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Intra-Cellular Therapies(ITCI) - 2022 Q2 - Quarterly Report
2022-08-09 11:47
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 ...
Intra-Cellular Therapies(ITCI) - 2022 Q1 - Quarterly Report
2022-05-10 11:46
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 March 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 Securities registered pursuant to Section 12(b) of the Act: | | Trading | Name of each exchange | | --- | --- | --- | | Title of each cla ...
Intra-Cellular Therapies(ITCI) - 2021 Q4 - Annual Report
2022-03-01 12:46
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 ...
Intra-Cellular Therapies(ITCI) - 2021 Q3 - Quarterly Report
2021-11-09 12:53
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 ...
Intra-Cellular Therapies(ITCI) - 2021 Q2 - Quarterly Report
2021-08-09 11:31
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 ...
Intra-Cellular Therapies(ITCI) - 2021 Q1 - Quarterly Report
2021-05-10 11:31
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 March 31, 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 430 East 29th Street New York, New York 10016 (Address of principal executive offices) (Zip Code) (I.R. ...
Intra-Cellular Therapies(ITCI) - 2020 Q4 - Earnings Call Transcript
2021-02-25 19:47
Financial Data and Key Metrics Changes - In Q4 2020, net product revenues of CAPLYTA were $12.4 million, up from $7.4 million in Q3 2020, with total revenues for the year at $22.8 million [36][37] - Research and development expenses decreased to $14.3 million in Q4 2020 from $19.1 million in Q4 2019, while selling, general and administrative expenses increased to $58.3 million from $22.8 million in the same period [36][38] - The net loss for Q4 2020 was $60.7 million, compared to a net loss of $40.6 million in Q4 2019, with a total net loss for the year of $227 million or $3.23 per share [39] Business Line Data and Key Metrics Changes - CAPLYTA experienced a 77% growth in prescriptions in Q4 2020 compared to Q3 2020, indicating strong market performance despite COVID-19 challenges [16][30] - The company is pursuing label expansion for CAPLYTA to include indications for bipolar depression, with a supplemental new drug application submitted [11][19] Market Data and Key Metrics Changes - CAPLYTA's market access position is strong, with coverage exceeding 95% of covered lives in Medicare Part D and state Medicaid, representing a significant portion of schizophrenia prescriptions [28] - The overall antipsychotic market remained flat due to COVID-19, yet CAPLYTA's prescription growth continued, suggesting resilience in its market performance [30] Company Strategy and Development Direction - The company aims to expand its CAPLYTA label for bipolar depression and continue late-stage development programs for Lumateperone in depressive disorders [11][20] - The company is also advancing its Long Acting Injectable formulation of Lumateperone and exploring new programs such as ITI-1284 for elderly patients [22][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of CAPLYTA and anticipates a strong build in revenues throughout 2021, particularly in the second half as COVID-19 disruptions improve [71] - The company highlighted the significant unmet medical need in neuropsychiatric conditions and the potential of Lumateperone to address these needs [15][94] Other Important Information - The company ended 2020 with approximately $659 million in cash, cash equivalents, and investments, providing a strong financial position for future growth [26][39] - The company is preparing for potential label expansion in bipolar depression and is optimistic about the reception of its products in the market [34][62] Q&A Session Summary Question: Could you give us some color on the data package for the bipolar depression sNDA? - Management confirmed that updated information on UGT interaction was submitted and no interactions were observed, which is positive news [43][44] Question: What are your goals for new prescribers versus deepening existing prescriber use? - The company aims to extend both the breadth of prescribers and deepen existing prescriber use of CAPLYTA, supported by positive feedback from patients and physicians [50] Question: How comfortable are you with consensus numbers for 2021 revenue? - Management expressed comfort with consensus numbers around $110 million, anticipating strong revenue growth as COVID disruptions improve [71] Question: What is the expected timeline for the MDD program? - The company expects to initiate clinical studies for major depressive disorder this year, with a typical two-year enrollment and readout timeline [87] Question: How does the PK profile of 1284 compare with lumateperone? - Management indicated that 1284 has advantages for elderly patients due to its rapid absorption and metabolic stability, which are beneficial for the targeted indications [72]
Intra-Cellular Therapies(ITCI) - 2020 Q4 - Annual Report
2021-02-25 12:46
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, 2020 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 ...
Intra-Cellular Therapies(ITCI) - 2020 Q3 - Quarterly Report
2020-11-09 12:45
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, 2020 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 36-4 ...
Intra-Cellular Therapies(ITCI) - 2020 Q2 - Quarterly Report
2020-08-10 12:17
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, 2020 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 ...