Private company
Intra-Cellular Therapies, Inc.
In its 2025 annual report the company says: “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.”4 It is headquartered in New York, United States.2
Last updated Oct 20, 2026.
Overview
- IndustryPharmaceutical Preparations2
- HeadquartersNew York, United States2
- Incorporated inDE3
- Business address135 Route 202/206, Suite 6, Bedminster, Nj 079213
- Filer categoryLarge accelerated filer3
- Legal formCorporation2
- LEI5299002U2KGF193IJA202
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressc/o CORPORATION SERVICE COMPANY, 251 LITTLE FALLS DRIVE, 19808 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 53916142
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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.4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2024
Where the money goes
Where each dollar of revenue went, fiscal 2024
- Research and development32¢$236.1M
- Selling, general and admin68¢$504.5M
- Income tax0¢$473.0K
Out of $680.9M in revenue.5 The company lost money this year.
Financial statements
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Revenue | $60.6K6 | $22.8M7 | $83.8M8 | $250.3M5 | $464.4M5 | $680.9M5 | |
| Research and development | $132.2M9 | $89.1M6 | $65.8M7 | $88.8M8 | $134.7M5 | $180.1M5 | $236.1M5 |
| Selling, general and admin | $358.8M5 | $409.9M5 | $504.5M5 | ||||
| Operating expenses | $369.5M8 | $513.9M5 | $623.8M5 | $797.6M5 | |||
| Operating income | -$162.3M9 | -$154.0M6 | -$231.2M7 | -$285.7M8 | -$263.6M5 | -$159.4M5 | -$116.7M5 |
| Interest | |||||||
| Income before tax | -$284.1M8 | -$256.2M5 | -$139.0M5 | -$74.2M5 | |||
| Income tax | $1.6K9 | $1.6K6 | $14.0K7 | $6.0K8 | $6.0K5 | $636.0K5 | $473.0K5 |
| Net income | -$155.1M9 | -$147.7M6 | -$227.0M7 | -$284.1M8 | -$256.3M5 | -$139.7M5 | -$74.7M5 |
| Earnings per share | -$3.237 | -$3.508 | -$2.725 | -$1.465 | -$0.725 | ||
| Earnings per share (diluted) | -$3.237 | -$3.508 | -$2.725 | -$1.465 | -$0.725 | ||
| Shares (weighted, basic) | 81.3M shares8 | 94.0M shares5 | 95.9M shares5 | 103.1M shares5 | |||
| Shares (weighted, diluted) | 81.3M shares8 | 94.0M shares5 | 95.9M shares5 | 103.1M shares5 |
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash | $54.9M9 | $107.6M6 | $60.0M7 | $92.4M8 | $148.6M5 | $147.8M5 | $306.9M5 |
| Receivables | $20.2M7 | $75.2M8 | $114.0M5 | $166.5M5 | |||
| Inventory | $7.9M7 | $23.9M8 | $11.6M5 | $26.3M5 | |||
| Current assets | $355.4M12 | $230.3M9 | $690.9M6 | $467.3M7 | $738.0M8 | $667.8M5 | $1.3B5 |
| Property, plant and equipment | $1.8M7 | $1.9M8 | $1.7M5 | $1.5M5 | |||
| Total assets | $357.2M12 | $251.2M9 | $717.3M6 | $489.9M7 | $754.8M8 | $728.3M5 | $1.4B5 |
| Accounts payable | $8.7M7 | $10.4M8 | $11.5M5 | $26.1M5 | |||
| Current liabilities | $36.3M12 | $36.2M9 | $36.9M6 | $53.4M7 | $83.2M8 | $123.5M5 | $205.7M5 |
| Total liabilities | $39.5M12 | $56.2M9 | $60.5M6 | $72.0M7 | $98.7M8 | $136.9M5 | $218.5M5 |
| Retained earnings | -$1.2B7 | -$1.5B8 | -$1.6B5 | -$1.7B5 | |||
| Shareholders’ equity | $317.7M6 | $195.0M7 | $656.9M8 | $417.9M5 | $656.1M5 | $591.4M5 | $1.1B5 |
| Shares outstanding | 54.9M shares12 | 55.5M shares9 | 80.5M shares6 | 81.9M shares7 | 94.8M shares8 | 96.4M shares5 | 106.2M shares5 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash from operations | -$118.2M9 | -$128.0M6 | -$230.1M7 | -$259.5M8 | -$270.2M5 | -$124.2M5 | -$73.2M5 |
| Stock-based compensation | $34.3M8 | $43.0M5 | $52.8M5 | $64.0M5 | |||
| Capital spending | $391.3K9 | $700.4K6 | $267.0K7 | $325.0K8 | $778.0K5 | $269.0K5 | $322.0K5 |
| Free cash flow | -$118.6M | -$128.7M | -$230.3M | -$259.9M | -$271.0M | -$124.5M | -$73.5M |
| Cash from investing | $280.3M8 | -$128.4M5 | $105.5M5 | -$335.1M5 | |||
| Cash from financing | $11.5M8 | $455.2M5 | $17.8M5 | $567.5M5 |
Corporate structure
Intra-Cellular Therapies, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Intra-Cellular Therapies, Inc.
- JPMorgan Chase Filed SCHEDULE 13G/A on Intra-Cellular Therapies, Inc., latest Jun 5, 2025 (2 filings since Oct 10, 2024)
- FMR LLC Filed SCHEDULE 13G/A on Intra-Cellular Therapies, Inc., latest Feb 7, 2025 (5 filings since Feb 9, 2022)
- BlackRock Filed SC 13G/A on Intra-Cellular Therapies, Inc., latest Nov 8, 2024 (2 filings since Oct 24, 2024)
- VANGUARD GROUP INC Filed SC 13G/A on Intra-Cellular Therapies, Inc., latest Feb 13, 2024 (3 filings since Feb 10, 2022)
- WASATCH ADVISORS LP Filed SC 13G/A on Intra-Cellular Therapies, Inc., latest Feb 9, 2024 (4 filings since Dec 2, 2021)
- Wellington Management Company Filed SC 13G/A on Intra-Cellular Therapies, Inc., latest Feb 8, 2024 (2 filings since Feb 6, 2023)
- Intra-Cellular Therapies, Inc. New York, New York, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Intra-Cellular Therapies, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, net | $1.5M5 Dec 31, 2024 | $1.7M5 Dec 31, 2023 | −11.2% |
| Operating-lease assets (leased space) | $13.4M5 Dec 31, 2024 | $12.9M5 Dec 31, 2023 | +3.9% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $306.9M5 Dec 31, 2024 | $147.8M5 Dec 31, 2023 | +107.7% |
| Marketable securities, current | $694.1M5 Dec 31, 2024 | $350.2M5 Dec 31, 2023 | +98.2% |
| Marketable securities, non-current | $186.0M5 Dec 31, 2024 | $77.8M5 Dec 31, 2023 | +139.1% |
| Debt securities available for sale | $694.1M5 Dec 31, 2024 | $412.7M5 Dec 31, 2023 | +68.2% |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $26.3M5 Dec 31, 2024 | $11.6M5 Dec 31, 2023 | +125.7% |
| Raw materials | $38.9M5 Dec 31, 2024 | $38.6M5 Dec 31, 2023 | +0.7% |
| Work in process | $15.0M5 Dec 31, 2024 | $4.3M5 Dec 31, 2023 | +250.0% |
| Finished goods | $11.3M5 Dec 31, 2024 | $7.4M5 Dec 31, 2023 | +53.5% |
Properties, in its own words
Our headquarters are located at 135 Route 202/206, Suite 6, Bedminster, NJ 07921, where we occupy approximately 27,700 square feet of office space. The term of the lease expires in January 2030. We also lease approximately 32,000 square feet of office and laboratory space in New York, New York as well as 4,000 square feet of office space in Towson, Maryland. The term of these leases expires in March 2029 and August 2026, respectively. In addition, we sublease to a third party approximately 6,400 square feet of the office space that we lease in New York, New York described above under a sublease that expires in March 2026, subject to extension.
Item 2 of the 10-K filed Feb 21, 2025.4
Leadership
Who has led Intra-Cellular Therapies, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
- Chief executive officerSamir Naji Masri Apr 9, 2013 to Apr 9, 201313
- Chief executive officerSharon Mates Sep 9, 2013 to Apr 2, 202514
- ChairSharon Mates Sep 9, 2013 to Apr 2, 202514
- PresidentMichael Halstead Nov 14, 2024 to Apr 2, 202515
- PresidentSharon Mates Sep 9, 2013 to Mar 11, 202414
- Chief financial officerSanjeev Narula Aug 14, 2024 to Apr 2, 202516
- Chief financial officerSamir Naji Masri Apr 9, 2013 to Apr 9, 201313
- Chief financial officerLawrence J. Hineline Sep 9, 2013 to Mar 11, 202417
Board members and other officers (15)
- Chief Medical OfficerSuresh K. Durgam Oct 28, 2020 to Apr 2, 202518
- EVP, Chief Commercial OfficerMark Neumann Oct 17, 2018 to Apr 2, 202519
- EVP and Chief Medical OfficerAndrew Satlin Nov 15, 2017 to Feb 20, 202020
- VP, Corp. Communications & IRJuan F. Sanchez Mar 13, 2014 to Jan 6, 201521
- VP of Business DevelopmentAllen A. Fienberg Sep 9, 2013 to Sep 11, 201522
- VP, Clinical DevelopmentKimberly E. Vanover Sep 9, 2013 to Jan 8, 201923
- Vice President, Drug DiscoveryLawrence P. Wennogle Sep 9, 2013 to Jun 9, 201524
- Board memberEduardo Rene Salas Apr 21, 2022 to Apr 2, 202525
- Board memberNostrand Robert L. Van Jan 14, 2014 to Apr 2, 202526
- Board memberSamir Naji Masri Apr 9, 2013 to Apr 9, 201313
- Board memberChristopher D. Alafi Sep 9, 2013 to May 28, 202127
- Board memberMichael Rawlins Sep 9, 2013 to Jun 13, 202228
- Board memberRichard A. Lerner Sep 9, 2013 to Oct 4, 202129
- Board memberJoel S. Marcus Sep 18, 2013 to Apr 2, 202530
- General counselMichael Halstead Jul 31, 2014 to Mar 11, 202431
Former names
- Oneida Resources Corp.Feb 8, 2013 to Aug 29, 20133
Timeline
- Apr 2, 20258-K Completed an acquisition or sale; Listing notice or transfer; Change to shareholders' rights32
- Mar 27, 20258-K Shareholder vote33
- Mar 18, 20258-K Other events34
- Mar 3, 20258-K Other events35
- Feb 21, 20258-K Results of operations; Other events36
- Jan 13, 20258-K Entered a material agreement; Regulation FD disclosure37
- Jan 10, 20258-K Other events38
- Dec 3, 20248-K Other events39
- Nov 5, 20248-K Other events40
- Oct 30, 20248-K Results of operations; Other events41
- Aug 7, 20248-K Results of operations; Executive or director change; Regulation FD disclosure42
- Jun 18, 20248-K Other events43
- Sep 9, 2013New chief executive Sharon Mates becomes CEO14
- Apr 9, 2013New chief executive Samir Naji Masri becomes CEO13
Calendar
When it reported results
- Feb 21, 2025Reported quarterly or annual results36
- Oct 30, 2024Reported quarterly or annual results41
- Aug 7, 2024Reported quarterly or annual results42
- May 7, 2024Reported quarterly or annual results44
- Apr 16, 2024Reported quarterly or annual results45
- Feb 22, 2024Reported quarterly or annual results46
- Nov 2, 2023Reported quarterly or annual results47
- Aug 3, 2023Reported quarterly or annual results48
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
346 filings to the SEC since October 2021: 5 annual reports, 10 quarterly reports, 44 major events, 183 insider forms, 18 large holders, 86 other. The latest 20:
- Jun 5, 2025SCHEDULE 13G/A EDGAR
- Apr 14, 202515-12G EDGAR
- Apr 9, 2025EFFECT EDGAR
- Apr 2, 2025POSASR EDGAR
- Apr 2, 2025S-8 POS EDGAR
- Apr 2, 2025S-8 POS EDGAR
- Apr 2, 2025S-8 POS EDGAR
- Apr 2, 2025S-8 POS EDGAR
- Apr 2, 2025S-8 POS EDGAR
- Apr 2, 2025S-8 POS EDGAR
- Apr 2, 2025POS AM EDGAR
- Apr 2, 20258-K EDGAR
- Apr 2, 20254 EDGAR
- Apr 2, 20254 EDGAR
- Apr 2, 20254 EDGAR
- Apr 2, 20254 EDGAR
- Apr 2, 20254 EDGAR
- Apr 2, 20254 EDGAR
- Apr 2, 20254 EDGAR
- Apr 2, 20254 EDGAR
The 346 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
111 open-market trades by officers, directors and large owners since October 2021: 0 buys and 111 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Dec 5, 2024 | Mates SharonChairman and CEO | Sale | 51,697 | $84.08 | $4.3M | Form 4 |
| Dec 4, 2024 | Mates SharonChairman and CEO | Sale | 51,000 | $85.79 | $4.4M | Form 4 |
| Nov 13, 2024 | Halstead MichaelPresident | Sale | 18,714 | $88.38 | $1.7M | Form 4 |
| Nov 12, 2024 | Halstead MichaelPresident | Sale | 22,869 | $89.12 | $2.0M | Form 4 |
| Aug 30, 2024 | Mates SharonChairman and CEO | Sale | 34,396 | $72.84 | $2.5M | Form 4 |
| Aug 29, 2024 | Mates SharonChairman and CEO | Sale | 35,604 | $72.57 | $2.6M | Form 4 |
| Aug 28, 2024 | Mates SharonChairman and CEO | Sale | 32,699 | $72.75 | $2.4M | Form 4 |
| Aug 27, 2024 | Mates SharonChairman and CEO | Sale | 40,513 | $73.58 | $3.0M | Form 4 |
| Aug 26, 2024 | Mates SharonChairman and CEO | Sale | 22,713 | $74.59 | $1.7M | Form 4 |
| Aug 23, 2024 | Mates SharonChairman and CEO | Sale | 28,680 | $74.46 | $2.1M | Form 4 |
| Aug 22, 2024 | Mates SharonChairman and CEO | Sale | 39,380 | $74.68 | $2.9M | Form 4 |
| Aug 21, 2024 | Mates SharonChairman and CEO | Sale | 53,013 | $75.65 | $4.0M | Form 4 |
| Aug 16, 2024 | Neumann MarkEVP, Chief Commercial Officer | Sale | 18,714 | $75.08 | $1.4M | Form 4 |
| Jun 24, 2024 | RIGGS RORY BDirector | Sale | 4,462 | $75.57 | $337.2K | Form 4 |
| Jun 18, 2024 | VAN NOSTRAND ROBERT LDirector | Sale | 20,000 | $75.91 | $1.5M | Form 4 |
| Mar 11, 2024 | Mates SharonChairman and CEO | Sale | 20,565 | $65.21 | $1.3M | Form 4 |
| Mar 11, 2024 | Hineline Lawrence J.SVP of Finance, CFO | Sale | 10,121 | $65.96 | $667.6K | Form 4 |
| Mar 11, 2024 | Halstead MichaelPresident | Sale | 7,345 | $65.97 | $484.5K | Form 4 |
| Mar 11, 2024 | Neumann MarkEVP, Chief Commercial Officer | Sale | 7,345 | $65.61 | $481.9K | Form 4 |
| Mar 11, 2024 | Durgam Suresh K.EVP, Chief Medical Officer | Sale | 3,712 | $65.59 | $243.5K | Form 4 |
All 111 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- JPMorgan ChaseSCHEDULE 13G/A, 2 filings Oct 10, 2024 to Jun 5, 202549
- FMR LLCSCHEDULE 13G/A, 5 filings Feb 9, 2022 to Feb 7, 202550
- BlackRockSC 13G/A, 2 filings Oct 24, 2024 to Nov 8, 202451
- VANGUARD GROUP INCSC 13G/A, 3 filings Feb 10, 2022 to Feb 13, 202452
- WASATCH ADVISORS LPSC 13G/A, 4 filings Dec 2, 2021 to Feb 9, 202453
- Wellington Management CompanySC 13G/A, 2 filings Feb 6, 2023 to Feb 8, 202454
SEC filer profile
How Intra-Cellular Therapies, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARIntra-Cellular Therapies, Inc.1
- CIK0001567514
- Employer ID (EIN)36-47428504
- Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address135 Route 202/206, Suite 6, Bedminster, NJ 079211
- Phone(646) 440-93331
- Shares outstanding106,521,576 as of Mar 10, 202555
- Public float$7.1B as of Jun 28, 20244
- AuditorErnst & Young LLP, Baltimore, Maryland PCAOB ID 42; it also attests to the company’s internal control over financial reporting4
- On EDGAR sinceFeb 8, 20131
- Filings1,007 in all: 4 (527), 8-K (139), 144 (53), SC 13G/A (41), 10-Q (35), 3 (25), DEFA14A (15), 424B5 (14)1
All 50 form types
10-K (13), UPLOAD (13), 424B3 (12), DEF 14A (11), SC 13G (11), 4/A (10), CORRESP (9), EFFECT (9), S-8 (6), S-8 POS (6), CT ORDER (5), DFAN14A (4), POS AM (4), S-3 (4), 8-K/A (3), S-1/A (3), SC 13D (3), SC 13D/A (3), 144/A (2), ARS (2), S-1 (2), S-3ASR (2), SCHEDULE 13G/A (2), 10-12G (1), 10-12G/A (1), 10-K/A (1), 15-12G (1), 25-NSE (1), 424B1 (1), 5 (1), 8-A12B (1), CERTNAS (1), D (1), DEF 14C (1), DEFM14A (1), NT 10-K (1), POSASR (1), PRE 14A (1), PRE 14C (1), PREM14A (1), S-1MEF (1), SC 14F1 (1)
- Latest filingsAnnual report (10-K) Feb 21, 2025
Quarterly report (10-Q) Oct 30, 2024
Proxy statement (DEF 14A) Apr 29, 2024
Latest 8-K (8-K) Apr 2, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock | ITCI | The Nasdaq Global Select Market |
From the cover page of the 10-K filed Feb 21, 2025 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Intra-Cellular Therapies, Inc. names in Item 1A of its 10-K filed Feb 21, 2025: 56 risks under these headings, as written.4
- You should consider carefully the following risk factors, together with all of the other information included or incorporated by reference in this report. If any of the following risks, either alone or taken together, or other risks not presently known to us or that we currently believe to not be significant, develop into actual events, then our business, financial condition, results of operations or prospects could be materially adversely affected. If that happens, the market price of our common stock could decline, and stockholders may lose all or part of their investment.
- Risks Related to the Pending Transaction With Johnson & Johnson
- We may not complete the pending transaction with Johnson & Johnson within the time frame we anticipate or at all, which could have an adverse effect on our business, financial results, operations and/or the market price of our common stock.
- The pendency of the Merger with Johnson & Johnson could adversely affect our business, financial results, operations and/or the market price of our common stock.
- While the Merger Agreement is in effect, we are subject to restrictions on our business activities.
- The Merger Agreement contains provisions that could make it difficult for a third party to acquire us prior to the completion of the Merger.
- A lawsuit may be filed against us and/or Johnson & Johnson challenging the transactions contemplated by the Merger Agreement. An adverse ruling in any such lawsuit may delay or prevent the Merger from being completed.
- We have incurred, and will continue to incur, direct and indirect costs as a result of the pending transaction with Johnson & Johnson.
- Risks Related to Our Business
- In order to execute our business plan and achieve profitability, we need to continue to effectively expand the commercialization of CAPLYTA, which has been approved by the FDA for the treatment of schizophrenia in adults and for the treatment of bipolar depression in adults.
- If we do not obtain regulatory approval of lumateperone for other indications in the United States, or for any indication in foreign jurisdictions, we will not be able to market lumateperone for other indications or in other jurisdictions, which will limit our commercial revenues.
- If the sales and marketing capabilities we have established or our third-party relationships for the commercialization of CAPLYTA are not effective, we may not be able to continue to grow our product revenues.
The other 46 risks
- We have generated revenues from product sales but there is no guarantee that our revenues from the sale of CAPLYTA will result in us achieving profitability.
- There is no guarantee that our planned clinical trials for lumateperone or our other product candidates will be successful.
- We expect our net losses to continue and are unable to predict the extent of future losses or when we will become profitable, if ever.
- We may require additional funding, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations.
- Our management has broad discretion over the use of our cash and we may not use our cash effectively, which could adversely affect our results of operations.
- Delays, suspensions and terminations in our clinical trials or the need to conduct additional clinical trials or non-clinical studies could result in increased costs to us, delay our ability to generate product revenues and therefore may have a material adverse effect on our business, results of operations and future growth prospects.
- Even if we successfully complete the clinical trials of one or more of our product candidates, the product candidates may fail for other reasons.
- Even though the FDA has granted approval of CAPLYTA for the treatment of schizophrenia and bipolar depression, the terms of the approval may limit its commercial potential.
- Safety issues with our product candidates or approved product, or with product candidates or approved products of third parties that are similar to our product candidates, could give rise to delays in the regulatory approval process, restrictions on labeling or product withdrawal after approval.
- If we seek to enter into strategic alliances for our drug candidates, but fail to enter into and maintain successful strategic alliances, we may have to reduce or delay our drug candidate development or increase our expenditures.
- To the extent we are able to enter into collaborative arrangements or strategic alliances, we will be exposed to risks related to those collaborations and alliances.
- Preliminary and interim data from our clinical trials that we may announce or publish from time to time may change as more patient data become available.
- We rely on third parties to conduct our clinical trials and perform data collection and analysis, which may result in costs and delays that prevent us from successfully commercializing our product candidates.
- Our employees, independent contractors, principal investigators, contract research organizations, consultants or vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- We are subject to ongoing regulatory obligations and restrictions with regard to CAPLYTA and, following regulatory approval of any of our product candidates, we will be subject to ongoing regulatory obligations and restrictions with regard to such product candidates, which may result in significant expense and limit our ability to commercialize lumateperone and our other potential products.
- CAPLYTA and our product candidates, if approved, may not gain or maintain acceptance among physicians, patients, or the medical community, thereby limiting our potential to generate revenues, which will undermine our future growth prospects.
- The failure to attract and retain skilled personnel and key relationships could impair our drug development and commercialization efforts.
- We rely on third-party manufacturers to manufacture and supply lumateperone and our other product candidates for us. If one of our suppliers or manufacturers fails to perform adequately or fulfill our needs, we may be required to incur significant costs and devote significant efforts to find new suppliers or manufacturers. We may also face significant delays in our clinical trials, regulatory approvals and product introductions and commercialization.
- As our business expands and evolves, we may find that our staffing is not adequate in size or capability to manage these changes and to perform under the new circumstances.
- Our ability to generate product revenues will be diminished if lumateperone or any of our other potential products do not sell for adequate prices, receive coverage from payers or if patients are unable to obtain adequate levels of reimbursement.
- Health care legislation may make it more difficult to receive revenues from CAPLYTA or future products.
- We currently have limited experience as a company in marketing and distributing pharmaceutical products and rely on third-party distributors to distribute CAPLYTA. If we are unable to continue to effectively commercialize CAPLYTA, we may not be able to generate adequate product revenues.
- The FDA has granted marketing approval of CAPLYTA for the treatment of schizophrenia in adults and the treatment of bipolar depression in adults, and we could face liability if a regulatory authority determines that we are promoting CAPLYTA for any “off-label” uses.
- We may be unable to use certain of our net operating losses and other tax assets.
- Changes in tax laws could adversely affect our business and financial condition.
- Cybersecurity incidents, loss of data and other disruptions could compromise sensitive information related to our business, prevent us from accessing critical information, impact our ability to manufacture, distribute and sell CAPLYTA and any future products, or expose us to liability and reputational harm. Any of these risks could adversely affect our business and our reputation.
- Public health threats could have a material impact on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials and non-clinical studies.
- Risks Related to Our Intellectual Property
- Our ability to compete may be undermined if we do not adequately protect our proprietary rights.
- CAPLYTA and future product candidates for which we obtain approval may face competition sooner than anticipated.
- Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete.
- A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business.
- The patent applications of pharmaceutical and biotechnology companies involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position.
- We may not be able to protect our intellectual property and proprietary rights throughout the world, which could negatively impact our business.
- Risks Related to Our Industry
- We are subject to stringent regulation in connection with the marketing of CAPLYTA and any other products derived from our product candidates, which could delay the development and commercialization of our products.
- Many of our competitors have greater resources and capital than us, putting us at a competitive disadvantage. If our competitors develop and market products that are more widely accepted in the marketplace than lumateperone or our other product candidates, they may negatively affect or eliminate our commercial opportunity.
- Our business involves the use of hazardous materials, and we and our third party manufacturers and suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do, or interrupt, our business. Any claims relating to improper handling, storage, or disposal of biological, hazardous, and radioactive materials used in our business could be costly and delay our research and development and commercial efforts.
- We are subject, directly and indirectly, to federal, state and foreign healthcare laws and regulations, including healthcare fraud and abuse laws, false claims laws, physician payment transparency laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of CAPLYTA or any other product for which we obtain regulatory approval, or development or commercialization of our product candidates.
- Unfavorable domestic or global economic conditions could adversely affect our business, financial condition, or results of operations.
- Risks Related to Owning Our Common Stock
- Numerous factors could result in substantial market volatility in the trading price of our common stock.
- Raising additional capital may cause dilution to existing stockholders, restrict our operations or require us to relinquish rights.
- We incur substantial costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could harm our operating results.
- If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, our ability to operate our business and investors’ views of us.
- If securities or industry analysts do not publish, or cease publishing, research or reports about us, our business or our market, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
- Provisions of the Delaware law, our restated certificate of incorporation and our restated bylaws may delay or prevent a takeover which may not be in the best interests of our stockholders.
- We do not anticipate paying cash dividends in the foreseeable future.
Legal proceedings
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.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 15SEC EDGARMichael Halstead, President
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- 25SEC EDGAREduardo Rene Salas, Board member
- 26SEC EDGARNostrand Robert L. Van, Board member
- 27SEC EDGARChristopher D. Alafi, Board member
- 28SEC EDGARMichael Rawlins, Board member
- 29SEC EDGARRichard A. Lerner, Board member
- 30SEC EDGARJoel S. Marcus, Board member
- 31SEC EDGARMichael Halstead, General counsel
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- 33SEC EDGARShareholder vote
- 34SEC EDGAROther events
- 35SEC EDGAROther events
- 36SEC EDGARResults of operations; Other events
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- 41SEC EDGARResults of operations; Other events
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