QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
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(Address of principal executive offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
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☒ |
Accelerated filer |
☐ | |||
Non-accelerated filer |
☐ |
Smaller reporting company |
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Emerging growth company |
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1 |
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Item 1. |
1 |
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1 |
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2 |
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3 |
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4 |
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5 |
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6 |
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Item 2. |
17 |
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Item 3. |
25 |
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Item 4. |
25 |
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26 |
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Item 1. |
26 |
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Item 1A. |
26 |
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Item 2. |
26 |
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Item 3. |
26 |
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Item 4. |
26 |
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Item 5. |
26 |
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Item 6. |
27 |
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28 |
Item 1. |
FINANCIAL STATEMENTS |
September 30, 2019 |
December 31, 2018 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
$ | ||||||
Investment securities, available-for-sale |
||||||||
Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Right of use assets, net |
— |
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Deferred tax asset, net |
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Other assets |
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Total assets |
$ |
$ | ||||||
Liabilities and stockholders’ equity |
||||||||
Current liabilities: |
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Accounts payable |
$ |
$ | ||||||
Accrued and other current liabilities |
||||||||
Lease liabilities, short-term |
— |
|||||||
Accrued employee benefits |
||||||||
Total current liabilities |
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Deferred rent |
— |
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Lease liabilities |
— |
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Total liabilities |
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Stockholders’ equity: |
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Common stock, $ |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) |
( |
) | ||||
Accumulated comprehensive gain/(loss) |
( |
) | ||||||
Total stockholders’ equity |
||||||||
Total liabilities and stockholders’ equity |
$ |
$ | ||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
Revenues |
$ |
|
$ | — |
$ |
— |
$ | — |
||||||||
Costs and expenses: |
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Research and development |
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General and administrative |
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|
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Total costs and expenses |
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|
|
|
||||||||||||
Loss from operations |
( |
) |
( |
) | ( |
) |
( |
) | ||||||||
Interest income |
|
|
|
|
||||||||||||
Loss before provision for income taxes |
( |
) |
( |
) | ( |
) |
( |
) | ||||||||
Income tax expense |
— |
— |
|
|
||||||||||||
Net loss |
$ |
( |
) |
$ | ( |
) | $ |
( |
) |
$ | ( |
) | ||||
Net loss per common share: |
||||||||||||||||
Basic & Diluted |
$ |
( |
) |
$ | ( |
) | $ |
( |
) |
$ | ( |
) | ||||
Weighted average number of common shares: |
||||||||||||||||
Basic & Diluted |
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|
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
Net loss |
$ |
( |
) |
$ | ( |
) | $ |
( |
) |
$ | ( |
) | ||||
Other comprehensive income/(loss): |
||||||||||||||||
Unrealized (loss) / on investment securities gain |
( |
) |
|
|
( |
) | ||||||||||
Comprehensive loss |
$ |
( |
) |
$ | ( |
) | $ |
( |
) |
$ | ( |
) | ||||
Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Accumulated Comprehensive Gain ( Loss) |
Total Stockholders’ Equity |
||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||
Balance at June 30, 2018 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
Exercise of stock options and issuances of restricted stock |
— |
— |
— |
|||||||||||||||||||||
Stock issued for services |
— |
— |
||||||||||||||||||||||
Share-based compensation |
— |
— |
— |
— |
||||||||||||||||||||
Exercise of stock warrant |
— |
— |
— |
|||||||||||||||||||||
Net loss |
— |
— |
— |
( |
) | — |
( |
) | ||||||||||||||||
Other comprehensive income |
— |
— |
— |
— |
||||||||||||||||||||
Balance at September 30, 2018 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Accumulated Comprehensive Gain ( Loss) |
Total Stockholders’ Equity |
||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||
Balance at December 31, 2017 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
Exercise of stock options and issuances of restricted stock |
— |
— |
||||||||||||||||||||||
Stock issued for services |
— |
— |
||||||||||||||||||||||
Share-based compensation |
— |
— |
— |
— |
||||||||||||||||||||
Exercise of stock warrant |
— |
— |
— |
|||||||||||||||||||||
Net loss |
— |
— |
— |
( |
) | — |
( |
) | ||||||||||||||||
Other comprehensive loss |
— |
— |
— |
— |
( |
) | ( |
) | ||||||||||||||||
Balance at September 30, 2018 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
Common Stock |
Additional Paid-in Capital |
Accumulated Deficit |
Accumulated Comprehensive Gain ( Loss) |
Total Stockholders’ Equity |
||||||||||||||||||||
Shares |
Amount |
|||||||||||||||||||||||
Balance at June 30, 2019 |
$ |
$ |
$ |
( |
) |
$ |
$ |
|||||||||||||||||
Exercise of stock options and issuances of restricted stock |
— |
— |
||||||||||||||||||||||
Stock issued for services |
— |
— |
— |
|||||||||||||||||||||
Share-based compensation |
— |
— |
— |
— |
||||||||||||||||||||
Net loss |
— |
— |
— |
( |
) |
— |
( |
) | ||||||||||||||||
Other comprehensive loss |
— |
— |
— |
— |
( |
) |
( |
) | ||||||||||||||||
Balance at September 30, 2019 |
$ |
$ |
$ |
( |
) |
$ |
$ |
|||||||||||||||||
Common Stock |
Additional |
Accumulated |
Total |
|||||||||||||||||||||
Shares |
Amount |
Paid-in Capital |
Accumulated Deficit |
Comprehensive Gain (Loss) |
Stockholders’ Equity |
|||||||||||||||||||
Balance at December 31, 2018 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||||||
Exercise of stock options and issuances of restricted stock |
— |
— |
||||||||||||||||||||||
Stock issued for services |
— |
— |
||||||||||||||||||||||
Share-based compensation |
— |
— |
— |
— |
||||||||||||||||||||
Net loss |
— |
— |
— |
( |
) |
— |
( |
) | ||||||||||||||||
Other comprehensive income |
— |
— |
— |
— |
||||||||||||||||||||
Balance at September 30, 2019 |
$ |
$ |
$ |
( |
) |
$ |
$ |
Nine Months Ended September 30, |
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2019 |
2018 |
|||||||
Cash flows used in operating activities |
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Net loss |
$ |
( |
) |
$ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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Share-based compensation |
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|
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Stock issued for services |
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|
||||||
Amortization of premiums and discounts on investment securities, net |
( |
) |
( |
) | ||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses and other assets |
|
( |
) | |||||
Accounts payable |
( |
) |
|
|||||
Accrued liabilities and other |
|
|
||||||
Deferred rent |
— |
( |
) | |||||
Net cash used in operating activities |
( |
) |
( |
) | ||||
Cash flows provided by investing activities |
||||||||
Purchases of investments |
( |
) |
( |
) | ||||
Maturities of investments |
|
|
||||||
Purchases of property and equipment |
( |
) |
( |
) | ||||
Net cash provided by investing activities |
|
|
||||||
Cash flows provided by financing activities |
||||||||
Proceeds from exercise of stock options |
|
|
||||||
Proceeds from exercise of warrants |
— |
|
||||||
Net cash provided by financing activities |
|
|
||||||
Net increase in cash and cash equivalents |
|
|
||||||
Cash and cash equivalents at beginning of period |
|
|
||||||
Cash and cash equivalents at end of period |
$ |
|
$ | |
||||
Non-cash investing and financing activities |
||||||||
Right of use assets under operating leases |
$ |
|
$ | — |
||||
September 30, 2019 |
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Amortized Cost |
Unrealized Gains |
Unrealized (Losses) |
Estimated Fair Value |
|||||||||||||
(Unaudited) |
||||||||||||||||
U.S. Government Agency Securities |
$ | |
$ | |
$ | ( |
) | $ | |
|||||||
Certificates of Deposit |
|
— |
— |
|
||||||||||||
Commercial Paper |
|
|
( |
) | |
|||||||||||
Corporate Notes/Bonds |
|
|
( |
) | |
|||||||||||
$ | |
$ | |
$ | ( |
) | $ | 153,271 |
||||||||
December 31, 2018 |
||||||||||||||||
Amortized Cost |
Unrealized Gains |
Unrealized (Losses) |
Estimated Fair Value |
|||||||||||||
U.S. Government Agency Securities |
$ | |
$ | |
$ | ( |
) | $ | |
|||||||
FDIC Certificates of Deposit (1) |
|
— |
— |
|
||||||||||||
Certificates of Deposit |
|
— |
— |
|
||||||||||||
Commercial Paper |
|
— |
( |
) | |
|||||||||||
Corporate Notes/Bonds |
|
|
( |
) | |
|||||||||||
$ | |
$ | |
$ | ( |
) | $ | 292,583 |
||||||||
(1) | “FDIC Certificates of Deposit” consist of deposits that are less than $ |
• |
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. |
Fair Value Measurements at Reporting Date Using |
||||||||||||||||
September 30, 2019 |
Quoted Prices in Active Markets for Identical Assets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
|||||||||||||
Money Market Funds |
$ | |
$ | |
$ | — |
$ | — |
||||||||
U.S. Government Agency Securities |
|
— |
|
— |
||||||||||||
Certificates of Deposit |
|
— |
|
— |
||||||||||||
Commercial Paper |
|
— |
|
— |
||||||||||||
Corporate Notes/Bonds |
|
— |
|
— |
||||||||||||
$ | |
$ | |
$ | |
$ | — |
|||||||||
Fair Value Measurements at Reporting Date Using |
||||||||||||||||
December 31, 2018 |
Quoted Prices in Active Markets for Identical Assets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
|||||||||||||
Money Market Funds |
$ | |
$ | |
$ | — |
$ | — |
||||||||
U.S. Government Agency Securities |
|
— |
|
— |
||||||||||||
FDIC Certificates of Deposit |
|
— |
|
— |
||||||||||||
Certificates of Deposit |
|
— |
|
— |
||||||||||||
Commercial Paper |
|
— |
|
— |
||||||||||||
Corporate Notes/Bonds |
|
— |
|
— |
||||||||||||
|
||||||||||||||||
$ | |
$ | |
$ | |
$ | — |
|||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
Stock options |
||||||||||||||||
RSUs |
||||||||||||||||
TSR RSUs |
September 30, 2019 |
December 31, 2018 |
|||||||
Computer equipment |
$ |
$ | ||||||
Furniture and fixtures |
||||||||
Scientific equipment |
||||||||
Leasehold improvements |
||||||||
Less accumulated depreciation |
( |
) |
( |
) | ||||
$ |
$ | |||||||
Three months ending December 31, 2019 |
$ | ( |
) | |
Year end ing December 31, 2020 |
||||
Year end ing December 31, 2021 |
||||
Year end ing December 31, 2022 |
||||
Year end ing December 31, 2023 |
||||
Thereafter |
||||
Total |
||||
Less: Present value discount |
( |
) | ||
Total Lease liability |
$ | |||
Less: current portion |
( |
) | ||
Long-term lease liabilities |
$ | |||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
Research and development |
$ |
$ | $ |
$ | ||||||||||||
General and administrative |
||||||||||||||||
Total share-based compensation expense |
$ |
$ | $ |
$ | ||||||||||||
2019 |
2018 |
|||||||
Dividend yield |
||||||||
Expected volatility |
||||||||
Weighted-average risk-free interest rate |
||||||||
Expected term (in years) |
Number of Shares |
Weighted- Average Exercise Price |
Weighted- Average Contractual Life |
||||||||||
Outstanding at December 31, 2018 |
$ | |||||||||||
Options granted |
$ | |||||||||||
Options exercised |
( |
) | $ | |||||||||
Options canceled or expired |
( |
) | $ | |||||||||
Outstanding at September 30, 2019 |
$ | |||||||||||
Vested or expected to vest at September 30, 2019 |
$ | |||||||||||
Exercisable at September 30, 2019 |
$ | |||||||||||
Number of Shares |
Weighted-Average Grant Date Fair Value Per Share |
|||||||
Outstanding at December 31, 2018 |
$ | |||||||
Time based RSUs granted in 2019 |
$ | |||||||
Time based RSUs vested in 2019 |
( |
) | $ | |||||
Time based RSUs cancelled in 2019 |
( |
) | $ | |||||
Outstanding at September 30, 2019 |
$ | |||||||
Number of Shares |
Weighted-Average Grant Date Fair Value Per Share |
|||||||
Outstanding at December 31, 2018 |
$ | |||||||
Milestone RSUs and TSR RSUs granted in 2019 |
— |
$ | — |
|||||
Milestone RSUs and TSR RSUs cancelled in 2019 |
( |
) | $ | |||||
Outstanding at September 30, 2019 |
$ | |||||||
Item 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
• |
internal recurring costs, such as costs relating to labor and fringe benefits, materials, supplies, facilities and maintenance; and |
• |
fees paid to external parties who provide us with contract services, such as pre-clinical testing, manufacturing and related testing, clinical trial activities and license milestone payments. |
• |
salaries and related benefit costs; |
• |
patent, legal, professional and pre-commercialization costs; and |
• |
office and facilities overhead. |
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
(Unaudited) |
(Unaudited) |
|||||||||||||||
Revenues |
$ |
— |
$ | — |
$ |
— |
$ | — |
||||||||
Expenses |
||||||||||||||||
Research and development |
21,340 |
35,419 |
70,059 |
98,561 |
||||||||||||
General and administrative |
15,036 |
7,972 |
42,184 |
21,082 |
||||||||||||
Total costs and expenses |
36,376 |
43,391 |
112,243 |
119,643 |
||||||||||||
Loss from operations |
(36,376 |
) |
(43,391 |
) | (112,243 |
) |
(119,643 |
) | ||||||||
Interest income |
1,514 |
1,868 |
5,106 |
5,266 |
||||||||||||
Income tax expense |
— |
— |
(2 |
) |
(2 |
) | ||||||||||
Net loss |
$ |
(34,862 |
) |
$ | (41,523 |
) | $ |
(107,139 |
) |
$ | (114,379 |
) | ||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
External costs |
14,372 |
29,690 |
48,302 |
82,813 |
||||||||||||
Internal costs |
6,968 |
5,729 |
21,757 |
15,748 |
||||||||||||
Total research and development expenses |
$ |
21,340 |
$ | 35,419 |
$ |
70,059 |
$ | 98,561 |
||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
Lumateperone costs |
1 0 , 515 |
22,653 |
32 ,282 |
60,819 |
||||||||||||
Manufacturing costs |
3,061 |
4,905 |
14,920 |
17,543 |
||||||||||||
Stock based compensation |
2,024 |
1,819 |
6,785 |
5,615 |
||||||||||||
Other projects and overhead |
5 ,740 |
6,042 |
16 ,072 |
14,584 |
||||||||||||
Total research and development expenses |
$ |
21,340 |
$ | 35,419 |
$ |
70,059 |
$ | 98,561 |
||||||||
• |
completion of extensive pre-clinical laboratory tests, animal studies, and formulation studies in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations; |
• |
submission to the FDA of an Investigational New Drug application, or IND, for human clinical testing, which must become effective before human clinical trials may begin; |
• |
performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug for each proposed indication; |
• |
submission to the FDA of a New Drug Application, or NDA, after completion of all clinical trials; |
• |
satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the active pharmaceutical ingredient, or API, and finished drug product are produced and tested to assess compliance with current Good Manufacturing Practices, or cGMPs; |
• |
satisfactory completion of FDA inspections of clinical trial sites to assure that data supporting the safety and effectiveness of product candidates has been generated in compliance with Good Clinical Practices; and |
• |
FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the United States. |
Item 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Item 4. |
CONTROLS AND PROCEDURES |
Item 1. |
LEGAL PROCEEDINGS |
Item 1A. |
RISK FACTORS |
Item 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Item 3. |
DEFAULTS UPON SENIOR SECURITIES |
Item 4. |
MINE SAFETY DISCLOSURES |
Item 5. |
OTHER INFORMATION |
Item 6. |
EXHIBITS |
Exhibit Number |
Exhibit Description |
Filed Herewith |
Incorporated by Reference herein from Form or Schedule |
Filing Date |
SEC File/ Reg. Number | |||||||
10.1 |
X |
Form S-3 (Exhibit 1.2) |
8/30/2019 |
333-233537 | ||||||||
31.1 |
X |
|||||||||||
31.2 |
X |
|||||||||||
32 |
X |
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101 |
The following materials from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, formatted in Inline XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets as of September 30, 2019 (unaudited) and December 31, 2018 (audited), (ii) Condensed Consolidated Statements of Operations (unaudited) for the three and nine months ended September 30, 2019 and 2018, (iii) Condensed Consolidated Statements of Comprehensive Loss (unaudited) for the three and nine months ended September 30, 2019 and 2018, (iv) Condensed Consolidated Statements of Stockholders’ Equity (unaudited) for the three and nine months ended September 30, 2019 and 2018, (v) Condensed Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2019 and 2018, and (vi) Notes to Condensed Consolidated Financial Statements (unaudited). |
X |
||||||||||
104 |
Cover Page Interactive Date File (formatted as Inline XBRL and contained in Exhibit 101). |
X |
INTRA-CELLULAR THERAPIES, INC. | ||||||
Date: November 5, 2019 |
By: |
/s/ Sharon Mates, Ph.D. | ||||
Sharon Mates, Ph.D. | ||||||
Chairman, President and Chief Executive Officer | ||||||
Date: November 5, 2019 |
By: |
/s/ Lawrence J. Hineline | ||||
Lawrence J. Hineline | ||||||
Senior Vice President of Finance and Chief Financial Officer |
Exhibit 31.1
CERTIFICATIONS UNDER SECTION 302
I, Sharon Mates, Ph.D., certify that:
1. I have reviewed this quarterly report on Form 10-Q of Intra-Cellular Therapies, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
Date: November 5, 2019
/s/ Sharon Mates, Ph.D. |
Sharon Mates, Ph.D. |
Chairman, President and Chief Executive Officer (principal executive officer) |
Exhibit 31.2
CERTIFICATIONS UNDER SECTION 302
I, Lawrence J. Hineline, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Intra-Cellular Therapies, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
Date: November 5, 2019
/s/ Lawrence J. Hineline |
Lawrence J. Hineline |
Senior Vice President of Finance and Chief Financial Officer |
(principal financial officer) |
Exhibit 32
CERTIFICATIONS UNDER SECTION 906
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of Intra-Cellular Therapies, Inc., a Delaware corporation (the Company), does hereby certify, to such officers knowledge, that:
The Quarterly Report for the quarter ended September 30, 2019 (the Form 10-Q) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: November 5, 2019 | /s/ Sharon Mates, Ph.D. | |
Sharon Mates, Ph.D. | ||
Chairman, President and Chief Executive Officer | ||
(principal executive officer) | ||
Dated: November 5, 2019 | /s/ Lawrence J. Hineline | |
Lawrence J. Hineline | ||
Senior Vice President of Finance and Chief Financial Officer | ||
(principal financial officer) |