval, although they do not expect a significant spike in prescriptions during the holiday weeks [78] Question: How does the company view xUS opportunities? - Management indicated that they will focus on the bipolar indication first before exploring xUS opportunities [90]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36274 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b ...

CAPLYTA (Lumateperone) - CAPLYTA is FDA-approved for the treatment of schizophrenia in adults[6] - The company is seeking approval for lumateperone for bipolar depression, with sNDAs under review by the FDA and a PDUFA action date of December 17, 2021[6, 36] - The company is expanding lumateperone development with late-stage programs in additional depressive disorders, including adjunctive treatment of Major Depressive Disorder (MDD) and Bipolar depression and MDD with mixed features[6] - In a 1-year open-label trial, schizophrenia symptoms remained stable and the mean change in body weight was approximately -3.2 kg (~7 lbs) at Day 350[30] Market and Prevalence - Approximately 24 million adults in the U S live with schizophrenia[26, 28] - Approximately 11 million adults in the U S live with bipolar disorder, representing 4 4% lifetime prevalence[26, 34] - Approximately 17 3 million adults in the U S have at least one depressive episode[26, 45] - About 1/3 of patients with MDD and bipolar depression exhibit mixed features[26, 49] - Approximately 74% of patients discontinue schizophrenia treatment within 18 months of initiation[28] Pipeline and Financials - The company had $556 2 million in total cash, cash equivalents, and investments as of June 30, 2021[63] - The company had $0 0 million in total debt as of June 30, 2021[63]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36274 INTRA-CELLULAR THERAPIES, INC. (Exact name of registrant as specified in its charter) Delaware 36-474285 ...

Corporate Presentation May 2021 Safe Harbor Statement 2 This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements are based ...