000156751412-312024Q3false14098104xbrli:sharesiso4217:USDiso4217:USDxbrli:sharesitci:segmentxbrli:pure00015675142024-01-012024-09-3000015675142024-10-2800015675142024-09-3000015675142023-12-310001567514us-gaap:ProductMember2024-07-012024-09-300001567514us-gaap:ProductMember2023-07-012023-09-300001567514us-gaap:ProductMember2024-01-012024-09-300001567514us-gaap:ProductMember2023-01-012023-09-300001567514us-gaap:GrantMember2024-07-012024-09-300001567514us-gaap:GrantMember2023-07-012023-09-300001567514us-gaap:GrantMember2024-01-012024-09-300001567514us-gaap:GrantMember2023-01-012023-09-3000015675142024-07-012024-09-3000015675142023-07-012023-09-3000015675142023-01-012023-09-300001567514us-gaap:CommonStockMember2022-12-310001567514us-gaap:AdditionalPaidInCapitalMember2022-12-310001567514us-gaap:RetainedEarningsMember2022-12-310001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-12-3100015675142022-12-310001567514us-gaap:CommonStockMember2023-01-012023-03-310001567514us-gaap:AdditionalPaidInCapitalMember2023-01-012023-03-3100015675142023-01-012023-03-310001567514us-gaap:RetainedEarningsMember2023-01-012023-03-310001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-01-012023-03-310001567514us-gaap:CommonStockMember2023-03-310001567514us-gaap:AdditionalPaidInCapitalMember2023-03-310001567514us-gaap:RetainedEarningsMember2023-03-310001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-03-3100015675142023-03-310001567514us-gaap:CommonStockMember2023-04-012023-06-300001567514us-gaap:AdditionalPaidInCapitalMember2023-04-012023-06-3000015675142023-04-012023-06-300001567514us-gaap:RetainedEarningsMember2023-04-012023-06-300001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-04-012023-06-300001567514us-gaap:CommonStockMember2023-06-300001567514us-gaap:AdditionalPaidInCapitalMember2023-06-300001567514us-gaap:RetainedEarningsMember2023-06-300001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-06-3000015675142023-06-300001567514us-gaap:CommonStockMember2023-07-012023-09-300001567514us-gaap:AdditionalPaidInCapitalMember2023-07-012023-09-300001567514us-gaap:RetainedEarningsMember2023-07-012023-09-300001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-07-012023-09-300001567514us-gaap:CommonStockMember2023-09-300001567514us-gaap:AdditionalPaidInCapitalMember2023-09-300001567514us-gaap:RetainedEarningsMember2023-09-300001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-09-3000015675142023-09-300001567514us-gaap:CommonStockMember2023-12-310001567514us-gaap:AdditionalPaidInCapitalMember2023-12-310001567514us-gaap:RetainedEarningsMember2023-12-310001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-12-310001567514us-gaap:CommonStockMember2024-01-012024-03-310001567514us-gaap:AdditionalPaidInCapitalMember2024-01-012024-03-3100015675142024-01-012024-03-310001567514us-gaap:RetainedEarningsMember2024-01-012024-03-310001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-01-012024-03-310001567514us-gaap:CommonStockMember2024-03-310001567514us-gaap:AdditionalPaidInCapitalMember2024-03-310001567514us-gaap:RetainedEarningsMember2024-03-310001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-03-3100015675142024-03-310001567514us-gaap:CommonStockMember2024-04-012024-06-300001567514us-gaap:AdditionalPaidInCapitalMember2024-04-012024-06-3000015675142024-04-012024-06-300001567514us-gaap:RetainedEarningsMember2024-04-012024-06-300001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-04-012024-06-300001567514us-gaap:CommonStockMember2024-06-300001567514us-gaap:AdditionalPaidInCapitalMember2024-06-300001567514us-gaap:RetainedEarningsMember2024-06-300001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-06-3000015675142024-06-300001567514us-gaap:CommonStockMember2024-07-012024-09-300001567514us-gaap:AdditionalPaidInCapitalMember2024-07-012024-09-300001567514us-gaap:RetainedEarningsMember2024-07-012024-09-300001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-07-012024-09-300001567514us-gaap:CommonStockMember2024-09-300001567514us-gaap:AdditionalPaidInCapitalMember2024-09-300001567514us-gaap:RetainedEarningsMember2024-09-300001567514us-gaap:AccumulatedOtherComprehensiveIncomeMember2024-09-3000015675142024-04-012024-04-3000015675142024-04-300001567514itci:ThreeMajorWholesalersMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:SalesRevenueNetMember2024-01-012024-09-300001567514itci:CustomerOneMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:SalesRevenueNetMember2024-01-012024-09-300001567514itci:CustomerTwoMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:SalesRevenueNetMember2024-01-012024-09-300001567514itci:CustomerThreeMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:SalesRevenueNetMember2024-01-012024-09-300001567514itci:CustomerOneMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:SalesRevenueNetMember2023-01-012023-09-300001567514itci:CustomerTwoMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:SalesRevenueNetMember2023-01-012023-09-300001567514itci:CustomerThreeMemberus-gaap:CustomerConcentrationRiskMemberus-gaap:SalesRevenueNetMember2023-01-012023-09-300001567514us-gaap:USGovernmentAgenciesDebtSecuritiesMember2024-09-300001567514itci:FDICCertificatesOfDepositMember2024-09-300001567514us-gaap:CertificatesOfDepositMember2024-09-300001567514us-gaap:CommercialPaperMember2024-09-300001567514us-gaap:CorporateDebtSecuritiesMember2024-09-300001567514us-gaap:USGovernmentAgenciesDebtSecuritiesMember2023-12-310001567514itci:FDICCertificatesOfDepositMember2023-12-310001567514us-gaap:CertificatesOfDepositMember2023-12-310001567514us-gaap:CommercialPaperMember2023-12-310001567514us-gaap:CorporateDebtSecuritiesMember2023-12-310001567514us-gaap:DebtSecuritiesMember2024-09-300001567514us-gaap:DebtSecuritiesMember2023-12-310001567514us-gaap:FairValueInputsLevel3Member2023-12-310001567514us-gaap:FairValueInputsLevel3Member2024-09-300001567514us-gaap:CashAndCashEquivalentsMember2024-09-300001567514us-gaap:CashAndCashEquivalentsMember2023-12-310001567514us-gaap:FairValueMeasurementsRecurringMemberus-gaap:MoneyMarketFundsMember2024-09-300001567514us-gaap:FairValueInputsLevel1Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel2Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel3Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USGovernmentAgenciesDebtSecuritiesMember2024-09-300001567514us-gaap:FairValueInputsLevel1Memberus-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel2Memberus-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel3Memberus-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueMeasurementsRecurringMemberitci:FDICCertificatesOfDepositMember2024-09-300001567514us-gaap:FairValueInputsLevel1Memberitci:FDICCertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel2Memberitci:FDICCertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel3Memberitci:FDICCertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CertificatesOfDepositMember2024-09-300001567514us-gaap:FairValueInputsLevel1Memberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel2Memberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel3Memberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CommercialPaperMember2024-09-300001567514us-gaap:FairValueInputsLevel1Memberus-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel2Memberus-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel3Memberus-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CorporateDebtSecuritiesMember2024-09-300001567514us-gaap:FairValueInputsLevel1Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel3Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2024-09-300001567514us-gaap:FairValueMeasurementsRecurringMemberus-gaap:MoneyMarketFundsMember2023-12-310001567514us-gaap:FairValueInputsLevel1Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel2Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel3Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueMeasurementsRecurringMemberus-gaap:USGovernmentAgenciesDebtSecuritiesMember2023-12-310001567514us-gaap:FairValueInputsLevel1Memberus-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel2Memberus-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel3Memberus-gaap:USGovernmentAgenciesDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueMeasurementsRecurringMemberitci:FDICCertificatesOfDepositMember2023-12-310001567514us-gaap:FairValueInputsLevel1Memberitci:FDICCertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel2Memberitci:FDICCertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel3Memberitci:FDICCertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CertificatesOfDepositMember2023-12-310001567514us-gaap:FairValueInputsLevel1Memberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel2Memberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel3Memberus-gaap:CertificatesOfDepositMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CommercialPaperMember2023-12-310001567514us-gaap:FairValueInputsLevel1Memberus-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel2Memberus-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel3Memberus-gaap:CommercialPaperMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueMeasurementsRecurringMemberus-gaap:CorporateDebtSecuritiesMember2023-12-310001567514us-gaap:FairValueInputsLevel1Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel2Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel3Memberus-gaap:CorporateDebtSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2023-12-310001567514stpr:NY2018-09-300001567514stpr:NJ2024-05-310001567514us-gaap:VehiclesMember2024-09-300001567514itci:BristolMyersSquibbCompanyMemberus-gaap:ProductMember2005-05-312024-09-300001567514itci:BristolMyersSquibbCompanyMemberus-gaap:ProductMember2024-09-300001567514itci:BristolMyersSquibbCompanyMemberus-gaap:ProductMember2005-05-310001567514itci:BristolMyersSquibbCompanyMemberus-gaap:ProductMembersrt:MinimumMember2005-05-312005-05-310001567514itci:BristolMyersSquibbCompanyMemberus-gaap:ProductMembersrt:MaximumMember2005-05-312005-05-310001567514itci:BristolMyersSquibbCompanyMemberus-gaap:ProductMember2024-01-012024-09-300001567514us-gaap:PurchaseCommitmentMember2024-09-300001567514us-gaap:PurchaseCommitmentMember2023-12-310001567514itci:InventoriableCostsMember2024-07-012024-09-300001567514itci:InventoriableCostsMember2023-07-012023-09-300001567514itci:InventoriableCostsMember2024-01-012024-09-300001567514itci:InventoriableCostsMember2023-01-012023-09-300001567514us-gaap:SellingGeneralAndAdministrativeExpensesMember2024-07-012024-09-300001567514us-gaap:SellingGeneralAndAdministrativeExpensesMember2023-07-012023-09-300001567514us-gaap:SellingGeneralAndAdministrativeExpensesMember2024-01-012024-09-300001567514us-gaap:SellingGeneralAndAdministrativeExpensesMember2023-01-012023-09-300001567514us-gaap:ResearchAndDevelopmentExpenseMember2024-07-012024-09-300001567514us-gaap:ResearchAndDevelopmentExpenseMember2023-07-012023-09-300001567514us-gaap:ResearchAndDevelopmentExpenseMember2024-01-012024-09-300001567514us-gaap:ResearchAndDevelopmentExpenseMember2023-01-012023-09-3000015675142023-01-012023-12-310001567514us-gaap:RestrictedStockUnitsRSUMember2023-12-310001567514us-gaap:RestrictedStockUnitsRSUMember2023-01-012023-12-310001567514us-gaap:RestrictedStockUnitsRSUMember2024-01-012024-09-300001567514us-gaap:RestrictedStockUnitsRSUMember2024-09-300001567514itci:TimeBasedRestrictedStockUnitsRSUMember2024-09-300001567514us-gaap:EmployeeStockOptionMember2024-01-012024-09-300001567514us-gaap:EmployeeStockOptionMember2024-07-012024-09-300001567514us-gaap:EmployeeStockOptionMember2023-07-012023-09-300001567514us-gaap:EmployeeStockOptionMember2023-01-012023-09-300001567514us-gaap:RestrictedStockUnitsRSUMember2024-01-012024-09-300001567514us-gaap:RestrictedStockUnitsRSUMember2024-07-012024-09-300001567514us-gaap:RestrictedStockUnitsRSUMember2023-01-012023-09-300001567514us-gaap:RestrictedStockUnitsRSUMember2023-07-012023-09-300001567514itci:MichaelI.HalsteadTradingArrangementAug13PlanMemberitci:MichaelIHalsteadMember2024-07-012024-09-300001567514itci:MichaelI.HalsteadTradingArrangementAug13PlanMemberitci:MichaelIHalsteadMember2024-09-300001567514itci:MichaelI.HalsteadTradingArrangementJan2PlanMemberitci:MichaelIHalsteadMember2024-07-012024-09-300001567514itci:MichaelI.HalsteadTradingArrangementJan2PlanMemberitci:MichaelIHalsteadMember2024-09-300001567514itci:SharonMatesPh.DMember2024-07-012024-09-300001567514itci:SharonMatesPh.DMember2024-09-30
目錄
美國
證券交易委員會
華盛頓特區 20549
_______________________
表格 10-Q
_______________________
（標記1）
x根據美國證券交易法第13或15(d)條規定提交的季度報告
截至季度結束日期的財務報告2024年9月30日
或
o根據美國證券交易法第13或15(d)條規定的過渡報告
轉換期從______到______
委託文件編號：001-39866001-36274
_______________________
Intra-Cellular Therapies, Inc.
(根據其章程規定的發行人的確切名稱)
_______________________
特拉華州36-4742850
（國家或其他管轄區的
公司成立或組織）
（IRS僱主
唯一識別號碼）
 
135 Route 202/206，6號套房
Bedminster, 新澤西州。
07921
，（主要行政辦公地址）(郵政編碼)
(646) 440-9333
（如果自上次報告以來有變化，則填上其曾用名或舊地址）
_______________________
根據法案第12（b）條註冊的證券：
每一類的名稱
交易
符號:
普通股，每股面值$0.001
ANNX
普通股intra-cellular therapies
本基金尋求於東歐地區註冊的主要權益關聯發行人的長期升值投資。納斯達克資本市場全球貨幣選擇市場
請勾選以下選項以指示註冊人是否在過去12個月內(或在註冊人需要提交此類報告的較短時間內)已提交證券交易法1934年第13或15(d)條所要求提交的所有報告，並且在過去90天內已受到此類報告提交要求的影響。是 x否o
請在以下勾選方框表示註冊人是否已在Regulation S-T Rule 405規定的前12個月(或在註冊人需要提交此類文件的較短期間內)提交了每個互動數據文件。是 x否o
請勾選此項，指示註冊人是否爲大型加速申報人、加速申報人、非加速申報人、小型報告公司或新興增長公司。有關「大型加速申報人」、「加速申報人」、「小型報告公司」和「新興增長公司」的定義，請參見《交易法規1.2》條。
大型加速報告人☒加速文件提交人o
 
非加速文件提交人o較小的報告公司o
 
  新興成長公司o
如果是新興成長型企業，請勾選複選標記，表明註冊者已選擇不使用延長過渡期來符合根據證券交易法第13(a)條規定提供的任何新財務會計準則。 o
請勾選以下選項以指示註冊人是否爲外殼公司(根據交易所法規則12b-2定義)。是o否x
截至2024年10月28日，註冊人擁有 106,017,103 股普通股未實發行。

目錄
Intra-Cellular Therapies, Inc.
第10-Q表的索引
本季度報告書中，「我們」、「我們的」、「公司」一詞是指Intra-Cellular Therapies，Inc.和我們的子公司。「ITI」是指我們的全資子公司ITI, Inc。
i
目錄
第一部分：財務信息
第1項 基本報表
Intra-Cellular Therapies，Inc.和子公司
彙編的資產負債表（除股本和每股股價以外的數值均以千爲單位）
2024年9月30日2023年12月31日
(未經審計)
資產
流動資產：
現金及現金等價物$464,312 $147,767 
投資證券，可供出售542,250 350,174 
受限現金1,750 1,750 
2,687,823 145,608 114,018 
庫存23,539 11,647 
預付費用和其他流動資產94,272 42,443 
總流動資產1,271,731 667,799 
資產和設備，淨值2,005 1,654 
使用權資產，淨額14,011 12,928 
非流動庫存30,479 38,621 
其他6,219 7,293 
總資產$1,324,445 $728,295 
負債和股東權益
流動負債:
應付賬款$10,338 $11,452 
應計及其他流動負債51,540 27,944 
31,80170,536 53,173 
應計員工福利29,496 27,364 
經營租賃負債4,203 3,612 
流動負債合計166,113 123,545 
非流動經營租賃負債13,506 13,326 
負債合計179,619 136,871 
股東權益:
普通股，每股面值爲 $0.0001；0.0001股份在2023年9月30日和2022年12月31日分別授權;175,000,000 分別於2024年9月30日和2023年12月31日授權的股份； 105,998,786和頁面。96,379,811 而9月30日和2023年12月31日分別發行和流通的股份
11 10 
額外實收資本2,818,137 2,208,470 
累積赤字(1,674,951)(1,617,160)
累計綜合收益
1,629 104 
股東權益總額1,144,826 591,424 
負債和股東權益總額$1,324,445 $728,295 
詳細的財務報表註解請參見本壓縮合並財務報表的附註部分。
1
目錄
Intra-Cellular Therapies，Inc.和子公司
簡明合併利潤表（以千爲單位，除股份和每股金額外）（未經審計）
截至9月30日的三個月截至9月30日的九個月
2024202320242023
收入
產品銷售額，淨額$175,159 $125,810 $481,278 $330,669 
補助金收入216 363 351 1,602 
總收入，淨額175,375 126,173 481,629 332,271 
運營費用：
產品銷售成本15,304 9,129 36,558 23,043 
銷售、一般和管理132,101 105,207 366,760 305,144 
研究和開發66,819 41,550 165,835 129,368 
運營費用總額214,224 155,886 569,153 457,555 
運營損失(38,849)(29,713)(87,524)(125,284)
利息收入12,899 5,498 30,523 14,377 
所得稅準備金前的虧損(25,950)(24,215)(57,001)(110,907)
所得稅支出(374)(43)(790)(188)
淨虧損$(26,324)$(24,258)$(57,791)$(111,095)
每股普通股淨虧損：
基礎版和稀釋版$(0.25)$(0.25)$(0.57)$(1.16)
加權平均普通股數量：
基礎版和稀釋版105,768,38696,143,083102,135,53095,745,641
請參閱本壓縮合並財務報表的附註。
2
目錄
Intra-Cellular Therapies，Inc.和子公司
簡明綜合損失表（以千爲單位）（未經審計）
截至9月30日的三個月截至9月30日的九個月
2024202320242023
淨虧損$(26,324)$(24,258)$(57,791)$(111,095)
其他綜合收益：
投資證券的未實現收益
2,297 933 1,525 2,855 
綜合損失$(24,027)$(23,325)$(56,266)$(108,240)
詳細的財務報表註解請參見本壓縮合並財務報表的附註部分。
3
目錄
Intra-Cellular Therapies，Inc.和子公司
股東權益簡明綜合表（以千爲單位，除股份和每股金額外）（未經審計）
普通股額外
付費
資本		累積
赤字		累積
全面
（虧損）收入		總計
股東
股權
股票金額
截至2022年12月31日的餘額94,829,794$9 $2,137,737 $(1,477,486)$(4,190)$656,070 
行使股票期權和發行限制性股票849,8271 3,639 — — 3,640 
爲服務而發行的股票408— 22 — — 22 
基於股份的薪酬—— 10,439 — — 10,439 
淨虧損—— — (44,053)— (44,053)
其他綜合收益—— — — 1,492 1,492 
截至2023年3月31日的餘額95,680,029$10 $2,151,837 $(1,521,539)$(2,698)$627,610 
行使股票期權和發行限制性股票402,994— 8,585 — — 8,585 
爲服務而發行的股票364— 23 — — 23 
基於股份的薪酬—— 13,226 — — 13,226 
淨虧損—— — (42,784)— (42,784)
其他綜合收益—— — — 430 430 
截至 2023 年 6 月 30 日的餘額96,083,387$10 $2,173,671 $(1,564,323)$(2,268)$607,090 
行使股票期權和發行限制性股票141,780— 2,581 — — 2,581 
爲服務而發行的股票450— 24 — — 24 
基於股份的薪酬—— 14,311 — — 14,311 
淨虧損—— — (24,258)— (24,258)
其他綜合收益
—— — — 933 933 
截至 2023 年 9 月 30 日的餘額96,225,617$10 $2,190,587 $(1,588,581)$(1,335)$600,681 

Intra-Cellular Therapies, Inc. and Subsidiary
Condensed Consolidated Statements of Stockholders’ Equity (in thousands except share and per share amounts) (Unaudited) (continued)
普通股額外的實收資本累計赤字累計綜合（虧損）收益股東權益總額
股票金額
截至2023年12月31日的餘額96,379,811$10 $2,208,470 $(1,617,160)$104 $591,424 
行使股票期權和發行限制性股票1,097,668— 9,989 — — 9,989 
爲服務而發行的股票339— 23 — — 23 
基於股份的薪酬—— 13,843 — — 13,843 
淨虧損—— — (15,247)— (15,247)
其他綜合損失—— — — (534)(534)
截至 2024 年 3 月 31 日的餘額97,477,818$10 $2,232,325 $(1,632,407)$(430)$599,498 
已發行的普通股7,876,7131 543,085 — — 543,086 
行使股票期權和發行限制性股票270,026— 2,093 — — 2,093 
爲服務而發行的股票345— 23 — — 23 
基於股份的薪酬—— 16,370 — — 16,370 
淨虧損—— — (16,220)— (16,220)
其他綜合損失—— — — (238)(238)
截至 2024 年 6 月 30 日的餘額105,624,902$11 $2,793,896 $(1,648,627)$(668)$1,144,612 
行使股票期權和發行限制性股票373,638— 6,734 — — 6,734 
爲服務而發行的股票246— 18 — — 18 
基於股份的薪酬—— 17,489 — — 17,489 
淨虧損—— — (26,324)— (26,324)
其他綜合收益—— — — 2,297 2,297 
截至 2024 年 9 月 30 日的餘額105,998,786$11 $2,818,137 $(1,674,951)$1,629 $1,144,826 

詳細的財務報表註解請參見本壓縮合並財務報表的附註部分。
4
目錄
Intra-Cellular Therapies，Inc.和子公司
現金流量表摘要（以千爲單位）（未經審計）
截至9月30日的九個月
20242023
經營活動中使用的現金流
淨虧損$(57,791)$(111,095)
爲使淨虧損與經營活動中使用的淨現金相一致而進行的調整：
折舊399 392 
基於股份的薪酬47,702 37,976 
爲服務而發行的股票64 69 
投資證券的保費攤銷和折扣的增加，淨額(6,043)(5,861)
運營資產和負債的變化：
應收賬款，淨額(31,590)(27,481)
庫存(3,750)(19,066)
預付費用和其他資產(50,755)(16,805)
應付賬款(1,114)218 
應計負債和其他流動負債23,596 8,172 
應計客戶計劃17,363 9,997 
應計員工福利2,132 2,452 
經營租賃負債，淨額(312)(1,106)
用於經營活動的淨現金(60,099)(122,138)
投資活動提供的（用於）現金流
購買投資(482,077)(310,805)
投資的到期日297,568 369,192 
購買財產和設備(749)(268)
投資活動提供的（用於）淨現金
(185,258)58,119 
融資活動提供的現金流
行使股票期權的收益18,816 14,806 
出售普通股的收益，淨額
543,086 — 
融資活動提供的淨現金561,902 14,806 
現金、現金等價物和限制性現金的淨增加（減少）
316,545 (49,213)
期初的現金、現金等價物和限制性現金149,517 150,365 
期末現金、現金等價物和限制性現金$466,062 $101,152 
非現金投資和融資活動
運營租賃下的資產的使用權$2,548 $— 
補充現金流信息
繳納稅款的現金
$1,364 $— 
5
目錄
下表提供了現金、現金等價物和受限制現金的調節，該調節是在簡明的綜合資產負債表中報告的，這些項目總和等於簡明的現金流量表中所示的相同金額總和：
2020年9月30日
20242023
現金及現金等價物$464,312 $99,402 
受限現金1,750 1,750 
現金、現金等價物和受限制的現金總額$466,062 $101,152 
詳細的財務報表註解請參見本壓縮合並財務報表的附註部分。
6
目錄
Intra-Cellular Therapies, Inc.
簡要財務報表註釋（未經審計）
2024年9月30日
1. 組織
Intra-Cellular Therapies, Inc.（以下簡稱「公司」）通過其全資子公司ITI, Inc.（以下簡稱「ITI」）是一家專注於發現、臨床開發和商業化能夠主要滿足精神和神經系統疾病的創新小分子藥物的生物製藥公司。 2019年12月，美國食品和藥物管理局（the U.S. Food and Drug Administration，「FDA」）批准了治療成人精神分裂症的CAPLYTA®（lumateperone）（42 毫克/日），公司在2020年3月開展了CAPLYTA的商業化推廣。2021年12月，CAPLYTA被FDA批准治療成人雙相情感障礙（42毫克/日），公司開展了CAPLYTA治療雙相情感障礙的商業化推廣。此外，2022年4月，FDA批准CAPLYTA的兩個額外劑量，即10.5毫克和21毫克膠囊，以爲正在同時服用強力或中度CYP3A4抑制劑的患者提供劑量推薦，以及爲肝功能中度或重度受損（Child-Pugh乙或丙級）的患者提供21毫克膠囊。這些特殊人群劑量的商業化推廣始於2022年8月。在「簡明的綜合資產負債表註釋」中使用的「CAPLYTA」是指美國 FDA 批准治療成人精神分裂症和成人雙相情感障礙的lumateperone，「lumateperone」是指CAPLYTA以及超越精神分裂症和雙相情感障礙的其他適應症的lumateperone。
2024年4月，公司完成了一次公開發行普通股，公司出售了 7,876,713每股公開發行價爲$22.66。本次發行的總毛收益約爲$73.00每股募集資金總額爲$575.0百萬美元。扣除承銷折扣、佣金和發行費用後，公司的淨收益約爲543.1股票回購活動以及因員工基於股票的補償目的而重新發行國庫股的情況如下：
2. 重要會計政策摘要
報告前提
Intra-Cellular Therapies, Inc. 及其全資子公司的附註簡明的綜合財務報表是按照美國公認會計原則（「GAAP」）編制的。這些附註中對適用指南的任何引用都是指有約束力的美國 GAAP，這些 GAAP 規定在財務會計準則法規編碼（「ASC」）和 Gold Amendments 中的會計準則更新中闡述。所有子公司之間的帳戶和交易都已在合併時予以消除。本公司目前在一家 之一 個經營板塊中運營。經營板塊是指企業組成部分，有關該部分的獨立數據可以供首席經營決策者或決策組使用，以便決定如何分配資源和評估績效。本公司將其業務視爲由一個個組成部分的 之一 板塊組成，該板塊發現、開發和商業化主要滿足精神和神經系統疾病的藥物。
近期會計準則
2023年11月，FASb發佈了ASU 2023-07，分段報告（主題280）:報告業務板塊披露的改進要求公衆實體按照期中和年度的要求披露其報告範圍內的重要費用和其他部分項目的信息。只有一個報告範圍的公衆實體也需要遵守披露要求。該標準適用於2023年12月15日後開始的年度報告期和2025年1月1日後開始的期中報告期，允許提前採納。公司目前正在評估這一新標準對其合併財務報表和相關披露可能產生的影響。
估算的使用
按照 GAAP 編制財務報表要求管理層進行估計和假設，這些估計和假設會影響到財務報表和附註中報告的金額。雖然實際結果可能會與這些估計有所不同，但管理層認爲此類差異不會發生重大影響。
7
目錄
除了下面的說明，公司的重要會計政策在我們的2023財年年度報告中已經描述，這些政策對這些簡化合並財務報表和相關附註產生了重大影響。
本公司在其提供中期財務報告的會計政策與年報Form10-k中的 Note 2中所展示的會計政策是一致的。
信用風險集中度
潛在使公司面臨信用風險集中的金融工具包括來自客戶的應收賬款淨額和存放在金融機構的現金、現金等價物和投資證券。截至2024年9月30日的九個月期間， 98%的產品銷售收入。
三個個別客戶分別佔了約 37%, 33%和28%以及 36%, 32%和29截至2024年9月30日止九個月期間的產品銷售額分別爲2024年和2023年。截至2024年9月30日，公司仍然相信這些客戶信用質量高。
現金等價物存放在美國主要金融機構中。存放在銀行的定期存款、現金和現金等價物可能超過這些存款上提供的保險金額。通常，這些存款可以隨時贖回，因此承擔的風險很小。
3. 投資證券
投資證券包括以下內容（以千爲單位）：
2024年9月30日
攤銷
成本		未實現
收益		未實現
（損失）		估計的
公平
價值
美國政府機構證券$135,801 $158 $(13)$135,946 
聯邦存款保險公司存款證980 — — 980 
存款證60,000 — — 60,000 
商業票據51,637 63 (1)51,699 
公司票據/債券315,499 1,453 (31)316,921 
$563,917 $1,674 $(45)$565,546 
2023 年 12 月 31 日
攤銷
成本		未實現
收益		未實現
（損失）		估計的
公平
價值
美國政府機構證券$150,651 $148 $(204)$150,595 
聯邦存款保險公司存款證4,410 2 (12)4,400 
存款證60,000 — — 60,000 
商業票據78,610 59 (27)78,642 
公司票據/債券118,899 281 (143)119,037 
$412,570 $490 $(386)$412,674 
公司已將其所有投資證券分類爲可供出售，包括那些到期日期超過一年的證券，在簡明合併資產負債表中作爲流動資產，基於投資證券具有高度流動性的特性，並且這些投資證券被視爲可供當前業務使用。截至2024年9月30日和2023年12月31日，公司持有$164.0萬美元和77.8 百萬美元的可供出售投資證券，其中合同到期日超過一年但不足兩年，其餘的可供出售投資證券合同到期日不足一年。截至2024年9月30日和2023年12月31日，投資證券應計利息應收款爲$3.7萬美元和2.3 xx百萬美元的應計利息分別來自證券投資，已包括於預付費用和其他流動資產內。
8
目錄
截至2024年9月30日，投資相關的未實現損失的權益的總體公允價值爲$66.2 投資中未實現損失的相關公允價值爲xx百萬美元，其中包括xx百萬美元的美國政府機構證券投資，xx百萬美元的存單，xx百萬美元的商業票據和xx百萬美元的企業票/債券。30.5 投資中未實現損失的相關公允價值爲xx百萬美元，其中包括xx百萬美元的美國政府機構證券投資，xx百萬美元的存單，xx百萬美元的商業票據和xx百萬美元的企業票/債券。6.0 投資中未實現損失的相關公允價值爲xx百萬美元，其中包括xx百萬美元的美國政府機構證券投資，xx百萬美元的存單，xx百萬美元的商業票據和xx百萬美元的企業票/債券。29.7 投資中未實現損失的相關公允價值爲xx百萬美元，其中包括xx百萬美元的美國政府機構證券投資，xx百萬美元的存單，xx百萬美元的商業票據和xx百萬美元的企業票/債券。1.0 在2024年9月30日之前，未實現損失的投資的總體公允價值中，有$百萬持續處於持有超過12個月的未實現損失位置，剩餘的$65.2 投資中存在未實現虧損的相關公允價值爲xx百萬美元，截至2023年12月31日。165.2 截至2023年12月31日，未實現損失的投資公允價值總額爲xx百萬美元。70.1 截至2023年12月31日，已持續超過12個月的未實現損失的投資公允價值累計xx百萬美元，其餘未實現損失的投資公允價值爲xx百萬美元。95.1 截至2023年12月31日，未實現損失的投資公允價值總額爲xx百萬美元。持續超過12個月的未實現損失的投資公允價值累計xx百萬美元，其餘未實現損失的投資公允價值爲xx百萬美元。
公司回顧了所有處於虧損地位的投資，以及餘下的投資組合，並確定市場情況是導致這些變化的主要因素。在分析未實現虧損頭寸的證券之後，與信貸質量變化有關的這些虧損比例微不足道。公司無意出售這些證券，也不太可能在合同期滿之前被要求出售它們。此外，公司認爲這些證券不會使公司面臨過度的市場風險或交易對手信貸風險。
4. Fair Value Measurements
The Company applies the fair value method under ASC Topic 820, Fair Value Measurements and Disclosures. The ASC Topic 820 hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following categories based on the lowest level input used that is significant to a particular fair value measurement:
•Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities.
•Level 2—Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data.
•Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity—e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security.
The Company had no assets or liabilities that were measured using prices with significant unobservable inputs (Level 3 assets and liabilities) as of September 30, 2024 and December 31, 2023. The carrying value of cash held in money market funds of $225.1 million as of September 30, 2024 and $10.7 million as of December 31, 2023 is included in cash and cash equivalents on the condensed consolidated balance sheets and approximates market value based on quoted market prices or Level 1 inputs. The carrying value of cash held in commercial paper of $6.4 million, corporate bonds of $4.8 million, and U.S. government agency securities of $12.1 million as of September 30, 2024 is included in cash and cash equivalents. The carrying value of cash held in U.S. government agency securities of $2.5 million and certificates of deposit of $60.0 million as of December 31, 2023 is included in cash and cash equivalents.
9
Table of Contents
The fair value measurements of the Company’s cash equivalents and available-for-sale investment securities are identified in the following tables (in thousands):
Fair Value Measurements at
Reporting Date Using
September 30,
2024		Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)		Significant
Other
Observable
Inputs
(Level 2)		Significant
Unobservable
Inputs
(Level 3)
Money Market Funds$225,099 $225,099 $— $— 
U.S. Government Agency Securities135,946 — 135,946 — 
FDIC Certificates of Deposit980 — 980 — 
Certificates of Deposit60,000 — 60,000 — 
Commercial Paper51,699 — 51,699 — 
Corporate Notes/Bonds316,921 — 316,921 — 
$790,645 $225,099 $565,546 $— 
Fair Value Measurements at
Reporting Date Using
December 31,
2023		Quoted Prices
in Active
Markets for
Identical
Assets
(Level 1)		Significant
Other
Observable
Inputs
(Level 2)		Significant
Unobservable
Inputs
(Level 3)
Money Market Funds$10,698 $10,698 $— $— 
U.S. Government Agency Securities150,595 — 150,595 — 
FDIC Certificates of Deposit4,400 — 4,400 — 
Certificates of Deposit60,000 — 60,000 — 
Commercial Paper78,642 — 78,642 — 
Corporate Notes/Bonds119,037 — 119,037 — 
$423,372 $10,698 $412,674 $— 
5. Inventory
Inventory consists of the following (in thousands):
September 30,
2024		December 31,
2023
Raw materials$30,479 $38,621 
Work in process13,048 4,277 
Finished goods10,491 7,370 
Total54,018 50,268 
Less: Current portion(23,539)(11,647)
Total inventory, non-current$30,479 $38,621 
As of September 30, 2024 and December 31, 2023, the Company has recorded $8.0 million and $7.7 million, respectively, in inventory on the condensed consolidated balance sheets which is subject to supplemental regulatory procedures but the Company believes it is probable that such inventory has future economic benefit.
10
Table of Contents
6. Prepaid and Other Assets
Prepaid expenses and other assets consist of the following (in thousands):
September 30,
2024		December 31,
2023
Prepaid operating expenses$31,400 $19,465 
Production campaign deposits30,139 15,127 
Clinical trial advances33,389 11,630 
Prefunded customer programs5,563 3,514 
Total100,491 49,736 
Less: Current portion(94,272)(42,443)
Total other assets$6,219 $7,293 
7. Right of Use Assets and Lease Liabilities
In 2014, the Company entered into a long-term lease with a related party, which, as amended, provided for a lease of useable laboratory and office space located in New York, New York. A member of the Company’s board of directors is the Executive Chairman of the parent company to the landlord under this lease. Concurrent with this lease, the Company entered into a license agreement to occupy certain vivarium-related space in the same facility for the same term and rent escalation provisions as the lease. This license has the primary characteristics of a lease and is characterized as a lease in accordance with ASC Topic 842, Leases, for accounting purposes. In September 2018, the Company further amended the lease to obtain an additional office space beginning October 1, 2018 and to extend the term of the lease for previously acquired space. The lease, as amended, has a term of 14.3 years ending in May 2029. In May 2024, the Company entered into a long-term lease of office space in Bedminster, New Jersey. The lease has a term of 5.7 years ending in February 2030.
The Company has also entered into agreements (the “Vehicle Leases”) with providers (the “Lessors”) to acquire motor vehicles for certain employees. The Vehicle Leases provide for individual vehicle leases, which at each lease commencement was determined to qualify for operating lease treatment. The contractual period of each lease is 12 months, followed by month-to-month renewal periods. The Company estimates the lease term for each vehicle to be 12 months. Leases which the Company determined to have a lease term of 12 months or less will be treated as short-term in accordance with the accounting policy election and are not recognized on the balance sheet. Each lease permits either party to terminate the lease at any time via written notice to the other party. The Company neither acquires ownership of, nor has the option to purchase the vehicles at any time. The Company is required to maintain an irrevocable $1.75 million letter of credit that the related Lessor may draw upon in the event the Company defaults on the related Vehicle Leases, which has been recorded as restricted cash on the condensed consolidated balance sheets.
The following table presents the weighted average remaining lease term, and the weighted average discount rates related to leases as of September 30, 2024 and December 31, 2023:
September 30, 2024December 31, 2023
Other information
Weighted average remaining lease term4.7 years5.3 years
Weighted average discount rate8.82 %9.07 %
11
Table of Contents
The following table presents the lease cost for the nine-month periods ended September 30, 2024 and 2023 (in thousands):
Nine Months Ended September 30,
20242023
Lease cost
Operating lease cost$3,027$2,921
Variable lease cost1,2541,130
Short-term lease cost1,8541,757
$6,135$5,808
Maturity analysis under the lease agreements is as follows (in thousands):
Three months ending December 31, 2024$1,112 
Year ending December 31, 20254,436 
Year ending December 31, 20264,513 
Year ending December 31, 20274,573 
Year ending December 31, 20284,707 
Thereafter2,457 
Total21,798 
Less: Present value discount(4,089)
Total operating lease liability17,709 
Less: Current portion(4,203)
Operating lease liabilities, non-current$13,506 
8. Commitments and Contingencies
License and Royalty Commitments
On May 31, 2005, the Company entered into a worldwide, exclusive License Agreement with Bristol-Myers Squibb Company (“BMS”), pursuant to which the Company holds a license to certain patents and know-how of BMS relating to lumateperone and other specified compounds. The agreement was amended on November 3, 2010. The licensed rights are exclusive, except BMS retains rights in specified compounds in the fields of obesity, diabetes, metabolic syndrome and cardiovascular disease. However, BMS has no right to use, develop or commercialize lumateperone and other specified compounds in any field of use. The Company has the right to grant sublicenses of the rights conveyed by BMS. The Company is obliged under the agreement to use commercially reasonable efforts to develop and commercialize the licensed technology. The Company is also prohibited from engaging in the clinical development or commercialization of specified competitive compounds.
Under the agreement, the Company has made payments of $10.8 million to BMS related to milestones achieved to date for lumateperone. Possible milestone payments remaining total $5.0 million. Under the agreement, the Company may be obliged to make other milestone payments to BMS for each licensed product of up to an aggregate of approximately $14.75 million. The Company is also obliged to make tiered single digit percentage royalty payments ranging between 5 – 9% on sales of licensed products. The Company is obliged to pay to BMS a percentage of non-royalty payments made in consideration of any sublicense.
The agreement extends, and royalties are payable, on a country-by-country and product-by-product basis, through the later of 10 years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product, its method of manufacture or use, or the expiration of other government grants providing market exclusivity, subject to certain rights of the parties to terminate the agreement on the occurrence of certain events. On termination of the agreement, the Company may be obliged to convey to BMS rights in developments relating to a licensed compound or licensed product, including regulatory filings, research results and other intellectual property rights.
12
Table of Contents
Purchase Commitments
The Company enters into certain long-term commitments for goods and services that are outstanding for periods greater than one year. The manufacturing service agreements commit the Company to certain minimum annual purchase commitments for which the Company anticipates making payments within the years 2025 through 2029. As of September 30, 2024, the Company has committed to purchasing production campaigns for various raw materials including active pharmaceutical ingredients (“API”) and its intermediates from each of its supply vendors. The current campaigns are expected to be received into inventory through 2027. Over the course of the vendors’ manufacturing period, the Company will remit payments to each vendor based on the payment plan set forth in their respective agreements. The Company has paid deposits of $30.1 million and $15.1 million as of September 30, 2024 and December 31, 2023, respectively, related to these campaigns. Of the $30.1 million balance as of September 30, 2024, $24.0 million is recorded within prepaid expenses and other current assets as the campaigns are expected to be received within one year of the balance sheet date and $6.1 million is recorded within other assets on the condensed consolidated balance sheet as the campaigns are expected to be received after September 30, 2025. Of the $15.1 million balance as of December 31, 2023, $7.9 million is recorded within prepaid expenses and other current assets and $7.2 million is recorded within other assets on the condensed consolidated balance sheet.
9. Share-Based Compensation
Total share-based compensation expense related to all of the Company's share-based awards, including stock options and restricted stock units (“RSUs”), granted to employees and directors recognized during the three and nine-month periods ended September 30, 2024 and 2023, was comprised of the following (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Inventoriable costs$497 $424 $1,405 $1,186 
Selling, general and administrative11,898 9,564 31,923 25,269 
Research and development5,094 4,323 14,374 11,521 
Total share-based compensation expense$17,489 $14,311 $47,702 $37,976 
Information regarding the stock options activity, including with respect to grants to employees and directors under the Amended and Restated 2018 Equity Incentive Plan (“the Amended 2018 Plan”) and 2019 Inducement Award Plan (“the 2019 Inducement Plan”) as of September 30, 2024, and changes during the nine-month period then ended, are summarized as follows:
Number of
Shares		Weighted-
Average
Exercise
Price		Weighted-
Average
Contractual
Life
Outstanding at December 31, 20234,239,982$28.22 5.2 years
Options granted 202434,539
Options exercised 2024(933,601)
Options canceled or expired 2024(11,460)
Outstanding at September 30, 20243,329,460$30.74 5.2 years
Vested and expected to vest at September 30, 20243,329,460$30.74 
Exercisable at September 30, 20242,968,706$28.00 4.8 years
13
Table of Contents
The fair value of the time-based RSUs is based on the closing price of the Company’s common stock on the date of grant. Information regarding the time-based RSU activity, including with respect to grants to employees under the Amended 2018 Plan and 2019 Inducement Plan, and changes during the nine-month period ended September 30, 2024 is summarized as follows:
Number of
Shares		Weighted-Average
Grant Date
Fair Value Per Share		Weighted-
Average
Contractual
Life
Outstanding at December 31, 20231,645,130$48.92 1.0 years
Time-based RSUs granted in 20241,100,255
Time-based RSUs vested in 2024(732,992)
Time-based RSUs cancelled in 2024(61,611)
Outstanding at September 30, 20241,950,782$60.35 1.2 years
As of September 30, 2024, there were $95.5 million of unrecognized compensation costs estimated related to unvested time-based RSUs.
10. Loss Per Share
The following share-based awards were excluded in the calculation of diluted net loss per common share because their effect could be anti-dilutive as applied to the loss from operations for the three and nine-month periods ended September 30, 2024 and 2023:
Three and Nine Months Ended September 30,
20242023
Stock options3,329,4604,385,555
RSUs2,175,2841,755,460
14
Table of Contents
Item 2.    MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following in conjunction with our unaudited condensed consolidated financial statements and the related notes thereto that appear elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto and under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K filed on February 22, 2024. In addition to historical information, the following discussion and analysis includes forward-looking information that involves risks, uncertainties and assumptions. Our actual results and the timing of events could differ materially from those anticipated by these forward-looking statements as a result of many factors, including those discussed under “Risk Factors” in our Annual Report on Form 10-K filed on February 22, 2024, as updated from time to time in our subsequent periodic and current reports filed with the SEC.
Overview
We are a biopharmaceutical company focused on the discovery, clinical development and commercialization of innovative, small molecule drugs that address underserved medical needs primarily in psychiatric and neurological disorders.
Commercial Product
In December 2019, CAPLYTA® (lumateperone) was approved by the U.S. Food and Drug Administration (FDA), for the treatment of schizophrenia in adults (42 mg/day) and we initiated the commercial launch of CAPLYTA in March 2020. In December 2021, CAPLYTA was approved by the FDA for the treatment of bipolar depression in adults (42 mg/day). We initiated the commercial launch of CAPLYTA for the treatment of bipolar depression in December 2021. Additionally, in April 2022, the FDA approved two additional dosage strengths of CAPLYTA, 10.5 mg and 21 mg capsules, to provide dosage recommendations for patients concomitantly taking strong or moderate CYP3A4 inhibitors, and 21 mg capsules for patients with moderate or severe hepatic impairment (Child-Pugh class B or C). We initiated the commercial launch of these special population doses in August 2022. As used in this report, “CAPLYTA” refers to lumateperone approved by the FDA for the treatment of schizophrenia in adults and for the treatment of bipolar depression in adults, and “lumateperone” refers to, where applicable, CAPLYTA as well as lumateperone for the treatment of indications beyond schizophrenia and bipolar depression.
Clinical and Nonclinical Development Programs
Lumateperone Program
Lumateperone is in Phase 3 clinical development as a novel treatment for major depressive disorder, or MDD. In April 2024 and June 2024, we announced positive topline results from our Phase 3 clinical trials, Study 501 and Study 502, respectively, evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. In both studies, lumateperone 42 mg given once daily as adjunctive therapy to antidepressants met the primary endpoint by demonstrating a statistically significant and clinically meaningful reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score compared to placebo at Week 6. In Study 501, in the modified intent-to-treat (mITT) study population, the least squares (LS) mean reduction from baseline for lumateperone 42 mg was 14.7 points, versus 9.8 points for placebo (LS mean difference = -4.9 points; p<0.0001; ES= 0.61). In Study 502, in the mITT study population, the LS mean reduction from baseline for lumateperone 42 mg was 14.7 points, versus 10.2 points for placebo (LS mean difference= -4.5 points; p<0.0001; ES= 0.56). Lumateperone 42 mg also met the key secondary endpoint in both studies by demonstrating a statistically significant and clinically meaningful reduction in the Clinical Global Impression Scale for Severity of Illness (CGI-S) score compared to placebo at Week 6 (Study 501: p<0.0001; ES= 0.67; Study 502: p<0.0001; ES= 0.51). In Study 501, statistically significant efficacy was seen at the earliest time point tested (Week 1) and maintained throughout the study in both the primary and the key secondary endpoints. In Study 502, numerical improvement versus placebo on the MADRS total score was seen as early as Week 1 and statistically significant efficacy was seen at Week 2 and maintained throughout the study, and statistically significant separation on the CGI-S versus placebo was observed starting at Week 3 and maintained throughout the study. In both Studies 501 and 502, lumateperone 42 mg robustly improved depressive symptoms as reported by patients as measured by the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16) (p<0.0001). Lumateperone was generally safe and well-tolerated in these studies. In the pooled safety data for Studies 501 and 502, the most commonly reported adverse events that were observed at a rate greater than or equal to 5% and greater than twice the rate of placebo in the total population were dizziness (16.6% v. 5.0%), dry mouth (12.6% v. 3.3%), somnolence (12.4% v. 2.3%), nausea (8.5% v. 4.0%) and fatigue (7.7% v. 1.7%).
15
Table of Contents
Adverse events were mostly mild to moderate and resolved within a short period of time. These adverse events were similar to those seen in prior studies of lumateperone as a treatment for bipolar depression and schizophrenia.
We recently completed clinical conduct of our open label roll-over study, Study 503, to assess long-term safety in patients with MDD. We expect to submit a supplemental new drug application, or sNDA, with the FDA for approval of lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD in the fourth quarter of 2024.
We are currently conducting an additional global Phase 3 clinical trial, Study 505, evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. Following our positive results in Studies 501 and 502, we have amended the entry criteria of Study 505 to obtain additional clinical experience with lumateperone in patients who have had an inadequate response to a greater number of antidepressants. The objective of this study is to further expand the large body of evidence supporting lumateperone antidepressant efficacy across different patient populations.
In the first quarter of 2020, as part of our lumateperone bipolar depression clinical program, we initiated our third monotherapy Phase 3 study, Study 403, evaluating lumateperone as monotherapy in the treatment of major depressive episodes associated with bipolar I or bipolar II disorder. Following the positive results in our adjunctive study that was part of our bipolar depression clinical program, Study 402, we amended Study 403 to evaluate major depressive episodes with mixed features in bipolar disorder in patients with bipolar I or bipolar II disorder and mixed features in patients with MDD. In March 2023, we announced positive topline results from Study 403 as lumateperone 42 mg given once daily met the primary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the MADRS total score compared to placebo at Week 6 in the combined patient population of MDD with mixed features and bipolar depression with mixed features (5.7 point reduction vs. placebo; p<0.0001; Cohen’s d effect size (ES) of 0.64). Robust results were also seen in the individual patient population of MDD with mixed features (5.9 point reduction vs. placebo; p<0.0001; ES= 0.67), and in the individual patient population of bipolar depression with mixed features (5.7 point reduction vs. placebo; p<0.0001; ES= 0.64). Additionally, lumateperone 42 mg met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the clinician’s assessment of improvement in the overall severity on the CGI-S score compared to placebo at Week 6 in the combined patient population of MDD with mixed features and bipolar depression with mixed features (p<0.0001; ES= 0.59) and in the individual patient population of MDD with mixed features (p=0.0003; ES= 0.57), as well as the individual patient population of bipolar depression with mixed features (p<0.0001; ES=0.61).
We also have an ongoing study, Study 304, evaluating lumateperone for the prevention of relapse in patients with schizophrenia. The study is being conducted in five phases consisting of a screening phase; a 6-week, open-label run-in phase during which all patients will receive 42 mg of lumateperone per day; a 12-week, open-label stabilization phase during which all patients will receive 42 mg of lumateperone per day; a double-blind treatment phase, 26 weeks in duration, during which patients receive either 42 mg of lumateperone per day or placebo (1:1 ratio); and a 2-week safety follow-up phase. This study is being conducted in accordance with our post approval marketing commitment to the FDA in connection with the approval of CAPLYTA for the treatment of schizophrenia as is typical for antipsychotics. We expect to complete Study 304 and report topline results in the fourth quarter of 2024.
Within the lumateperone portfolio, we have conducted or are in the process of conducting studies with pediatric patients in schizophrenia, bipolar disorder and irritability associated with autism spectrum disorder. Our lumateperone pediatric program includes a double-blind, placebo-controlled study in bipolar depression and two double-blind, placebo-controlled studies in irritability associated with autism spectrum disorder. Additionally, the program includes an open-label safety study in schizophrenia and bipolar disorder. Patient enrollment is ongoing in the open-label safety study as well as in the double-blind, placebo-controlled study in bipolar depression. We expect to begin enrollment in the two double-blind, placebo-controlled studies in irritability associated with autism spectrum disorder in the fourth quarter of 2024. Also, in the second quarter of 2024, we initiated two multicenter, randomized, double-blind, placebo-controlled, Phase 3 studies evaluating lumateperone in adults in the acute treatment of manic or mixed episodes associated with bipolar I disorder (bipolar mania). In addition, we are developing a long-acting injectable, or LAI, formulation to provide more treatment options to patients suffering from mental illness. We have conducted a Phase 1 single ascending dose study with an LAI formulation. This study evaluated the pharmacokinetics, safety and tolerability of a lumateperone LAI in patients with stable symptoms of schizophrenia and was generally safe and well-tolerated. We are evaluating several additional formulations of a lumateperone LAI with treatment durations of one month and longer, and have commenced clinical conduct in a Phase 1 study with additional formulations of our LAI. Given the encouraging efficacy and favorable safety profile to date with oral lumateperone, we believe that an LAI option, in particular, may lend itself to being an important formulation choice for certain patients.
16
Table of Contents
ITI-1284 Program
We are developing ITI-1284-ODT-SL for the treatment of generalized anxiety disorder, psychosis in Alzheimer's disease and agitation in patients with Alzheimer's disease. ITI-1284-ODT-SL is a deuterated form of lumateperone, a new molecular entity formulated as an oral disintegrating tablet for sublingual administration. ITI-1284-ODT-SL is formulated as an oral solid dosage form that dissolves almost instantly when placed under the tongue, allowing for ease of use in the elderly and may be particularly beneficial for patients who have difficulty swallowing conventional tablets. Phase 1 single and multiple ascending dose studies in healthy volunteers and healthy elderly volunteers (> than 65 years of age) evaluated the safety, tolerability and pharmacokinetics of ITI-1284-ODT-SL. In these studies, there were no reported serious adverse events in either age group. In the elderly cohort, reported adverse events were infrequent with the most common adverse event being transient dry mouth (mild). Based on these results, we have initiated Phase 2 programs evaluating ITI-1284-ODT-SL for the treatment of generalized anxiety disorder, psychosis in Alzheimer's disease and agitation in patients with Alzheimer’s disease. The FDA has informed us that they do not believe the deuterated and undeuterated forms of lumateperone are identical. As a result, the non-clinical data from lumateperone may not be broadly applied to ITI-1284-ODT-SL, and we conducted additional toxicology studies. These studies have been completed and patient enrollment is ongoing in our Phase 2 study evaluating ITI-1284-ODT-SL as adjunctive therapy to anti-anxiety medications in patients with generalized anxiety disorder. We expect to initiate patient enrollment in our Phase 2 study evaluating ITI-1284-ODT-SL as monotherapy in patients with generalized anxiety disorder in the fourth quarter of 2024. We have also initiated patient enrollment in a Phase 2 clinical study evaluating ITI-1284-ODT-SL in patients with psychosis associated with Alzheimer’s disease and in a Phase 2 clinical study evaluating ITI-1284-ODT-SL in patients with agitation associated with Alzheimer’s disease. We are continuing with Phase 1 studies with ITI-1284-ODT-SL, including drug-drug interaction studies.
PDE1 Program
We have another major program that has yielded a portfolio of compounds that selectively inhibit the enzyme phosphodiesterase type 1, or PDE1. PDE1 enzymes are highly active in multiple disease states, and our PDE1 inhibitors are designed to reestablish normal function in these disease states. Abnormal PDE1 activity is associated with cellular proliferation and activation of inflammatory cells. Our PDE1 inhibitors ameliorate both of these effects in animal models. We intend to pursue the development of our phosphodiesterase, or PDE, program, for the treatment of aberrant immune system activation in several central nervous system, or CNS, and non-CNS conditions with a focus on diseases where excessive PDE1 activity has been demonstrated and increased inflammation is an important contributor to disease pathogenesis. Our potential disease targets include immune system regulation, neurodegenerative diseases, cancers and other non-CNS disorders. Lenrispodun (ITI-214) is our lead compound in this program. Following the favorable safety and tolerability results in our Phase 1 program, we initiated our development program for lenrispodun for Parkinson’s disease and conducted a Phase 1/2 clinical trial of lenrispodun in patients with Parkinson’s disease to evaluate safety and tolerability in this patient population, as well as motor and non-motor exploratory endpoints. In this study, lenrispodun was generally well-tolerated with a favorable safety profile and clinical signs consistent with improvements in motor symptoms and dyskinesias. Our Phase 2 clinical trial of lenrispodun evaluating improvements in motor symptoms, changes in cognition, and inflammatory biomarkers in patients with Parkinson’s disease is ongoing. We expect to complete this study by the end of 2025. We also have an active Investigational New Drug application, or IND, to evaluate our newest candidate within the PDE1 inhibitor program, ITI-1020, as a novel cancer immunotherapy. Our Phase 1 program with ITI-1020 in healthy volunteers is ongoing.
ITI-333 Program
We also have a development program with our ITI-333 compound as a potential treatment for substance use disorders, pain and psychiatric comorbidities including depression and anxiety. There is a pressing need to develop new drugs to treat opioid addiction and safe, effective, non-addictive treatments to manage pain. ITI-333 is a novel compound that uniquely combines activity as an antagonist at serotonin 5-HT2A receptors and a partial agonist at µ-opioid receptors. These combined actions support the potential utility of ITI-333 in the treatment of opioid use disorder and associated comorbidities (e.g., depression, anxiety, sleep disorders) without opioid-like safety and tolerability concerns. We have conducted a Phase 1 single ascending dose study evaluating the safety, tolerability and pharmacokinetics of ITI-333 in healthy volunteers. In this study, ITI-333 achieved plasma exposures at or above those required for efficacy and was generally safe and well-tolerated. We have an ongoing neuroimaging study to investigate brain occupancy for receptors that play a role in substance use disorder and also have applicability for pain. The results of this study will support the dose selection for future studies. In addition, we completed a multiple ascending dose study with ITI-333 in healthy volunteers. In this study, ITI-333 was generally safe and well-tolerated.
17
Table of Contents
ITI-1500 Program
We also have the ITI-1500 program focused on the development of novel non-hallucinogenic psychedelics, which we refer to as neuroplastogens. Compounds in this series interact with serotonergic (5-HT2a) receptors in a unique way, potentially allowing the development of this new drug class in mood, anxiety and other neuropsychiatric disorders without the liabilities of known psychedelics including the hallucinogenic potential and risk for cardiac valvular pathologies. Our lead compound in this program, ITI-1549, is currently being evaluated in IND enabling studies and is expected to enter human testing in 2025.
Results of Operations
The following discussion summarizes the key factors our management believes are necessary for an understanding of our financial statements.
Revenues
Revenues are comprised primarily of net product sales of our commercial product, CAPLYTA, in the United States. Our net product sales of CAPLYTA represent sales primarily to wholesalers and specialty distributors and reflect certain adjustments deducted from gross product sales to arrive at product sales, net.
Expenses
Our operating expenses are comprised of (i) costs of product sales; (ii) selling expenses; (iii) general and administrative expenses; and (iv) research and development expenses.
Costs of product sales are comprised of:
•royalty payments on product sales;
•direct costs of formulating, manufacturing and packaging drug product; and
•overhead costs consisting of labor, share-based compensation, shipping, external inventory manufacturing and other miscellaneous operating costs.
Selling expenses are incurred in three major categories:
•salaries, share-based compensation, incentives and related benefit costs of a dedicated sales force and commercial organization;
•marketing and promotion expenses; and
•sales operation costs.
General and administrative expenses are incurred in three major categories:
•salaries, share-based compensation and related benefit costs;
•patent, legal and professional costs; and
•office, facilities and infrastructure overhead.
Research and development costs are comprised of:
•fees paid to external parties that provide us with contract services, such as pre-clinical testing, manufacturing and related testing, clinical trial activities and license milestone payments; and
•internal recurring costs, such as costs relating to labor and fringe benefits, share-based compensation, materials, supplies, facilities and maintenance.
18
Table of Contents
The process of researching, developing and commercializing drugs for human use is lengthy, unpredictable and subject to many risks. The costs associated with the commercialization of CAPLYTA and development of our product candidates are substantial, and we have not yet generated sufficient revenue to offset our operating costs. Costs for the clinical development of lumateperone-related projects, including for the treatment of MDD, consume and, together with our required post-marketing studies and other anticipated clinical development programs, will continue to consume a large portion of our current, as well as projected, resources. We intend to pursue other disease indications that lumateperone may address, but there are significant costs associated with pursuing FDA approval for those indications, which would include the cost of additional clinical trials.
A portion of product sold through September 30, 2024 consisted of active pharmaceutical ingredient (API) and drug product that was previously charged to research and development expenses prior to FDA approval of CAPLYTA. Because the Company’s policy does not allow for the capitalization of the cost of drug product that was incurred prior to FDA approval, the cost of drug product sold is lower than it would have been and has a positive impact on our cost of product sales for the three and nine-month periods ended September 30, 2024 and 2023. We expect to continue to have this favorable impact on cost of product sales and related product gross margins until the cost of our sales of CAPLYTA include drug product that is manufactured entirely after the FDA approval. We expect that this will be the case for the remainder of the year and, as a result, our cost of product sales is less than we anticipate it will be in future periods. In addition, as our net product sales increase and we exceed certain sales thresholds, the applicable royalty rate for payments we make under our License Agreement with Bristol Myers Squibb (BMS) increases, which results in an increase to cost of product sales.
We expect that our selling, general and administrative costs will increase from prior periods primarily due to costs associated with our recently completed and future sales force expansions, promotional activities to support the commercial sales of CAPLYTA, as well as costs associated with expanding our infrastructure and anticipated increases in professional fees. During the third quarter of 2024, we expanded our sales force by approximately 150 representatives who will focus on commercial sales of CAPLYTA to primary care physicians. We also expect to further expand our sales force in 2025. We also expect that research and development expenses will increase moderately as we are expanding our clinical trial programs and pre-clinical development activities. We granted significant share-based awards in 2024 and 2023. We expect to continue to grant share-based awards in the future. We expect that our growing employee base will increase our share-based compensation expense in future periods. In addition, inflation has and may continue to affect us by increasing clinical trial, selling, labor and other operational costs.
The following table sets forth our revenues, operating expenses, interest income, income tax expense and net loss for the three and nine-month periods ended September 30, 2024 and 2023 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Revenues
Product sales, net$175,159 $125,810 $481,278 $330,669 
Grant revenue216 363 351 1,602 
Total revenues175,375 126,173 481,629 332,271 
Expenses
Cost of product sales15,304 9,129 36,558 23,043 
Selling, general and administrative132,101 105,207 366,760 305,144 
Research and development66,819 41,550 165,835 129,368 
Total operating expenses214,224 155,886 569,153 457,555 
Loss from operations(38,849)(29,713)(87,524)(125,284)
Interest income12,899 5,498 30,523 14,377 
Income tax expense(374)(43)(790)(188)
Net loss$(26,324)$(24,258)$(57,791)$(111,095)
19
Table of Contents
Comparison of Three and Nine-Month Periods Ended September 30, 2024 and September 30, 2023
Product Sales, Net
Net product sales for the periods presented are comprised of sales of CAPLYTA for the treatment of schizophrenia and bipolar depression. Net product sales were $175.2 million and $481.3 million for the three and nine-month periods ended September 30, 2024 compared to $125.8 million and $330.7 million for the three and nine-month periods ended September 30, 2023, which represents increases of 39% and 46%, respectively. These increases are primarily due to continued growth in sales volume of CAPLYTA for the treatment of schizophrenia and for the treatment of bipolar depression, driven primarily by prescription growth.
Cost of Product Sales
Cost of product sales was $15.3 million and $36.6 million for the three and nine-month periods ended September 30, 2024, compared to $9.1 million and $23.0 million for the three and nine-month periods ended September 30, 2023, which represents increases of 68% and 59%, respectively. Cost of product sales consisted primarily of product royalty fees, direct costs and overhead, all of which increased as a result of the increased sales volume.
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the three-month period ended September 30, 2024 were $132.1 million as compared to $105.2 million in the three-month period ended September 30, 2023, which represents an increase of 26%.
Selling costs were $98.7 million for the three-month period ended September 30, 2024 as compared to selling costs of $80.9 million in the same period in 2023, which represents an increase of 22%. This increase is primarily due to increases of salaries, benefits, and share-based compensation of $11.0 million mainly driven by the primary care sales force expansion that occurred this quarter, professional fees and other costs of $3.4 million and marketing and advertising costs of $3.4 million. Compensation and related benefit costs for our commercial functions for the three-month periods ended September 30, 2024 and 2023 constituted 35% and 35%, respectively, of our selling costs.
General and administrative expenses were $33.4 million for the three-month period ended September 30, 2024 as compared to $24.3 million in the same period in 2023, which represents an increase of 37%. This increase is due to increases in IT related services of $3.8 million, salaries of $3.0 million and professional fees and other costs of $2.3 million. Compensation and related benefit costs for our general and administrative functions for the three-month periods ended September 30, 2024 and 2023 constituted 24% and 18%, respectively, of our general and administrative costs.
Selling, general and administrative expenses for the nine-month period ended September 30, 2024 were $366.8 million as compared to $305.1 million in the nine-month period ended September 30, 2023, which represents an increase of 20%.
Selling costs were $279.3 million for the nine-month period ended September 30, 2024 as compared to selling costs of $233.5 million in the same period in 2023, which represents an increase of 20%. This increase is primarily due to increases of salaries, benefits and share-based compensation of $23.3 million mainly driven by the primary care sales force expansion that occurred this quarter, marketing and advertising costs of $11.2 million, commercialization costs of $9.2 million and professional fees and other costs of $2.1 million. Compensation and related benefit costs for our commercial functions for the nine-month periods ended September 30, 2024 and 2023 constituted 33% and 35%, respectively, of our selling costs.
General and administrative expenses were $87.5 million for the nine-month period ended September 30, 2024 as compared to $71.6 million in the same period in 2023, which represents an increase of 22%. This increase is due to increases in IT related services of $9.0 million, salaries of $4.7 million and professional fees and other costs of $2.2 million. Compensation and related benefit costs for our general and administrative functions for the nine-month periods ended September 30, 2024 and 2023 constituted 24% and 22%, respectively, of our general and administrative costs.
20
Table of Contents
Research and Development Expenses
The following tables set forth our research and development expenses for the three and nine-month periods ended September 30, 2024 and 2023 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
External service costs$53,188 $29,123 $126,029 $94,579 
Internal and other costs13,631 12,427 39,806 34,789 
Total research and development expenses$66,819 $41,550 $165,835 $129,368 
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Lumateperone costs$40,605 $23,149 $100,328 $78,510 
Non-lumateperone costs16,383 9,614 37,859 27,670 
Overhead and other costs9,831 8,787 27,648 23,188 
Total research and development expenses$66,819 $41,550 $165,835 $129,368 
Research and development expenses were $66.8 million for the three-month period ended September 30, 2024 as compared to $41.6 million in the same period in 2023, which represents an increase of 61%. This increase is due primarily to increases of $17.4 million for lumateperone costs, $6.8 million for non-lumateperone costs and $1.0 million for overhead and other costs. External service costs increased by $24.0 million for the period due to the increased number of clinical trials for lumateperone and non-lumateperone projects. Internal and other costs increased by $1.2 million for the period due primarily to labor related costs and share-based compensation.
Research and development expenses were $165.8 million for the nine-month period ended September 30, 2024 as compared to $129.4 million in the same period in 2023, which represents an increase of 28%. This increase is due primarily to increases of $21.8 million for lumateperone costs, $10.2 million for non-lumateperone costs and $4.4 million for overhead and other costs. External service costs increased by $31.4 million for the period due to the increased number of clinical trials for lumateperone and non-lumateperone projects. Internal and other costs increased by $5.0 million for the period due primarily to labor related costs and share-based compensation.
Liquidity and Capital Resources

Sources of Liquidity
To date, we have funded our operations through proceeds from public and private offerings of our common stock and other securities, as well as collections from net product revenue related to the sales of CAPLYTA. As of September 30, 2024, our cash and cash equivalents, investment securities, and restricted cash totaled approximately $1.0 billion, which we believe, along with cash generated from ongoing operations, will enable us to fund our operating expenses and capital expenditure requirements for at least the foreseeable future from the filing date of this report. During that time, we expect to have increased net product revenue as well as increases in our operating expenses.
We balance the level of cash, cash equivalents and investments on hand with our projected needs. We then assess the availability of funding on favorable terms with minimal risk. Subject to market conditions, interest rates, results of our clinical trials, progress of our commercialization efforts and other factors, we may pursue opportunities to obtain additional financing in the future, which could include public or private sales of our equity securities, sales of debt securities, incurrence of debt from commercial lenders, strategic collaborations, and licensing a portion or all of our product candidates and technology. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third-party funding, marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.
21
Table of Contents
Our cash, cash equivalents, and investments are maintained in checking accounts, money market accounts, money market funds, U.S. government agency securities, certificates of deposit, commercial paper, corporate notes and corporate bonds at major financial institutions. Our aim is to minimize the potential effects of concentration and degrees of risk. Although we maintain cash balances and investments with financial institutions in excess of insured limits, we do not anticipate any losses with respect to such balances because these financial institutions are highly-rated institutions and custodians of our investments.

Cash Flows

The following table summarizes our cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):

Nine Months Ended September 30,
20242023Change
Net cash used in operating activities$(60,099)$(122,138)$62,039 
Net cash (used in) provided by investing activities(185,258)58,119 (243,377)
Net cash provided by financing activities561,902 14,806 547,096 
Net increase (decrease) in cash, cash equivalents, and restricted cash$316,545 $(49,213)$365,758 
Net cash used in operating activities totaled $60.1 million for the nine months ended September 30, 2024 compared to $122.1 million of net cash used in operating activities for the nine months ended September 30, 2023. This decrease in cash used in operations primarily resulted from an increase in our net product sales.
Net cash used in investing activities totaled $185.3 million for the nine months ended September 30, 2024 compared to $58.1 million of cash provided by investing activities for the nine months ended September 30, 2023. The increase in net cash used in investing activities was primarily due to an increase in purchases of investment securities.
Net cash provided by financing activities totaled $561.9 million for the nine months ended September 30, 2024 compared to $14.8 million of cash provided by financing activities for the nine months ended September 30, 2023. This increase in net cash provided by financing activities was attributable primarily to the completion of an underwritten public offering of shares of our common stock in April 2024 resulting in net proceeds of approximately $543.1 million, after deducting underwriting discounts and commissions and offering expenses.

Operational and Capital Funding Requirements
Our cash requirements in the short and long term consist of operational, manufacturing, and capital expenditures, a portion of which contain contractual or other obligations. Our material long-term contractual commitments are comprised of licensing and royalty commitments with BMS, operating leases for our office and laboratory spaces, and purchase obligations supporting our commercial and R&D operations. Refer to our discussion of Liquidity and Capital Resources in “Part II, Item 7 — Management’s Discussion and Analysis of Financial Condition and Results of Operations,” of our Annual Report on Form 10-K for the year ended December 31, 2023, and Note 7, Right of Use Assets and Lease Liabilities, and Note 8, Commitments and Contingencies, in the Notes to the Condensed Consolidated Financial Statements in Part I, Item 1, Financial Statements, of this Quarterly Report on Form 10-Q for the discussion of our contractual commitments.
Critical Accounting Policies and Estimates
Our critical accounting policies are those policies which require the most significant judgments and estimates in the preparation of our condensed consolidated financial statements. We evaluate our estimates, judgments, and assumptions on an ongoing basis. Actual results may differ from these estimates under different assumptions or conditions. A summary of our critical accounting policies is presented in Part II, Item 7, of our Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes to our critical accounting policies during the nine-month period ended September 30, 2024.
22
Table of Contents
The discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires management to make estimates and assumptions that affect reported amounts of assets and liabilities as of the date of the balance sheet and reported amounts of revenues and expenses for the periods presented. Judgments must also be made about the disclosure of contingent liabilities. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates and under different assumptions or conditions.
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, requiring public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are also required to apply the disclosure requirements. The standard is effective for annual reporting periods beginning after December 15, 2023, and for interim reporting periods beginning January 1, 2025, with early adoption permitted. We are currently evaluating the potential impact that this new standard will have on our consolidated financial statements and related disclosures.
Certain Factors That May Affect Future Results of Operations
The SEC encourages companies to disclose forward-looking information so that investors can better understand a company’s future prospects and make informed investment decisions. This Quarterly Report on Form 10-Q contains such “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and other important factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about: our estimates regarding expenses, revenues, uses of cash, cash equivalents and investment securities, capital requirements and the need for additional financing; our expectations regarding our commercialization of CAPLYTA; the supply and availability of and demand for our product; our recently completed and future sales force expansions; the initiation, cost, timing, progress and results of our development activities, non-clinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approval, or submit an application for regulatory approval, of lumateperone and our other existing product candidates, any product candidates that we may develop, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; our plans to research, develop and commercialize lumateperone and our other current and future product candidates; the election by any collaborator to pursue research, development and commercialization activities; our ability to obtain future reimbursement and/or milestone payments from our collaborators; our ability to attract collaborators with development, regulatory and commercialization expertise; our ability to obtain and maintain intellectual property protection for our product candidates, including through our litigation against the ANDA Filers; our ability to successfully commercialize lumateperone and our other product candidates; the performance of our third-party suppliers and manufacturers and our ability to obtain alternative sources of raw materials; our ability to obtain additional financing; our use of the proceeds from our securities offerings; our exposure to investment risk, interest rate risk, inflation risk, capital market risk, foreign currency fluctuations and geopolitical instability; and our ability to attract and retain key scientific, management, or sales and marketing personnel.
23
Table of Contents
Words such as “may,” “anticipate,” “estimate,” “expect,” “may,” “project,” “intend,” “plan,” “believe,” “potential,” “predict,” “project,” “likely,” “will,” “would,” “could,” “should,” “continue” and words and terms of similar substance used in connection with any discussion of future operating or financial performance, identify forward-looking statements. All forward-looking statements are management’s present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described in the forward-looking 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 payers; 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; there is no guarantee that our planned sNDA for the treatment of MDD will be submitted or approved, if at all, on the timeline that we expect; 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, commercialization, manufacturing or supply of our product and product candidates; risks related to changes in interest rates, high rates of inflation, global supply chain disruptions, and geopolitical instability on our business; disruptions resulting from the impact of public health pandemics or epidemics (including, for example, the COVID-19 pandemic), the conflicts in the Ukraine, Russia or the Middle East, man-made or natural disasters, global economic uncertainty, market disruptions, cybersecurity incidents or other causes; and the other risk factors detailed under the heading “Risk Factors” in our most recent Annual Report on Form 10-K, as updated under the heading “Risk Factors” from time to time in our subsequent periodic and current reports filed with the SEC.
In light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained in this Quarterly Report on Form 10-Q or in any document incorporated by reference might not occur. Stockholders are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise. All subsequent forward-looking statements attributable to the Company or to any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section.
Item 3.    QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Sensitivity. As of September 30, 2024, we had cash, cash equivalents, investment securities and restricted cash of approximately $1.0 billion, consisting of cash deposited in highly rated financial institutions in the United States and in short-term U.S. Treasury bonds, money market funds, as well as high-grade corporate bonds and commercial paper. The primary objective of our investment activities is to preserve our capital for the purpose of funding operations and we do not enter into investments for trading or speculative purposes. We believe that we do not have material exposure to high-risk investments such as mortgage-backed securities, auction rate securities or other special investment vehicles within our money-market fund investments. We believe that we do not have any material exposure to changes in fair value as a result of changes in interest rates as we intend and have the ability to hold our investments to maturity. During the third quarter of 2024, there was an unrealized gain due to a decline in interest rates that resulted in a net unrealized gain position of $1.6 million as of September 30, 2024.
Inflation Risk. Inflation generally affects us by increasing our cost of labor, clinical trial costs, and other outsourced activities. To date, inflation has not had a material impact on our business. Should global inflation increase in the future, we expect increases in clinical trial, selling, labor, and other operating costs. If our costs were to become subject to significant inflationary pressures, we may not be able to fully offset such higher costs through price increases of our product. Our inability or failure to do so could adversely affect our business, financial condition and results of operations.
24
Table of Contents
Capital Market Risk. Although we receive product revenues from commercial sales of CAPLYTA, we may in the future raise funds through other sources. One possible source of funding is through further securities offerings. Our ability to raise funds in this manner depends upon capital market forces affecting our stock price among other things.
Foreign Currency Risk. Due to our operations outside of the United States, we are exposed to market risk related to changes in foreign currency exchange rates. Historically, our foreign currency exposure has been limited so we have not hedged for this exposure. Changes in the relative values of currencies occur regularly and, in some instances, could materially adversely affect our business, our results of operations or our cash flows. For the nine-month periods ended September 30, 2024 and 2023, changes in foreign currency exchange rates did not have a material impact on our historical financial position, our business, our financial condition, our results of operations or our cash flows.
Item 4.    CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures. Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act) as of the end of the period covered by this Form 10-Q, have concluded that, based on such evaluation, our disclosure controls and procedures were effective at a reasonable assurance level to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure.
(b) Changes in Internal Controls. There were no changes in our internal control over financial reporting identified in connection with the evaluation of such internal control that occurred during the three-month period ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
25
Table of Contents
PART II: OTHER INFORMATION
Item 1.    LEGAL PROCEEDINGS
As previously disclosed, in February 2024, we received notices from Alkem Laboratories Ltd., Aurobindo Pharma USA, Inc. and Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Inc. (on behalf of Dr. Reddy’s Laboratories Ltd.), MSN Laboratories Private Ltd., Sandoz Inc., Hetero USA, Inc. (the U.S. Regulatory Agent for Hetero Labs Limited Unit - V, a division of Hetero Labs Limited) and Zydus Pharmaceuticals (USA), Inc., which we refer to as ANDA Filers, that each company had filed an abbreviated new drug application, or ANDA, with the FDA seeking approval of generic version of CAPLYTA. The ANDAs each contained Paragraph IV Patent Certifications alleging that certain of our patents covering CAPLYTA are invalid and/or will not be infringed by each ANDA Filer’s manufacture, use or sale of the medicine for which the ANDA was submitted.
Under the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, or the FDCA, we had 45 days from receipt of the notice letters to commence patent infringement lawsuits against these generic drug manufacturers in a federal district court to trigger a stay precluding the FDA’s approval of any ANDA from being effective any earlier than 7.5 years from the date of approval of the CAPLYTA new drug application or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first. After conducting the necessary due diligence, and within the 45 day period required under the FDCA, we filed lawsuits on March 27, 2024 and March 28, 2024 in the U.S. District Court for the District of New Jersey against each of the seven generic drug manufacturers who notified us of their ANDA filings. Our lawsuits seek a declaratory judgment that our patents have been infringed by the respective ANDA Filer, an order that any FDA approval of the ANDA Filer's product be not earlier than the date of the expiration of our applicable patents, injunctions against the commercialization of the ANDA Filer's product prior to such expiration date, and an award for attorneys' fees, costs and expenses. In the ANDA Filers’ respective answers to our complaints filed in May, June and July 2024, five of the ANDA Filers asserted counterclaims against us seeking a declaratory judgment of noninfringement and invalidity of our patents.
On July 16, 2024, the U.S. District Court for the District of New Jersey issued an order consolidating the cases described above for all pretrial purposes. A scheduling conference for the consolidated cases was held on July 29, 2024 and on August 8, 2024, the U.S. District Court for the District of New Jersey issued a scheduling order that set the date for the bench trial to begin on October 27, 2026.
In July and August 2024, we received an additional notice from each of (i) Dr. Reddy’s Laboratories Inc. and Dr. Reddy’s Laboratories Ltd., and (ii) Alkem Laboratories Ltd., respectively, each of which is an ANDA Filer, that such ANDA Filer had filed an additional Paragraph IV Patent Certification alleging that an additional patent covering CAPLYTA is invalid and/or will not be infringed by such ANDA Filer’s manufacture, use or sale of the medicine for which the ANDA was submitted. On August 29, 2024, we filed additional lawsuits in the U.S. District Court for the District of New Jersey against each of the seven ANDA Filers with respect to two additional patents covering CAPLYTA (including the patent referenced in the July and August ANDA Filer notices) seeking a declaratory judgment that our patents have been infringed by the respective ANDA Filer, an order that any FDA approval of the ANDA Filer’s product be not earlier than the date of expiration of our applicable patents, injunctions against the commercialization of the ANDA Filer’s product prior to such expiration date, and an award for attorneys’ fees, costs and expenses. In the ANDA Filers’ respective answers to these complaints filed up to the date of this report, two of the ANDA Filers asserted counterclaims against us seeking a declaratory judgment of noninfringement and invalidity of our patents. On October 15, 2024, the U.S. District Court for the District of New Jersey issued an order consolidating these additional cases with the consolidated case described above for all pretrial purposes.
While we intend to vigorously defend and enforce our intellectual property rights protecting CAPLYTA, we can offer no assurance as to when the lawsuits will be decided, whether the lawsuits will be successful, or that a generic equivalent of CAPLYTA will not be approved and enter the market before the expiration of our patents.
Item 1A. RISK FACTORS
There have been no material changes to the risk factors discussed in Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 22, 2024.
26
Table of Contents
Item 2.    UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Unregistered Sales of Equity Securities
Not applicable.
Issuer Purchases of Equity Securities
We did not repurchase any of our equity securities during the quarter ended September 30, 2024.
Item 3.    DEFAULTS UPON SENIOR SECURITIES
Not applicable.
Item 4.    MINE SAFETY DISCLOSURES
Not applicable.
Item 5.    OTHER INFORMATION

During the fiscal quarter ended September 30, 2024, the following director and executive officers adopted a "Rule 10b5-1 trading arrangement" (as defined in Item 408 of Regulation S-K of the Exchange Act):
•On August 13, 2024, Michael I. Halstead, President, adopted a Rule 10b5-1 Sales Plan having an end date of December 31, 2024. The plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) and provides for the sale of up to an aggregate of 41,583 shares of our common stock upon the exercise of stock options. On August 13, 2024, Mr. Halstead adopted a subsequently commencing Rule 10b5-1 Sales Plan with a start date of January 2, 2025 and an end date of April 10, 2025. The plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) and provides for the sale of (i) an aggregate of 32,717 shares of our common stock upon the vesting of restricted stock units and (ii) an indeterminate number of shares of our common stock sufficient to cover Mr. Halstead’s tax liability upon the vesting of performance restricted stock units for up to 11,017 shares of our common stock at maximum achievement of the performance vesting conditions.
•On September 3, 2024, Sharon Mates, Ph.D., Chairman and Chief Executive Officer, adopted a Rule 10b5-1 Sales Plan having an end date of December 16, 2024. The plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) and provides for the sale of up to an aggregate of 102,697 shares of our common stock upon the exercise of stock options.

There were no other “Rule 10b5-1 trading arrangements” or "non-Rule 10b5-1 trading arrangements" (as each term is defined in Item 408 of Regulation S-K of the Exchange Act) adopted, modified or terminated during the fiscal quarter ended September 30, 2024 by our directors and executive officers.
27
Table of Contents
Item 6.    EXHIBITS
Exhibit
Number
Exhibit Description
Filed
Herewith
Incorporated by
Reference herein
from Form
or Schedule
Filing Date
SEC File/
Reg. Number
10.18-K
(Exhibit 10.1)		8/7/2024
001-36274
10.2
8-K
(Exhibit 10.2)
8/7/2024
001-36274
10.3
8-K
(Exhibit 10.3)
8/7/2024
001-36274
10.4
8-K
(Exhibit 10.4)
8/7/2024
001-36274
10.5
8-K
(Exhibit 10.5)
8/7/2024
001-36274
10.6
X
10.7
X
31.1X
31.2X
32X
28
Table of Contents
101
The following materials from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, formatted in Inline XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets as of September 30, 2024 (unaudited) and December 31, 2023, (ii) Condensed Consolidated Statements of Operations (unaudited) for the three and nine months ended September 30, 2024 and 2023, (iii) Condensed Consolidated Statements of Comprehensive Loss (unaudited) for the three and nine months ended September 30, 2024 and 2023, (iv) Condensed Consolidated Statements of Stockholders’ Equity (unaudited) for the three and nine months ended September 30, 2024 and 2023, (v) Condensed Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2024 and 2023, and (vi) Notes to Condensed Consolidated Financial Statements (unaudited).
X
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).X

*     Management contract or compensatory plan or arrangement.
29
Table of Contents
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
INTRA-CELLULAR THERAPIES, INC.
Date: October 30, 2024
By:/s/ Sharon Mates, Ph.D.
Sharon Mates, Ph.D.
Chairman and Chief Executive Officer
Date: October 30, 2024
By:
/s/ Sanjeev Narula
Sanjeev Narula
Executive Vice President, Chief Financial Officer and Treasurer
30