Delaware
|
61-1009366
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer Identification No.)
|
Title of each class
|
|
Trading Symbol
|
|
Name of each exchange on which registered
|
Common Stock, $0.01 par value
|
|
IMMU
|
|
Nasdaq Stock Market LLC
|
|
|||
|
|||
|
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||
|
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||
|
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||
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|
|
ITEM 1.
|
FINANCIAL STATEMENTS (Unaudited)
|
|
March 31,
2020 |
|
December 31,
2019 |
||||
ASSETS
|
|
|
|
||||
Current Assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
536,295
|
|
|
$
|
608,628
|
|
Marketable securities
|
4,325
|
|
|
4,550
|
|
||
Accounts receivable, net of allowances of $0 at March 31, 2020 and December 31, 2019
|
—
|
|
|
295
|
|
||
Prepaid expenses
|
17,315
|
|
|
21,818
|
|
||
Other current assets
|
3,788
|
|
|
3,413
|
|
||
Total current assets
|
561,723
|
|
|
638,704
|
|
||
Property and equipment, net of accumulated depreciation and amortization of $8,907 and $7,925 at March 31, 2020 and December 31, 2019, respectively
|
32,150
|
|
|
32,762
|
|
||
Other long-term assets
|
233
|
|
|
256
|
|
||
Total Assets
|
$
|
594,106
|
|
|
$
|
671,722
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
||||
Current Liabilities:
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
59,268
|
|
|
$
|
60,860
|
|
Liability related to sale of future royalties - current
|
7,491
|
|
|
3,455
|
|
||
Lease liability - current
|
346
|
|
|
337
|
|
||
Convertible senior notes, net
|
—
|
|
|
7,106
|
|
||
Total current liabilities
|
67,105
|
|
|
71,758
|
|
||
Liability related to sale of future royalties - non-current
|
267,215
|
|
|
257,769
|
|
||
Deferred revenues
|
65,000
|
|
|
65,000
|
|
||
Lease liability - non-current
|
9,875
|
|
|
9,965
|
|
||
Total Liabilities
|
409,195
|
|
|
404,492
|
|
||
Commitments and Contingencies (Note 11)
|
|
|
|
|
|
||
Stockholders' Equity:
|
|
|
|
||||
Convertible preferred stock, $0.01 par value; authorized 10,000,000 shares; no shares issued and outstanding at March 31, 2020 and December 31, 2019
|
—
|
|
|
—
|
|
||
Common stock, $0.01 par value; authorized 250,000,000 shares; issued 213,929,505 shares and outstanding 213,809,884 shares at March 31, 2020; issued 212,529,313 shares and outstanding 212,409,692 shares at December 31, 2019
|
2,139
|
|
|
2,125
|
|
||
Capital contributed in excess of par
|
1,590,185
|
|
|
1,579,205
|
|
||
Treasury stock, at cost: 119,621 shares at March 31, 2020 and December 31, 2019
|
(2,095
|
)
|
|
(2,095
|
)
|
||
Accumulated deficit
|
(1,403,453
|
)
|
|
(1,310,406
|
)
|
||
Accumulated other comprehensive loss
|
(802
|
)
|
|
(568
|
)
|
||
Total Immunomedics, Inc. stockholders' equity
|
185,974
|
|
|
268,261
|
|
||
Noncontrolling interest in subsidiary
|
(1,063
|
)
|
|
(1,031
|
)
|
||
Total Stockholders' Equity
|
184,911
|
|
|
267,230
|
|
||
Total Liabilities and Stockholders' Equity
|
$
|
594,106
|
|
|
$
|
671,722
|
|
|
Three Months Ended
|
||||||
|
March 31,
|
||||||
|
2020
|
|
2019
|
||||
|
|
|
|
||||
Revenues
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
||||
Costs and Expenses:
|
|
|
|
||||
Research and development
|
62,428
|
|
|
58,172
|
|
||
Sales and marketing
|
8,067
|
|
|
7,881
|
|
||
General and administrative
|
11,473
|
|
|
13,595
|
|
||
Total costs and expenses
|
81,968
|
|
|
79,648
|
|
||
Operating loss
|
(81,968
|
)
|
|
(79,648
|
)
|
||
Interest expense
|
(13,538
|
)
|
|
(9,959
|
)
|
||
Interest and other income
|
2,427
|
|
|
2,203
|
|
||
Loss before income tax
|
(93,079
|
)
|
|
(87,404
|
)
|
||
Income tax expense
|
—
|
|
|
—
|
|
||
Net loss
|
$
|
(93,079
|
)
|
|
$
|
(87,404
|
)
|
Net loss attributable to noncontrolling interest
|
(32
|
)
|
|
(67
|
)
|
||
Net loss attributable to Immunomedics, Inc. stockholders
|
$
|
(93,047
|
)
|
|
$
|
(87,337
|
)
|
Loss per common share attributable to Immunomedics, Inc. stockholders (basic and diluted):
|
(0.44
|
)
|
|
(0.46
|
)
|
||
Weighted average shares used to calculate loss per common share (basic and diluted):
|
213,247
|
|
|
191,052
|
|
||
Other comprehensive loss, net of tax:
|
|
|
|
||||
Foreign currency translation adjustments
|
(9
|
)
|
|
(9
|
)
|
||
Unrealized loss on securities available for sale
|
(225
|
)
|
|
(200
|
)
|
||
Other comprehensive loss, net of tax:
|
(234
|
)
|
|
(209
|
)
|
||
Comprehensive loss
|
(93,313
|
)
|
|
(87,613
|
)
|
||
Comprehensive loss attributable to noncontrolling interest
|
(32
|
)
|
|
(67
|
)
|
||
Comprehensive loss attributable to Immunomedics, Inc. stockholders
|
$
|
(93,281
|
)
|
|
$
|
(87,546
|
)
|
|
Immunomedics, Inc. Stockholders' Equity
|
|
|
|
|
||||||||||||||||||||||||||||||||
|
Convertible Preferred Stock
|
|
|
|
|
|
Capital Contributed in Excess of Par
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
|
|
|
||||||||||||||||||||
|
|
Common Stock
|
|
|
Treasury Stock
|
|
Accumulated Deficit
|
|
|
Noncontrolling Interest
|
|
|
|||||||||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
Total
|
|||||||||||||||||||||||
Three Months Ended March 31, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||
Balance at December 31, 2019
|
—
|
|
|
$
|
—
|
|
|
212,529
|
|
|
$
|
2,125
|
|
|
$
|
1,579,205
|
|
|
$
|
(2,095
|
)
|
|
$
|
(1,310,406
|
)
|
|
$
|
(568
|
)
|
|
$
|
(1,031
|
)
|
|
$
|
267,230
|
|
Exercise of stock options, net
|
—
|
|
|
—
|
|
|
7
|
|
|
—
|
|
|
32
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
32
|
|
||||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,848
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,848
|
|
||||||||
Issuance of common stock due to debt conversion
|
—
|
|
|
—
|
|
|
1,393
|
|
|
$
|
14
|
|
|
7,100
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,114
|
|
|||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(234
|
)
|
|
—
|
|
|
(234
|
)
|
||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(93,047
|
)
|
|
—
|
|
|
(32
|
)
|
|
(93,079
|
)
|
||||||||
Balance at March 31, 2020
|
—
|
|
|
$
|
—
|
|
|
213,929
|
|
|
$
|
2,139
|
|
|
$
|
1,590,185
|
|
|
$
|
(2,095
|
)
|
|
$
|
(1,403,453
|
)
|
|
$
|
(802
|
)
|
|
$
|
(1,063
|
)
|
|
$
|
184,911
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||
Three Months Ended March 31, 2019:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||
Balance at December 31, 2018
|
—
|
|
|
$
|
—
|
|
|
190,446
|
|
|
$
|
1,905
|
|
|
$
|
1,219,237
|
|
|
$
|
(824
|
)
|
|
$
|
(953,216
|
)
|
|
$
|
(351
|
)
|
|
$
|
(902
|
)
|
|
$
|
265,849
|
|
Exercise of stock options, net
|
—
|
|
|
—
|
|
|
1,063
|
|
|
10
|
|
|
3,086
|
|
|
(1,271
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,825
|
|
||||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,743
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,743
|
|
||||||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(209
|
)
|
|
—
|
|
|
(209
|
)
|
||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(87,337
|
)
|
|
—
|
|
|
(67
|
)
|
|
(87,404
|
)
|
||||||||
Balance at March 31, 2019
|
—
|
|
|
$
|
—
|
|
|
191,509
|
|
|
$
|
1,915
|
|
|
$
|
1,224,066
|
|
|
$
|
(2,095
|
)
|
|
$
|
(1,040,553
|
)
|
|
$
|
(560
|
)
|
|
$
|
(969
|
)
|
|
$
|
181,804
|
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Cash flows from operating activities:
|
|
|
|
|
|
||
Net loss
|
$
|
(93,079
|
)
|
|
$
|
(87,404
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
960
|
|
|
804
|
|
||
Loss on disposal of property and equipment
|
87
|
|
|
—
|
|
||
Interest on non-recourse debt
|
13,482
|
|
|
9,962
|
|
||
Amortization of debt issuance costs
|
8
|
|
|
13
|
|
||
Non-cash lease expense
|
70
|
|
|
64
|
|
||
Non-cash expense related to stock-based compensation
|
3,848
|
|
|
1,743
|
|
||
Changes in other operating assets and liabilities
|
2,751
|
|
|
20,141
|
|
||
Net cash used in operating activities
|
(71,873
|
)
|
|
(54,677
|
)
|
||
Cash flows from investing activities
|
|
|
|
||||
Purchases of property and equipment
|
(473
|
)
|
|
(2,064
|
)
|
||
Net cash used in investing activities
|
(473
|
)
|
|
(2,064
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Exercise of stock options, net
|
32
|
|
|
1,825
|
|
||
Net cash provided by financing activities
|
32
|
|
|
1,825
|
|
||
Effect of changes in exchange rates on cash, cash equivalents and restricted cash
|
(19
|
)
|
|
(9
|
)
|
||
Net decrease in cash, cash equivalents and restricted cash
|
(72,333
|
)
|
|
(54,925
|
)
|
||
Cash, cash equivalents and restricted cash beginning of period
|
612,041
|
|
|
494,173
|
|
||
Cash, cash equivalents and restricted cash end of period
|
$
|
539,708
|
|
|
$
|
439,248
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
Interest paid
|
$
|
169
|
|
|
$
|
169
|
|
Schedule for non-cash investing and financing activities:
|
|
|
|
||||
Accrued capital expenditures
|
$
|
132
|
|
|
$
|
3,140
|
|
Shares received in cashless exercise
|
$
|
—
|
|
|
$
|
1,271
|
|
Issuance of common stock due to debt conversion
|
$
|
7,114
|
|
|
$
|
—
|
|
|
March 31, 2020
|
|
March 31, 2019
|
||||
Cash and cash equivalents
|
$
|
536,295
|
|
|
$
|
437,935
|
|
Restricted cash in other current assets
|
3,413
|
|
|
1,313
|
|
||
Total cash, cash equivalents and restricted cash
|
$
|
539,708
|
|
|
$
|
439,248
|
|
|
|
|
|
||||
Supplemental cash flow information related to leases for the three months ended:
|
|
|
|
||||
Non-cash lease expense
|
$
|
70
|
|
|
$
|
64
|
|
Change in operating lease liabilities
|
$
|
81
|
|
|
$
|
37
|
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gain
|
|
Gross
Unrealized
(Loss)
|
|
Fair Value
|
||||||||
U.S. Government Sponsored Agencies
|
$
|
4,941
|
|
|
$
|
—
|
|
|
$
|
(616
|
)
|
|
$
|
4,325
|
|
|
Fair Value
|
|
Net Carrying
Amount
|
||||
Due after one year through five years
|
$
|
4,325
|
|
|
$
|
4,337
|
|
|
Amortized
Cost |
|
Gross
Unrealized Gain |
|
Gross
Unrealized (Loss) |
|
Fair Value
|
||||||||
U.S. Government Sponsored Agencies
|
$
|
4,941
|
|
|
$
|
—
|
|
|
$
|
(391
|
)
|
|
$
|
4,550
|
|
|
Fair Value
|
|
Net Carrying
Amount |
||||
Due after one year through five years
|
$
|
4,550
|
|
|
$
|
4,562
|
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Carrying value of liability related to sale of future royalties, beginning of the period
|
$
|
261,224
|
|
|
$
|
221,295
|
|
Interest expense recognized
|
13,482
|
|
|
9,962
|
|
||
Carrying value of liability related to sale of future royalties, end of period
|
$
|
274,706
|
|
|
$
|
231,257
|
|
|
Stock Options
|
|
RSUs
|
|
PSOs
|
|||
Equity awards outstanding, beginning of year
|
5,901
|
|
|
58
|
|
|
837
|
|
Changes during the year:
|
|
|
|
|
|
|||
Granted
|
1,429
|
|
|
100
|
|
|
—
|
|
Exercised
|
(7
|
)
|
|
—
|
|
|
—
|
|
Expired or forfeited
|
(281
|
)
|
|
—
|
|
|
(153
|
)
|
Equity awards outstanding, end of period
|
7,042
|
|
|
158
|
|
|
684
|
|
Stock Options
|
|
RSUs
|
|
PSOs
|
||||||
Unrecognized compensation cost
|
$
|
47,499
|
|
|
$
|
308
|
|
|
$
|
4,644
|
|
Expected weighted-average period in years of compensation cost to be recognized
|
3.1
|
|
|
1.9
|
|
|
0.7
|
|
|
(in thousands)
|
||||||||||||||
March 31, 2020
|
Level 1 (a)
|
|
Level 2 (b)
|
|
Level 3 (c)
|
|
Total
|
||||||||
Money Market Funds Note (d)
|
$
|
502,461
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
502,461
|
|
Marketable Securities:
|
|
|
|
|
|
|
|
|
|||||||
U.S. Government Sponsored Agencies
|
4,325
|
|
|
—
|
|
|
—
|
|
|
4,325
|
|
||||
Total
|
$
|
506,786
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
506,786
|
|
|
(in thousands)
|
||||||||||||||
December 31, 2019
|
Level 1 (a)
|
|
Level 2 (b)
|
|
Level 3 (c)
|
|
Total
|
||||||||
Money Market Funds Note (d)
|
$
|
550,788
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
550,788
|
|
Marketable Securities:
|
|
|
|
|
|
|
|
|
|||||||
U.S. Government Sponsored Agencies
|
4,550
|
|
|
—
|
|
|
—
|
|
|
4,550
|
|
||||
Total
|
$
|
555,338
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
555,338
|
|
|
As of March 31, 2020
|
|
As of December 31, 2019
|
||||||||||||
|
Carrying Amount
|
|
Estimated Fair Value
|
|
Carrying Amount
|
|
Estimated Fair Value
|
||||||||
|
|
|
|
||||||||||||
Convertible Senior Notes
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,106
|
|
|
$
|
28,900
|
|
|
Fair Value
(in thousands)
|
Valuation Technique
|
Unobservable Input
|
Range
|
Weighted Average
|
Liability related to the sale of future royalties
|
$274,706
|
Discounted cash flow
|
Discount rate
|
16% - 26%
|
19%
|
|
|
|
Future royalty payments
|
2020 to 2036
|
|
|
Currency
Translation
Adjustments
|
|
Net Unrealized Losses on Available-
for-Sale Securities
|
|
Accumulated Other
Comprehensive
Loss
|
||||||
Balance, December 31, 2018
|
$
|
(347
|
)
|
|
$
|
(4
|
)
|
|
$
|
(351
|
)
|
Other comprehensive loss before reclassifications
|
(9
|
)
|
|
(200
|
)
|
|
(209
|
)
|
|||
Net current-period other comprehensive loss
|
$
|
(9
|
)
|
|
$
|
(200
|
)
|
|
$
|
(209
|
)
|
Balance, March 31, 2019
|
$
|
(356
|
)
|
|
$
|
(204
|
)
|
|
$
|
(560
|
)
|
|
|
|
|
|
|
||||||
Balance, December 31, 2019
|
$
|
(173
|
)
|
|
$
|
(395
|
)
|
|
$
|
(568
|
)
|
Other comprehensive loss before reclassifications
|
(9
|
)
|
|
(225
|
)
|
|
(234
|
)
|
|||
Net current-period other comprehensive loss
|
(9
|
)
|
|
(225
|
)
|
|
(234
|
)
|
|||
Balance, March 31, 2020
|
$
|
(182
|
)
|
|
$
|
(620
|
)
|
|
$
|
(802
|
)
|
•
|
the time and expense required for us to comply with all applicable federal, state and foreign legal requirements, including, without limitation, our receipt of the necessary approvals of the FDA (which receipt is uncertain);
|
•
|
the time and expense required for us to establish and maintain compliant operations for commercial manufacturing, sale, and distribution of products under FDA and healthcare law requirements, and risks of non-compliance;
|
•
|
we may be unable to obtain additional capital through strategic collaborations, licensing, or potential private and public capital markets financings, including the use of the ATM Agreement, in order to continue our research and secure regulatory approval of and market our lead drug candidate;
|
•
|
challenges based on the type of therapeutic compound under investigation and nature of the disease in connection with which the compound is being studied;
|
•
|
our ability, as well as the ability of our partners, to conduct and complete clinical trials on a timely basis, including as a result of any impacts to current or future trials due to COVID-19 pandemic;
|
•
|
the ability to provide and maintain an adequate clinical and commercial supply, including through contract manufacturer and vendor relationships;
|
•
|
the financial resources available to us during any particular period; and
|
•
|
many other factors associated with the commercial development of therapeutic products outside of our control.
|
|
|
|
|
|
($ in thousands)
|
||||||||
|
|
|
|
|
Increase/(Decrease)
|
||||||||
Three Months Ended March 31,
|
2020
|
|
2019
|
|
2020 vs 2019
|
||||||||
Research and development
|
$
|
62,428
|
|
|
$
|
58,172
|
|
|
$
|
4,256
|
|
|
7.3%
|
Sales and marketing
|
8,067
|
|
|
7,881
|
|
|
186
|
|
|
2.4%
|
|||
General and administrative
|
11,473
|
|
|
13,595
|
|
|
(2,122
|
)
|
|
(15.6)%
|
|||
Total costs and expenses
|
$
|
81,968
|
|
|
$
|
79,648
|
|
|
$
|
2,320
|
|
|
2.9%
|
|
|
|
|
|
|
|
|
•
|
the length of time required to recruit qualified patients for clinical trials;
|
•
|
the duration of patient follow-up in light of trial results;
|
•
|
the number of clinical sites required for trials; and
|
•
|
the number of patients that ultimately participate.
|
|
|
|
|
|
($ in thousands)
|
|||||||||
|
|
|
|
|
Increase/(Decrease)
|
|||||||||
Three Months Ended March 31,
|
2020
|
|
2019
|
|
2020 vs 2019
|
|||||||||
Labor costs
|
$
|
5,246
|
|
|
$
|
6,687
|
|
|
$
|
(1,441
|
)
|
|
(21.5
|
)%
|
Marketing and promotions
|
1,508
|
|
|
657
|
|
|
851
|
|
|
nm
|
|
|||
Consulting services
|
302
|
|
|
—
|
|
|
302
|
|
|
nm
|
|
|||
Other
|
1,011
|
|
|
537
|
|
|
474
|
|
|
88.3
|
%
|
|||
Total sales and marketing
|
$
|
8,067
|
|
|
$
|
7,881
|
|
|
$
|
186
|
|
|
2.4
|
%
|
nm- not meaningful
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in thousands)
|
|||||||||
|
|
|
|
|
(Decrease)/Increase
|
|||||||||
Three Months Ended March 31,
|
2020
|
|
2019
|
|
2020 vs 2019
|
|||||||||
Labor costs
|
$
|
4,843
|
|
|
$
|
6,813
|
|
|
$
|
(1,970
|
)
|
|
(28.9
|
)%
|
Legal and advisory fees
|
1,749
|
|
|
1,054
|
|
|
695
|
|
|
65.9
|
%
|
|||
Consulting services
|
1,118
|
|
|
2,146
|
|
|
(1,028
|
)
|
|
(47.9
|
)%
|
|||
Other
|
3,763
|
|
|
3,582
|
|
|
181
|
|
|
5.1
|
%
|
|||
Total general and administrative
|
$
|
11,473
|
|
|
$
|
13,595
|
|
|
$
|
(2,122
|
)
|
|
(15.6
|
)%
|
|
|
|
|
|
|
|
|
|
|
($ in thousands)
|
||||||
|
|
Three Months Ended March 31,
|
||||||
|
|
2020
|
|
2019
|
||||
Net cash used in operating activities
|
|
$
|
(71,873
|
)
|
|
$
|
(54,677
|
)
|
Net cash used in investing activities
|
|
(473
|
)
|
|
(2,064
|
)
|
||
Net cash provided by financing activities
|
|
32
|
|
|
1,825
|
|
•
|
later-stage clinical trials may raise safety or efficacy concerns not readily apparent in earlier trials or fail to meet the primary endpoint;
|
•
|
unforeseen difficulties in manufacturing the product candidate in compliance with all regulatory requirements and in the quantities needed to complete the trial which may become cost-prohibitive;
|
•
|
we or any of our collaboration partners may experience delays in obtaining, or be unable to obtain, agreement for the conduct of our clinical trials from the FDA, institutional review boards ("IRBs"), or other reviewing entities at clinical sites selected for participation in our clinical trials;
|
•
|
while underway, the continuation of clinical trials may be delayed, suspended or terminated due to modifications to the clinical trial’s protocols based on interim results obtained or changes required or conditions imposed by the FDA, an IRB, a data and safety monitoring board (“DSMB”), or any other regulatory authority;
|
•
|
our third-party contractors may fail to meet their contractual obligations to us in a timely manner;
|
•
|
the FDA or other regulatory authorities may impose a clinical hold, for example based on an inspection of the clinical trial operations or trial sites;
|
•
|
we or any of our collaboration partners may suspend or cease trials in our or their sole discretion;
|
•
|
during the long trial process alternative therapies may become available which make further development of the product candidate impracticable; and
|
•
|
if we are unable to obtain the additional capital we need to fund all of the clinical trials we foresee, we may be forced to cancel or otherwise curtail such trials and other studies.
|
•
|
upfront payments, milestone payments, and payments for limited amounts of our antibodies received from licensing partners;
|
•
|
proceeds from the public and private sale of our equity or debt securities; and
|
•
|
licenses and interest income from our investments.
|
•
|
the rate of progress of commercialization of Trodelvy in mTNBC and our ability to develop it for other cancers;
|
•
|
the rate at which we progress our research programs and the number of product candidates we have in preclinical and clinical development at any one time;
|
•
|
the cost of conducting clinical trials involving patients in the United States, Europe and possibly elsewhere;
|
•
|
our need to establish the manufacturing capabilities necessary to produce the quantities of our product candidates we project we will need;
|
•
|
the time and costs involved in obtaining FDA and foreign regulatory approvals;
|
•
|
the cost of first obtaining, and then defending, our patent claims and other intellectual property rights; and
|
•
|
our ability to enter into licensing and other collaborative agreements to help offset some of these costs.
|
•
|
the need to recruit, train, manage, and retain adequate numbers of effective sales and marketing personnel over a large geographic area;
|
•
|
the costs and time associated with the initial and ongoing training of sales and marketing personnel on legal and regulatory compliance matters and monitoring their actions;
|
•
|
the clinical indications for which the products are approved and the claims that we may make for the products;
|
•
|
limitations or warnings, including distribution or use restrictions, contained in the products’ approved labeling;
|
•
|
any distribution and use restrictions imposed by the FDA or to which we agree;
|
•
|
our ability to appropriately market, detail, and distribute products in light of healthcare provider facility closures, quarantine, travel restrictions and other governmental restrictions caused by COVID-19;
|
•
|
understanding and training relevant personnel on the limitations on, and the transparency and reporting requirements applicable to, remuneration provided to actual and potential referral sources; and
|
•
|
liability for sales or marketing personnel who fail to comply with the applicable legal and regulatory requirements.
|
•
|
the timing of our receipt of marketing approvals, the terms of such approvals and the countries in which such approvals are obtained;
|
•
|
the safety, efficacy, reliability and ease of administration of our product candidates;
|
•
|
the prevalence and severity of undesirable side effects and adverse events;
|
•
|
the extent of the limitations or warnings required by the FDA or comparable regulatory authorities in other countries to be contained in the labeling of our product candidates;
|
•
|
the clinical indications for which our product candidates are approved;
|
•
|
the availability and perceived advantages of alternative therapies;
|
•
|
any publicity related to our product candidates or those of our competitors;
|
•
|
the quality and price of competing products;
|
•
|
our ability to obtain third-party payor coverage and sufficient reimbursement;
|
•
|
our ability to appropriately market, detail, and distribute products in light of healthcare provider facility closures, quarantine, travel restrictions and other governmental restrictions caused by COVID-19;
|
•
|
the willingness of patients to pay out of pocket in the absence of third-party payor coverage; and
|
•
|
the selling efforts and commitment of our commercialization collaborators.
|
•
|
the Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with the Secretary of the Department of Health and Human Services as a condition of Medicare Part B and Medicaid coverage of the manufacturer's outpatient drugs furnished to Medicaid patients. Effective in 2010, the ACA made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical manufacturers' rebate
|
•
|
the expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals beginning in April 2010 and by adding new mandatory eligibility categories for certain individuals with income at or below 133.0% of the federal poverty level beginning in 2014, thereby potentially increasing both the volume of sales and manufacturer's Medicaid rebate liability;
|
•
|
in order for a pharmaceutical product to receive federal reimbursement under the Medicare Part B and Medicaid programs or to be sold directly to United States government agencies, the manufacturer must extend discounts to entities eligible to participate in the 340B drug pricing program. The required 340B discount on a given product is calculated based on the AMP and Medicaid rebate amounts reported by the manufacturer. Effective in 2010, the ACA expanded the types of entities eligible to receive discounted 340B pricing, although, under the current state of the law, with the exception of children's hospitals, these newly eligible entities will not be eligible to receive discounted 340B pricing on orphan drugs when used for the orphan indication. In addition, as 340B drug pricing is determined based on AMP and Medicaid rebate data, the revisions to the Medicaid rebate formula and AMP definition described above could cause the required 340B discount to increase. Proposed guidance from the United States Department of Health and Human Services Health Resources and Services Administration, if adopted in its current form, may affect manufacturers' rights and liabilities in conducting audits and resolving disputes under the 340B program;
|
•
|
the ACA imposed a requirement on manufacturers of branded drugs to provide a 50% which increased to 70% on January 1, 2019, discount off the negotiated price of branded drugs dispensed to Medicare Part D patients in the coverage gap (i.e., the "donut hole");
|
•
|
the ACA imposed an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs, apportioned among these entities according to their market share in certain government healthcare programs, although this fee would not apply to sales of certain products approved exclusively for orphan indications;
|
•
|
the ACA implemented the Physician Payments Sunshine Act;
|
•
|
the ACA requires annual reporting of drug samples that manufacturers and distributors provide to physicians;
|
•
|
the ACA expanded healthcare fraud and abuse laws in the United States, including the False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for non-compliance;
|
•
|
the ACA established a licensing framework for follow-on biologics;
|
•
|
the ACA established the Patient-Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with the funding for such research. The research conducted by the Patient-Centered Outcomes Research Institute may affect the market for certain pharmaceutical products by influencing decisions relating to coverage and reimbursement rates; and
|
•
|
the ACA established the Center for Medicare & Medicaid Innovation within the Centers for Medicare & Medicaid Services ("Innovation Center"), to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending. The Innovation Center was funded through 2019, and funding will be automatically renewed for each 10-year budget window thereafter.
|
•
|
clinical development is a long, expensive and uncertain process; delay and failure can occur at any stage of our clinical trials;
|
•
|
our clinical trials are dependent on patient enrollment and regulatory approvals; we do not know whether our planned trials will begin on time, or at all, or will be completed on schedule, or at all;
|
•
|
the FDA or other regulatory authorities may not approve a clinical trial protocol or may place a clinical trial on hold;
|
•
|
we rely on third parties, such as consultants, contract research organizations, medical institutions, and clinical investigators, to conduct clinical trials for our drug candidates and if we or any of our third-party contractors fail to comply with applicable regulatory requirements, such as requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, European Medicines Agency ("EMA") or comparable foreign regulatory authorities may require us to perform additional clinical trials;
|
•
|
if the clinical development process is completed successfully, our ability to derive revenues from the sale of therapeutics will depend on our first obtaining FDA or other comparable foreign regulatory approvals, each of which is subject to unique risks and uncertainties;
|
•
|
there is no assurance that we will receive FDA or corollary foreign approval for any of our product candidates for any indication; we are subject to government regulation for the commercialization of our product candidates;
|
•
|
although we have received accelerated approval for Trodelvy in the United States, its continuing approval remains subject to the outcomes of our confirmatory Phase 3 clinical trial along with post-marketing requirements and commitments;
|
•
|
even if one or more of our product candidates does obtain approval, regulatory authorities may approve such product candidate for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate;
|
•
|
undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities;
|
•
|
later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with the regulatory requirements of FDA and other applicable United States and foreign regulatory authorities could subject us to administrative or judicially imposed sanctions;
|
•
|
although several of our product candidates have received orphan drug designation in the United States and the European Union ("EU"), for particular indications, we may not receive orphan drug exclusivity for any or all of those product candidates or indications upon approval, and even if we do obtain orphan drug exclusivity, that exclusivity may not effectively protect the product from competition; and
|
•
|
even if one or more of our product candidates is approved in the United States, it may not obtain the 12 years of exclusivity from biosimilars for which innovator biologics are eligible, and even if it does obtain such exclusivity, that exclusivity may not effectively protect the product from competition; the FDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our drug candidates, and if we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained; and we may be liable for contamination or other harm caused by hazardous materials used in the operations of our business.
|
•
|
The federal Anti-Kickback Statute, which prohibits, among other things, persons and entities including pharmaceutical manufacturers from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, overtly or covertly, in case or in kind, to induce or reward, or in return for, or either the referral of an individual for, or the purchase, lease, order or recommendation of, an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare or Medicaid programs. This statute has interpreted broadly to apply to, among other things, arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other hand. The term "remuneration" expressly includes kickbacks, bribes or rebates and also has been broadly interpreted to include anything of value, including, for example, gifts, discounts, waivers of payment, ownership interest and providing anything at less than its fair market value. There are a number of statutory exceptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory sanctions; however, the exceptions and safe harbors are drawn narrowly, and practices that do not fit squarely within an exception or safe harbor may be subject to scrutiny. The failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the federal Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Our practices may not meet all of the criteria for safe harbor protection from federal Anti-Kickback Statute liability in all cases. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or
|
•
|
Federal enforcement agencies and private whistleblowers recently have shown interest in pharmaceutical companies’ product and patient assistance programs ("PAPs"), including reimbursement support, co-pay support, nursing, adherence and educational services, referrals to other providers, donations to independent patient assistance charities, and relationships with specialty pharmacies. Co-pay assistance programs are intended to assist qualified patients with private insurance with any out-of-pocket financial obligations but must exclude any government healthcare program beneficiaries. Several investigations into patient assistance practices have resulted in significant civil and criminal settlements. Recently, the HHS-Office of the Inspector General has released several industry guidance documents, special bulletins, and advisory opinions addressing PAPs. Failure to implement certain measures and safeguards may be found by government agencies to courts to be evidence of intent to induce the purchase of drugs paid for by federal programs, in violations of the Anti-Kickback Statute. PAPs have also been the subject of recent Congressional review.
|
•
|
The federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claims Act, which prohibits individuals or entities from, among other things, knowingly presenting, or causing to be presented, claims for payment to, or approval by, the federal government that are false, fictitious or fraudulent or knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes "any request or demand" for money or property presented to the federal government. Although we do not submit claims directly to payors, manufacturers can be held liable under these laws if they are deemed to "cause" the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers, promoting a product off-label, marketing products of sub-standard quality, or, as noted above, paying a kickback that results in a claim for items or services in violation of the Anti-Kickback Statue. In addition, our activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state and third-party reimbursement for our products, and the sale and marketing of our products, are subject to scrutiny under this law. For example, several pharmaceutical and other healthcare companies have faced enforcement actions under these laws for allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. The False Claims Act also permits a private individual acting as a "whistleblower" to bring actions on behalf of the federal government alleging violations of the False Claims Act and to share in any monetary recovery. In addition, certain marketing practices, including off-label promotion, may also implicate the False Claims Act. Although the False Claims Act is a civil statute, conduct that results in a False Claims Act violation may also implicate various federal criminal statutes.
|
•
|
The Federal Health Insurance Portability and Accountability Act of 1996, ("HIPAA"), which imposes criminal and civil liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation.
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, ("HITECH"), and their respective implementing regulations, including the Final Omnibus Rule published on January 25, 2013, impose, among other things, obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information held by certain healthcare providers, health plans and healthcare clearinghouses, known as covered entities, and business associates. Among other things, HITECH made certain aspects of HIPAA's rules (notably the Security Rule) directly applicable to business associates - independent contractors or agents of covered entities that receive or obtain individually identifiable health information in connection with providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal court to enforce the federal HIPAA laws and seek attorney's fees and costs associated with pursuing federal civil actions. The Department of Health and Human Services Office of Civil Rights, or ("OCR"), has increased its focus on compliance and continues to train state attorneys general
|
•
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The federal physician payment transparency requirements, sometimes referred to as the "Physician Payments Sunshine Act," created under the United States Patient Protection and Affordable Care Act of 2010, as amended, or the ACA, and its implementing regulations, which requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the State Children's Health Insurance Program (with certain exceptions) to annually report to HHS, information related to certain payments or other transfers of value made or distributed to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. In 2022, the Sunshine Act will be extended to payments and transfers of value to physician assistants, nurse practitioners, and other mid-level practitioners (with reporting requirements going into effect in 2022 for payments made in 2021). In addition, Section 6004 of the ACA requires annual reporting of information about drug samples that manufacturers and authorized distributors provide to healthcare providers.
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On October 25, 2018, President Trump signed into law the “Substance Use-Disorder Prevention that Promoted Opioid Recovery and Treatment for Patients and Communities Act.” This law, in part (under a provision entitled “Fighting the Opioid Epidemic with Sunshine”), will extend the Sunshine Act to payments and transfers of value to physician assistants, nurse practitioners, and other mid-level healthcare providers (with reporting requirements going into effect in 2022 for payments made in 2021.
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According to the United States Federal Trade Commission, ("FTC"), failing to take appropriate steps to keep consumers' personal information secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act, or the FTCA, 15 USC § 45(a). The FTC expects a company's data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Medical data is considered sensitive data that merits stronger safeguards. The FTC's guidance for appropriately securing consumers' personal information is similar to what is required by the HIPAA Security Rule.
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To the extent we obtain coverage for our products by state Medicaid programs, we may be required to pay a rebate to each state Medicaid program for any covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program, and to comply with all Medicaid rebate requirements of the Omnibus Budget Reconciliation Act of 1990 and the Veterans Healthcare Act of 1992. Moreover, federal law requires that any company participating in the Medicaid Drug Rebate program also participate in the Public Health Service’s 340B Program, which impose additional reporting requirements and price concessions. Manufacturer compliance with 340B Program requirements can be costly. In addition, if our products are made available to authorized users of the Federal Supply Schedule of the General Services Administration or to low income patients of certain hospitals, additional laws and requirements may apply.
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Analogous state laws and regulations, such as state anti-kickback and false claims laws,, and other states laws addressing the pharmaceutical and healthcare industries, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and in some cases that may apply regardless of payor, i.e., even if reimbursement is not available; some state laws require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines (the PhRMA Code) and the relevant compliance program guidance promulgated by the federal government (HHS-OIG) in addition to requiring drug manufacturers to report pricing and marketing information, including, among other things, information related to gifts, payments, or other remuneration to physicians and other healthcare providers, state and local laws that require the registration of pharmaceutical sales representatives, and state laws governing the privacy and security of health information and the use of prescriber-identifiable data in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. For example, California enacted legislation - the California Consumer Privacy Act (“CCPA”) - which goes into effect January 1, 2020. The CCPA, among other things, created new data privacy obligations for covered companies and provided new privacy rights to California residents, including the right to opt out of certain disclosures of their information. The CCPA also created a private right of action with statutory damages for certain data breaches, thereby potentially increasing risks associated with a data breach. The California Attorney General has issued clarifying regulations. Although the law includes limited exceptions, including for certain information collected as part of clinical trials as specified in the law and for protected health information collected by covered entities or business associates subject to HIPAA as specified in the law, it may regulate or impact our processing of personal information
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requiring the dedication of a substantial portion of our existing cash and marketable securities balances and, if available, future cash flow from operations to service our indebtedness, thereby reducing the amount of our expected cash flow available for other purposes, including capital expenditures;
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increasing our vulnerability to general adverse economic and industry conditions;
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limiting our ability to obtain additional financing;
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limiting our ability to sell assets if deemed necessary;
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limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and
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placing us at a possible competitive disadvantage to less leveraged competitors and competitors that have better access to capital resources.
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Announcements by us, any collaboration partners, any future alliance partners or our competitors of pre-clinical studies and clinical trial results, regulatory developments, technological innovations or new therapeutic products, product sales, new products or product candidates and product development timelines;
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The formation or termination of corporate alliances;
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Developments in patent or other proprietary rights by us or our respective competitors, including litigation;
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Developments or disputes concerning our patent or other proprietary rights, and the issuance of patents in our field of business to others;
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Government regulatory action;
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Period-to-period fluctuations in the results of our operations; and
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Developments and market conditions for emerging growth companies and biopharmaceutical companies, in general.
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IMMUNOMEDICS, INC.
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May 6, 2020
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/s/ Harout Semerjian
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Harout Semerjian
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Chief Executive Officer (Principal Executive Officer)
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May 6, 2020
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/s/ Usama Malik
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Usama Malik
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Chief Financial Officer (Principal Financial Officer)
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Exhibit Number
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Description of Document
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10.41*
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10.42*
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10.43*+
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10.44*
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10.45*
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10.46*+
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31.1*
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31.2*
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32.1**
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32.2**
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101*
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The following financial information from this Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, formatted in iXBRL (Inline eXtensible Business Reporting Language) filed electronically herewith: (i) the Condensed Consolidated Balance Sheets as of March 31, 2020 (unaudited) and December 31, 2019; (ii) the Condensed Consolidated Statements of Comprehensive Loss (unaudited) for the three months ended March 31, 2020 and 2019; (iii) the Condensed Consolidated Statements of Changes in Stockholders' Equity (unaudited) for the three months ended March 31, 2020 and 2019; (iv) the Condensed Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2020 and 2019; and, (v) the Notes to Unaudited Condensed Consolidated Financial Statements.
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104*
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The cover page of this Quarterly Report on Form 10-Q for the quarter ended March 31, 2020,
formatted in Inline XBRL, included in Exhibit 101 Inline XBRL Document Set.
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If your Service with the Company is terminated during the period commencing six (6) months prior to and one year following a Change of Control either (i) by the Company or its successor without Cause, or (ii) by you for Good Reason, the Options that had not yet become exercisable as of the date of termination will immediately become 100% vested and exercisable.
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"Change of Control","Cause", and "Good Reason" have the meaning given those terms in your Employment Agreement.
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Enclosures: Incentive Stock Option Agreement
Prospectus for the 2014 Long-Term Incentive Plan
Exercise Form
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(a)
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25% of the Options become vested and exercisable on the first anniversary of the Vesting Commencement Date, and
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(b)
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6.25% of the Options become vested and exercisable on the date three months after the Vesting Commencement Date and on such date every three months thereafter, through the fourth anniversary of the Vesting Commencement Date.
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If your Service with the Company is terminated before a Change of Control either (i) by the Company without Cause, (ii) by you for Good Reason, or (iii) following a Company notice to you of a non-renewal of the Employment Period upon the expiration of the then-current Employment Period, the portion (if any) of the Options that were not vested and exercisable when your Service with the Company is terminated shall immediately become vested and exercisable as if your Service with the Company had continued for six (6) months following such termination, and the remaining portion (if any) of the Options that were not vested and exercisable when your Service with the Company is terminated shall be cancelled as of the date of termination.
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If your Service with the Company is terminated on or within one year following a Change of Control either (i) by the Company or its successor without Cause, (ii) by you for Good Reason, or (iii) following a Company notice to you of a non-renewal of the Employment Period prior to the expiration of the then-current Employment Period, all Options that were not vested and exercisable when your Service with the Company is terminated shall become 100% vested and exercisable as of the date of termination.
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“Change of Control”, “Cause”, “Good Reason”, and “Employment Period” have the meaning given those terms in your Employment Agreement.
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Enclosures: Nonqualified Stock Option Agreement
Prospectus for the 2014 Long-Term
Incentive Plan
Exercise Form
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(i)
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notice, in such manner and form as the Administrator may require from time to time, specifying the number of Shares to be purchased under the Options;
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(ii)
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full payment of the Exercise Price for the Shares or properly executed, irrevocable instructions, in such manner and form as the Administrator may require from time to time, to effectuate a broker-assisted cashless exercise, each in accordance with Section 2(d) of this Agreement; and
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(iii)
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full payment of applicable withholding taxes pursuant to Section 7 of this Agreement.
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(i)
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delivery of cash, certified or cashier’s check, money order or other cash equivalent acceptable to the Administrator in its discretion;
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(ii)
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a broker-assisted cashless exercise in accordance with Regulation T of the Board of Governors of the Federal Reserve System through a brokerage firm designated or approved by the Administrator;
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(iii)
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subject to such limits as the Administrator may impose from time to time, tender (via actual delivery or attestation) to the Company of other shares of Common Stock of the Company which have a Fair Market Value on the date of tender equal to the Exercise Price;
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(iv)
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subject to such limits as the Administrator may impose from time to time, net share settlement;
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(v)
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any other method approved by the Administrator; or
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(vi)
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any combination of the foregoing.
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(i)
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(i) the expiration of 90 days following such cessation, if your Service ceases on account of (1) your termination by the Company other than a discharge for Cause, or (2) your voluntary termination other than for Total and Permanent Disability or death;
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(ii)
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the expiration of 12 months following such cessation, if your Service ceases on account of your Total and Permanent Disability or death;
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(iii)
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the expiration of 12 months following your death, if your death occurs during the periods described in clauses (i) or (ii) of this Section 3(b), as applicable; or
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(iv)
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the Expiration Date.
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(d)
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Change in Status. In the event that your Service is with a business, trade or entity that, after the Grant Date, ceases for any reason to be part or an Affiliate of the Company, your Service will be deemed to have terminated for purposes of this Section 3 upon such cessation if your Service does not continue uninterrupted immediately thereafter with the Company or an Affiliate of the Company.
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(a)
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At the time the Options are exercised, in whole or in part, or at any time thereafter as requested by the Company, you hereby authorize withholding from payroll or any other payment of any kind due to you and otherwise agree to make adequate provision for foreign, federal, state and local taxes required by law to be withheld, if any, which arise in connection with the Options. The Company may require you to make a cash payment to cover any withholding tax obligation as a condition of exercise of the Options or issuance of share certificates representing Shares.
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(b)
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The Administrator may, in its sole discretion, permit you to satisfy, in whole or in part, any withholding tax obligation which may arise in connection with the Options either by
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(a)
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50% of the RSUs shall vest on the first (1st) anniversary of the Vesting Commencement Date, and
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(b)
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the remaining 50% of RSUs shall vest on the second (2nd) anniversary of the Vesting Commencement Date.
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If your Service with the Company is terminated before a Change of Control either (i) by the Company without Cause, (ii) by you with Good Reason, or (iii) following a Company notice to you of a non-renewal of the Employment Period upon the expiration of the then-current Employment Period, the unvested portion (if any) of the RSUs shall immediately vest as if your Service with the Company had continued for six (6) months following such termination and be promptly settled as of the date of termination, and the remaining unvested portion (if any) of the RSUs shall be cancelled as of the date of termination.
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If your Service with the Company is terminated on or within one year following a Change of Control either (i) by the Company or its successor without Cause, (ii) by you for Good Reason, or (iii) following a Company notice to you of a non-renewal of the Employment Period prior to the expiration of the then-current Employment Period, all unvested RSUs shall become fully vested and be promptly settled as of the date of termination subject to earlier termination under Section 11 of the Plan.
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“Change of Control”, “Cause”, “Good Reason”, and “Employment Period” have the meaning given those terms in your Employment Agreement.
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(a)
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One-third (1/3) of the PSUs shall vest upon the Company achieving gross revenue of not less than [***] from sales of the Company’s sacituzumab govitecan (“SG”) drug for a fiscal quarter on the date such gross revenue is filed in the Company’s quarterly (10-Q) or annual (10-K) income statement, as applicable, with the U.S. Securities and Exchange Commission,
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(b)
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One-third (1/3) of the PSUs shall vest upon the Company achieving gross revenue of not less than [***] from sales of the Company’s SG drug for a fiscal quarter on the date such gross revenue is filed in the Company’s quarterly (10-Q) or annual (10-K) income statement, as applicable, with the U.S. Securities and Exchange Commission, and
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(c)
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One-third (1/3) of the PSUs shall vest on the date the Company’s SG drug receives approval in 2nd Indication overall in accordance with the U.S. Food and Drug Administration
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If your Service with the Company is terminated on or within one year following a Change of Control either (i) by the Company or its successor without Cause, (ii) by you for Good Reason, or (iii) following a Company notice to you of a non-renewal of the Employment Period prior to the expiration of the then-current Employment Period, all unvested PSUs shall become fully vested and be promptly settled as of the date of termination.
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“Change of Control”, “Cause”, “Good Reason”, and “Employment Period” have the meaning given those terms in your Employment Agreement.
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/s/ Harout Semerjian
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Harout Semerjian
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Principal Executive Officer
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/s/ Usama Malik
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Usama Malik
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Principal Financial Officer
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Dated: May 6, 2020
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/s/ Harout Semerjian
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Harout Semerjian
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Principal Executive Officer and
Chief Executive Officer
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Dated: May 6, 2020
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/s/ Usama Malik
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Usama Malik
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Principal Financial Officer and
Chief Financial Officer
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