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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Intra Cellular Therapies Inc | NASDAQ:ITCI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.1299 | -0.19% | 66.7101 | 66.75 | 66.83 | 67.095 | 66.17 | 66.72 | 55,709 | 15:55:57 |
☒ |
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
|
Delaware
|
36-4742850
|
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification No.)
|
|
430 East 29th Street
New York, New York
|
10016
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Title of each class
|
Trading
Symbol(s)
|
Name of each exchange
on which registered
|
||
Common Stock
|
ITCI
|
The Nasdaq Global Select Market
|
Large accelerated filer | ☒ | Accelerated filer | ☐ | |||
Non-accelerated
filer
|
☐ | Smaller reporting company | ☐ | |||
Emerging growth company | ☐ |
March 31,
2021 |
December 31,
2020 |
|||||||
(Unaudited)
|
||||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
129,979,888
|
|
$ | 60,045,933 | |||
Investment securities,
available-for-sale
|
|
481,984,786
|
|
597,402,126 | ||||
Restricted cash
|
|
1,400,000
|
|
1,400,000 | ||||
Accounts receivable, net of $120,000 allowance at March 31, 2021 and December 31, 2020
|
|
13,661,992
|
|
10,764,583 | ||||
Inventory
|
|
7,579,393
|
|
7,056,385 | ||||
Prepaid expenses and other current assets
|
|
14,494,384
|
|
14,235,455 | ||||
|
|
|
|
|||||
Total current assets
|
|
649,100,443
|
|
690,904,482 | ||||
Property and equipment, net
|
|
1,871,338
|
|
1,998,346 | ||||
Right of use assets, net
|
|
23,430,703
|
|
24,324,762 | ||||
Other assets
|
|
86,084
|
|
86,084 | ||||
|
|
|
|
|||||
Total assets
|
$
|
674,488,568
|
|
$ | 717,313,674 | |||
|
|
|
|
|||||
Liabilities and stockholders’ equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
8,720,957
|
|
$ | 5,501,825 | |||
Accrued and other current liabilities
|
|
13,491,620
|
|
10,902,117 | ||||
Lease liabilities, short-term
|
|
5,573,240
|
|
5,541,802 | ||||
Accrued employee benefits
|
|
11,915,893
|
|
14,907,479 | ||||
|
|
|
|
|||||
Total current liabilities
|
|
39,701,710
|
|
36,853,223 | ||||
Lease liabilities
|
|
22,637,100
|
|
23,600,347 | ||||
|
|
|
|
|||||
Total liabilities
|
|
62,338,810
|
|
60,453,570 | ||||
Stockholders’ equity:
|
||||||||
Common stock, $0.0001 par value: 100,000,000 shares authorized; 81,133,849 and 80,463,089 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively
|
|
8,113
|
|
8,046 | ||||
Additional
paid-in
capital
|
|
1,601,739,075
|
|
1,593,475,506 | ||||
Accumulated deficit
|
|
(989,843,975
|
)
|
(937,104,032 | ) | |||
Accumulated comprehensive income
|
|
246,545
|
|
480,584 | ||||
|
|
|
|
|||||
Total stockholders’ equity
|
|
612,149,758
|
|
656,860,104 | ||||
|
|
|
|
|||||
Total liabilities and stockholders’ equity
|
$
|
674,488,568
|
|
$ | 717,313,674 | |||
|
|
|
|
Three Months Ended March 31,
|
||||||||
2021
|
2020 | |||||||
Revenues
|
||||||||
Product sales, net
|
$
|
15,578,905
|
|
$ | 882,516 | |||
Grant revenue
|
|
299,424
|
|
200,963 | ||||
|
|
|
|
|||||
Total revenues
|
|
15,878,329
|
|
1,083,479 | ||||
Operating expenses:
|
||||||||
Cost of product sales
|
|
1,455,215
|
|
69,311 | ||||
Research and development
|
|
15,058,168
|
|
16,003,326 | ||||
Selling, general and administrative
|
|
52,583,639
|
|
34,096,366 | ||||
|
|
|
|
|||||
Total operating expenses
|
|
69,097,022
|
|
50,169,003 | ||||
|
|
|
|
|||||
Loss from operations
|
|
(53,218,693
|
)
|
(49,085,524 | ) | |||
Interest income
|
|
483,750
|
|
1,678,203 | ||||
|
|
|
|
|||||
Loss before provision for income taxes
|
|
(52,734,943
|
)
|
(47,407,321 | ) | |||
Income tax expense
|
|
5,000
|
|
3,281 | ||||
|
|
|
|
|||||
Net los
s
|
$
|
(52,739,943
|
)
|
$ | (47,410,602 | ) | ||
|
|
|
|
|||||
Net loss per common share:
|
||||||||
Basic & Diluted
|
$
|
(0.65
|
)
|
$ | (0.73 | ) | ||
Weighted average number of common shares:
|
||||||||
Basic & Diluted
|
|
80,946,450
|
|
65,106,103 |
Three Months Ended March 31,
|
||||||||
2021
|
2020 | |||||||
Net loss
|
$
|
(52,739,943
|
)
|
$ | (47,410,602 | ) | ||
Other comprehensive (loss):
|
||||||||
Unrealized loss on investment securitie
s
|
|
(234,039
|
)
|
(273,516 | ) | |||
|
|
|
|
|||||
Comprehensive loss
|
$
|
(52,973,982
|
)
|
$ | (47,684,118 | ) | ||
|
|
|
|
Common Stock
|
Additional
Paid-in
Capital |
Accumulated
Deficit |
Accumulated
Comprehensive Income (Loss) |
Total
Stockholders’ Equity |
||||||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||||||
Balance at December 31, 2019
|
55,507,497 | $ | 5,551 | $ | 904,971,772 | $ | (710,098,369 | ) | $ | 128,317 | $ | 195,007,271 | ||||||||||||
Common shares issued
|
10,000,000 | 1,000 | 276,977,186 | — | — | 276,978,186 | ||||||||||||||||||
Exercise of stock options and issuances of restricted stock
|
689,781 | 69 | 589,092 | — | — | 589,161 | ||||||||||||||||||
Stock issued for services
|
3,483 | — | 53,533 | — | — | 53,533 | ||||||||||||||||||
Share-based compensation
|
— | — | 5,504,297 | — | — | 5,504,297 | ||||||||||||||||||
Net loss
|
— | — | — | (47,410,602 | ) | — | (47,410,602 | ) | ||||||||||||||||
Other comprehensive loss
|
— | — | — | — | (273,516 | ) | (273,516 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at March 31, 2020
|
66,200,761 | $ | 6,620 | $ | 1,188,095,880 | $ | (757,508,971 | ) | $ | (145,199 | ) | $ | 430,448,330 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Common Stock
|
Additional
Paid-in
Capital |
Accumulated
Deficit |
Accumulated
Comprehensive Income (Loss) |
Total
Stockholders’ Equity |
||||||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||||||
Balance at December 31, 2020
|
|
80,463,089
|
|
$
|
8,046
|
|
$
|
1,593,475,506
|
|
$
|
(937,104,032
|
)
|
$
|
480,584
|
|
$
|
656,860,104
|
|
||||||
Exercise of stock options and issuances of restricted stock
|
|
669,182
|
|
|
67
|
|
|
1,431,591
|
|
|
—
|
|
|
—
|
|
|
1,431,658
|
|
||||||
Stock issued for services
|
|
1,578
|
|
|
—
|
|
|
53,542
|
|
|
—
|
|
|
—
|
|
|
53,542
|
|
||||||
Share-based compensation
|
|
— |
|
|
—
|
|
|
6,778,436
|
|
|
—
|
|
|
—
|
|
|
6,778,436
|
|
||||||
Net loss
|
|
— |
|
|
—
|
|
|
—
|
|
|
(52,739,943
|
)
|
|
—
|
|
|
(52,739,943
|
)
|
||||||
Other comprehensive loss
|
|
— |
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(234,039
|
)
|
|
(234,039
|
)
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at March 31, 2021
|
|
81,133,849
|
|
$
|
8,113
|
|
$
|
1,601,739,075
|
|
$
|
(989,843,975
|
)
|
$
|
246,545
|
|
$
|
612,149,758
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
||||||||
2021
|
2020 | |||||||
Cash flows used in operating activities
|
||||||||
Net loss
|
$
|
(52,739,943
|
)
|
$ | (47,410,602 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
|
127,008
|
|
148,802 | ||||
Share-based compensation
|
|
6,778,436
|
|
5,504,297 | ||||
Stock issued for services
|
|
53,542
|
|
53,533 | ||||
Amortization of premiums and discounts on investment securities, net
|
|
(1,085,948
|
)
|
(298,210 | ) | |||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable, net
|
|
(2,897,409
|
)
|
(1,351,013 | ) | |||
Inventory
|
|
(523,008
|
)
|
(1,391,124 | ) | |||
Prepaid expenses and other assets
|
|
(258,929
|
)
|
(1,562,620 | ) | |||
Long term deferred tax asset, net
|
|
—
|
|
264,609 | ||||
Accounts payable
|
|
3,219,132
|
|
3,569,058 | ||||
Accrued liabilities and othe
r
|
|
(402,083
|
)
|
(8,740,512 | ) | |||
Lease liabilities, net
|
|
(37,750
|
)
|
(12,436 | ) | |||
|
|
|
|
|||||
Net cash used in operating activities
|
|
(47,766,952
|
)
|
(51,226,218 | ) | |||
Cash flows provided by (used in) investing activities
|
||||||||
Purchases of investments
|
|
(34,147,683
|
)
|
(210,466,633 | ) | |||
Maturities of investments
|
|
150,416,932
|
|
57,503,736 | ||||
Purchases of property and equipment
|
|
0
|
|
(22,049 | ) | |||
|
|
|
|
|||||
Net cash provided by (used) in investing activities
|
|
116,269,249
|
|
(152,984,946 | ) | |||
Cash flows provided by financing activities
|
||||||||
Proceeds from exercise of stock options
|
|
1,431,658
|
|
589,161 | ||||
Proceeds of public offering, net
|
|
—
|
|
276,978,186 | ||||
|
|
|
|
|||||
Net cash provided by financing activities
|
|
1,431,658
|
|
277,567,347 | ||||
Net increase in cash, cash equivalents, and restricted cash
|
|
69,933,955
|
|
73,356,183 | ||||
Cash, cash equivalents, and restricted cash at beginning of period
|
|
61,445,933
|
|
107,636,849 | ||||
|
|
|
|
|||||
Cash, cash equivalents, and restricted cash at end of period
|
$
|
131,379,888
|
|
$ | 180,993,032 | |||
|
|
|
|
|||||
Non-cash
investing and financing activities
Right of use assets under operating leases
|
$
|
9,179,216
|
|
$ | 97,234 |
March 31,
|
||||||||
2021
|
2020
|
|||||||
Cash and cash equivalents
|
$ |
129,979,888
|
$ | 179,593,032 | ||||
Restricted cash
|
|
1,400,000
|
|
1,400,000 | ||||
|
|
|
|
|||||
Total cash, cash equivalents and restricted cash
|
$ |
131,379,888
|
$ | 180,993,032 | ||||
|
|
|
|
March 31, 2021
|
||||||||||||||||
Amortized
Cost |
Unrealized
Gains |
Unrealized
(Losses) |
Estimated
Fair Value |
|||||||||||||
(Unaudited)
|
||||||||||||||||
U.S. Government Agency Securities
|
$ | 188,996 | $ | 10 | $ | (47 | ) | $ | 188,959 | |||||||
Certificates of Deposit
|
10,500 | — | — | 10,500 | ||||||||||||
Commercial Paper
|
90,426 | 13 | (4 | ) | 90,435 | |||||||||||
Corporate Notes/Bonds
|
191,816 | 378 | (103 | ) | 192,091 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | 481,738 | $ | 401 | $ | (154 | ) | $ | 481,985 | ||||||||
|
|
|
|
|
|
|
|
December 31, 2020
|
||||||||||||||||
Amortized
Cost |
Unrealized
Gains |
Unrealized
(Losses) |
Estimated
Fair Value |
|||||||||||||
U.S. Government Agency Securities
|
$ | 259,304 | $ | 3 | $ | (31 | ) | $ | 259,276 | |||||||
Certificates of Deposit
|
10,500 | — | — | 10,500 | ||||||||||||
Commercial Paper
|
124,368 | 23 | (21 | ) | 124,370 | |||||||||||
Corporate Notes/Bonds
|
202,749 | 624 | (117 | ) | 203,256 | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
$ | 596,921 | $ | 650 | $ | (169 | ) | $ | 597,402 | ||||||||
|
|
|
|
|
|
|
|
• |
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 |
||||||||||||||||
March 31,
2021 |
Quoted Prices
in Active Markets for Identical Assets (Level 1) |
Significant
Other Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
|||||||||||||
Money Market Funds
|
$ | 83,602 | $ | 83,602 | $ | — | $ | — | ||||||||
U.S. Government Agency Securities
|
188,959 | — | 188,959 | — | ||||||||||||
Certificates of Deposit
|
10,500 | — | 10,500 | — | ||||||||||||
Commercial Paper
|
90,435 | — | 90,435 | — |
Fair Value Measurements at
Reporting Date Using |
||||||||||||||||
March 31,
2021 |
Quoted Prices
in Active Markets for Identical Assets (Level 1) |
Significant
Other Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
|||||||||||||
Corporate Notes/Bonds
|
192,091 | — | 192,091 | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
$
|
565,587
|
|
$
|
83,602
|
|
$
|
481,985
|
|
$
|
0
|
||||||
|
|
|
|
|
|
|
|
Fair Value Measurements at
Reporting Date Using
|
||||||||||||||||
December 31,
2020 |
Quoted Prices
in Active Markets for Identical Assets (Level 1) |
Significant
Other Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
|||||||||||||
Money Market Funds
|
$ | 27,917 | $ | 27,917 | $ | — | $ | — | ||||||||
U.S. Government Agency Securities
|
259,276 | — | 259,276 | — | ||||||||||||
Certificates of Deposit
|
10,500 | — | 10,500 | — | ||||||||||||
Commercial Paper
|
124,370 | — | 124,370 | — | ||||||||||||
Corporate Notes/Bonds
|
203,256 | — | 203,256 | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
$
|
625,319
|
|
$
|
27,917
|
|
$
|
597,402
|
|
$
|
—
|
||||||
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
||||||||
2021
|
2020
|
|||||||
Stock options
|
5,929,884 | 6,408,389 | ||||||
RSUs
|
1,669,434 | 1,695,397 | ||||||
TSR RSUs
|
68,598 | 86,044 |
March 31,
2021 |
December 31,
2020 |
|||||||
Raw materials
|
$
|
2,949,990
|
|
$
|
2,483,801
|
|||
Work in process
|
|
1,189,535
|
|
|
1,781,101
|
|
||
Finished goods
|
|
3,439,868
|
|
|
2,791,483
|
|
||
|
|
|
|
|||||
$
|
7,579,393
|
|
$
|
7,056,385
|
|
|||
|
|
|
|
March 31,
2021 |
December 31,
2020 |
|||||||
Computer equipment
|
$
|
243,532
|
|
$ | 243,532 | |||
Furniture and fixtures
|
|
423,097
|
|
423,097 | ||||
Scientific equipment
|
|
4,127,951
|
|
4,127,951 | ||||
Leasehold improvements
|
|
1,240,315
|
|
1,240,315 | ||||
|
|
|
|
|||||
|
6,034,895
|
|
6,034,895 | |||||
Less accumulated depreciation
|
|
(4,163,557
|
)
|
(4,036,549 | ) | |||
|
|
|
|
|||||
$
|
1,871,338
|
|
$ | 1,998,346 | ||||
|
|
|
|
March 31,
2021 |
December 31,
2020 |
|||||||
Accrued expenses
|
$ | 9,340,951 | $ | 7,896,942 | ||||
Sales allowances
|
3,656,291 | 2,619,650 | ||||||
Medicaid rebates
|
494,378 | 385,525 | ||||||
|
|
|
|
|||||
Total accrued expenses and other current liabilities
|
$ | 13,491,620 | $ | 10,902,117 | ||||
|
|
|
|
Nine months ending December 31, 2021
|
$ | 2,592,270 | ||
Year ending December 31, 2022
|
3,491,166 | |||
Year ending December 31, 2023
|
3,566,466 | |||
Year ending December 31, 2024
|
3,675,196 | |||
Year ending December 31, 2025
|
3,787,248 | |||
Thereafter
|
13,839,791 | |||
|
|
|||
Total
|
30,952,137 | |||
Less: Present value discount
|
(9,467,757 | ) | ||
|
|
|||
Total Lease liability
|
21,484,380 | |||
|
|
|||
Less: Current portion
|
(3,309,063 | ) | ||
|
|
|||
Long-term lease liabilities
|
$ | 18,175,317 | ||
|
|
Lease Assets and Liabilities – Fleet
|
Classification
|
March 31, 2021
|
March 31, 2020
|
|||||||||
Assets
|
||||||||||||
Right of use assets, net
|
Operating lease right of use assets | $ | 6,725,876 | $ | 94,092 | |||||||
|
|
|
|
|||||||||
$ | 6,725,876 | $ | 94,092 | |||||||||
|
|
|
|
|||||||||
Liabilities
|
||||||||||||
Current
|
Lease Assets and Liabilities – Fleet
|
Classification
|
March 31, 2021
|
March 31, 2020
|
|||||||||
Lease liabilities, short-term
|
Operating lease liabilities | $ | 2,264,183 | $ | — | |||||||
Non-Current
|
||||||||||||
Lease liabilities
|
Non-current operating lease liabilities
|
4,461,693 | 94,092 | |||||||||
|
|
|
|
|||||||||
Total lease liabilities
|
$ | 6,725,876 | 94,092 | |||||||||
|
|
|
|
|||||||||
Weighted average remaining lease term
|
1.8 years |
2.4
|
||||||||||
Weighted average discount rate
|
1.73 | % | 1.80 | % |
Nine months ending December 31, 2021
|
$ | 1,772,477 | ||
Year ending December 31, 2022
|
3,458.694 | |||
Year ending December 31, 2023
|
1,640,640 | |||
Thereafter
|
— | |||
|
|
|||
Total
|
6,871,811 | |||
Less: Present value discount
|
(145,935 | ) | ||
|
|
|||
Total operating lease liabilities
|
6,725,876 | |||
|
|
|||
Less: Current portion
|
(2,264,183 | ) | ||
|
|
|||
Long-term lease liabilities
|
$ | 4,461,693 | ||
|
|
Three Months Ended
March 31, |
||||||||
2021
|
2020 | |||||||
Inventoriable costs
|
$
|
361,744
|
|
$ | 293,384 | |||
Research and development
|
|
1,960,564
|
|
2,006,855 | ||||
Selling, general and administrative
|
|
4,456,128
|
|
3,204,058 | ||||
|
|
|
|
|||||
Total share-based compensation expense
|
$
|
6,778,436
|
|
$ | 5,504,297 | |||
|
|
|
|
2021
|
2020
|
|||
Dividend yield
|
0%
|
0% | ||
Expected volatility
|
94.8%-94.9%
|
91.6%-92.5%
|
||
Weighted-average risk-free interest rate
|
0.82%
|
1.42% | ||
Expected term (in years)
|
6.0
|
6.0 |
Number of
Shares |
Weighted-
Average Exercise Price |
Weighted-
Average Contractual Life |
||||||||||
Outstanding at December 31, 2020
|
39,728 | $ | 17.18 |
9.2 years
|
||||||||
Options granted in 2021
|
— | $ | — | |||||||||
|
|
|
|
|
|
|||||||
Outstanding at March 31, 2021
|
39,728 | $ | 17.18 |
9.2 years
|
||||||||
|
|
|
|
|||||||||
Vested or expected to vest at March 31, 2021
|
39,728 | $ | 17.18 | |||||||||
|
|
|
|
|||||||||
Exercisable at March 31, 2021
|
13,243 | $ | 17.18 | |||||||||
|
|
|
|
Number of
Shares |
Weighted-
Average Grant Date Fair Value Per Share |
Weighted-
Average Contractual Life |
||||||||||
Outstanding at December 31, 2020
|
251,867 | $ | 16.03 | 2.2 years | ||||||||
Time based RSUs vested in 2021
|
(82,538 | ) | $ | 16.03 | 2.0 years | |||||||
Time based RSUs cancelled in 2021
|
(3,985 | ) | $ | 15.81 | 2.0 years | |||||||
|
|
|
|
|
|
|||||||
Outstanding at March 31, 2021
|
165,344 | $ | 16.03 | 2.0 years | ||||||||
|
|
|
|
|||||||||
Vested or expected to vest at March 31, 2021
|
165,344 | $ | 16.03 | |||||||||
|
|
|
|
|||||||||
Exercisable at March 31, 2021
|
— | $ | — | |||||||||
|
|
|
|
Number of
Shares |
Weighted-
Average Exercise Price |
Weighted-
Average Contractual Life |
||||||||||
Outstanding at December 31, 2020
|
5,477,894 | $ | 18.43 | 6.6 years | ||||||||
Options granted 2021
|
511,932 | $ | 36.73 | 9.9 years | ||||||||
Options exercised 2021
|
(78,983 | ) | $ | 17.82 | 6.7 years | |||||||
Options canceled or expired 2021
|
(20,717 | ) | $ | 16.30 | 8.4 years | |||||||
|
|
|
|
|
|
|||||||
Outstanding at March 31, 2021
|
5,890,156 | $ | 20.03 | 6.6 years | ||||||||
|
|
|
|
|||||||||
Vested or expected to vest at March 31, 2021
|
5,890,156 | $ | 20.03 | |||||||||
|
|
|
|
|||||||||
Exercisable at March 31, 2021
|
4,083,592 | $ | 18.72 | 5.7 years | ||||||||
|
|
|
|
Number of
Shares |
Weighted-Average
Grant Date Fair Value Per Share |
Weighted-
Average Contractual Life |
||||||||||
Outstanding at December 31, 2020
|
1,311,877 | $ | 18.77 | 1.7 years | ||||||||
Time based RSUs granted in 2021
|
702,830 | $ | 35.63 | 2.9 years | ||||||||
Time based RSUs vested in 2021
|
(574,516 | ) | $ | 17.41 | 1.0 years | |||||||
Time based RSUs cancelled in 2021
|
(4,699 | ) | $ | 23.94 | 1.9 years | |||||||
|
|
|
|
|
|
|||||||
Outstanding at March 31, 2021
|
1,435,492 | $ | 27.56 | 2.3 years | ||||||||
|
|
|
|
|
|
Number of
Shares |
Weighted-Average
Grant Date Fair Value Per Share |
Weighted-
Average Contractual Life |
||||||||||
Outstanding at December 31, 2020
|
72,678 | $ | 28.25 | 2.1 years | ||||||||
Milestone RSUs and TSR RSUs granted in 2021
|
64,518 | $ | 38.45 | 2.9 years | ||||||||
Milestone RSUs and TSR RSUs vested in 2021
|
— | $ | — | 0.0 years | ||||||||
|
|
|
|
|
|
|||||||
Outstanding at March 31, 2021
|
137,196 | $ | 33.04 | 5.7 years | ||||||||
|
|
|
|
|
|
Item 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
• |
direct costs of formulating, manufacturing and packaging drug product;
|
• |
overhead costs consisting of labor, customs, share-based compensation, shipping, outside inventory management and other miscellaneous operating costs; and
|
• |
royalty payments on product sales.
|
• |
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 of a dedicated sales force;
|
• |
sales operation costs; and
|
• |
marketing and promotion expenses.
|
• |
salaries and related benefit costs;
|
• |
patent, legal, and professional costs; and
|
• |
office and facilities overhead.
|
For the Three Months
Ended March 31, |
||||||||
2021
|
2020
|
|||||||
(Unaudited)
|
||||||||
Revenues
|
||||||||
Product sales, net
|
$
|
15,579
|
|
$ | 882 | |||
Grant revenue
|
|
299
|
|
201 | ||||
|
|
|
|
|||||
Total revenues, net
|
|
15,878
|
|
1,083 | ||||
Expenses
|
||||||||
Cost of product sales
|
|
1,455
|
|
69 | ||||
Research and development
|
|
15,058
|
|
16,003 | ||||
Selling, general and administrative
|
|
52,584
|
|
34,097 | ||||
|
|
|
|
|||||
Total costs and expenses
|
|
69,097
|
|
50,169 |
For the Three Months
Ended March 31, |
||||||||
2021
|
2020
|
|||||||
(Unaudited)
|
||||||||
Loss from operations
|
|
(53,219
|
)
|
(49,086 | ) | |||
Interest income
|
|
484
|
|
1,678 | ||||
Income tax expense
|
|
(5
|
)
|
(3 | ) | |||
|
|
|
|
|||||
Net loss
|
$
|
(52,740
|
)
|
$ | (47,411 | ) | ||
|
|
|
|
Three Months Ended March 31, | ||||||||
2021
|
2020 | |||||||
External costs
|
$
|
7,312
|
|
$ | 9,007 | |||
Internal costs
|
|
7,746
|
|
6,996 | ||||
|
|
|
|
|||||
Total research and development expenses
|
$
|
15,058
|
|
$ | 16,003 | |||
|
|
|
|
Three Months Ended March 31, | ||||||||
2021
|
2020 | |||||||
Lumateperone costs
|
$
|
8,527
|
|
$ | 7,046 | |||
Manufacturing costs
|
|
357
|
|
2,673 | ||||
Stock based compensation
|
|
2,322
|
|
2,300 | ||||
Other projects and overhead
|
|
3,852
|
|
3,984 | ||||
|
|
|
|
|||||
Total research and development expenses
|
$
|
15,058
|
|
$ | 16,003 | |||
|
|
|
|
• |
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
|
|||||||||||||
31.1 | Certification of the Registrant’s Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | X | ||||||||||||||||
31.2 | Certification of the Registrant’s Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | X | ||||||||||||||||
32 | Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | X | ||||||||||||||||
101 |
The following materials from the Registrant’s Quarterly Report on
Form 10-Q
for the quarter ended March 31, 2021, formatted in Inline XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets as of March 31, 2021 (unaudited) and December 31, 2020 (audited), (ii) Condensed Consolidated Statements of Operations (unaudited) for the three months ended March 31, 2021 and 2020, (iii) Condensed Consolidated Statements of Comprehensive Loss (unaudited) for the three months ended March 31, 2021 and 2020, (iv) Condensed Consolidated Statements of Stockholders’ Equity (unaudited) for the three months ended March 31, 2021 and 2020, (v) Condensed Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2021 and 2020, and (vi) Notes to Condensed Consolidated Financial Statements (unaudited).
|
X | ||||||||||||||||
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | X |
INTRA-CELLULAR THERAPIES, INC.
|
||||||
Date: May 10, 2021
|
By:
|
/s/ Sharon Mates, Ph.D.
|
||||
Sharon Mates, Ph.D.
|
||||||
Chairman, President and Chief Executive Officer
|
||||||
Date: May 10, 2021
|
By:
|
/s/ Lawrence J. Hineline
|
||||
Lawrence J. Hineline
|
||||||
Senior Vice President of Finance and Chief Financial Officer
|
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