|
Delaware
(State or other jurisdiction of incorporation or organization)
|
|
42-1560076
(I.R.S. Employer Identification No.)
|
1900 Powell Street, Suite 1000
Emeryville, CA
(Address of principal executive offices)
|
|
94608
(Zip Code)
|
Title of each class
Common Stock, par value $0.001 per share
|
|
Trading Symbol(s)
ADMS
|
|
Name of each exchange on which registered
The Nasdaq Global Market
|
Large accelerated filer
|
¨
|
|
Accelerated filer
|
x
|
Non-accelerated filer
|
¨
|
|
Smaller reporting company
|
x
|
|
|
|
Emerging growth company
|
x
|
|
|
|
|
Page
|
|
|||
|
|
|
|
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|||
|
|||
|
|||
|
|
|
|
|
|||
|
|
|
|
|
|||
|
|||
|
|||
|
|||
|
|||
|
|||
|
|||
|
|
|
|
|
June 30,
2019 |
|
December 31,
2018 |
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
62,737
|
|
|
$
|
56,605
|
|
Available-for-sale securities
|
105,910
|
|
|
154,265
|
|
||
Accounts receivable, net
|
6,411
|
|
|
5,511
|
|
||
Inventory
|
5,653
|
|
|
5,121
|
|
||
Prepaid expenses and other current assets
|
6,296
|
|
|
6,871
|
|
||
Total current assets
|
187,007
|
|
|
228,373
|
|
||
Property and equipment, net
|
2,971
|
|
|
3,652
|
|
||
Operating lease right-of-use assets
|
7,592
|
|
|
—
|
|
||
Prepaid expenses and other non-current assets
|
2,661
|
|
|
2,789
|
|
||
Total assets
|
$
|
200,231
|
|
|
$
|
234,814
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
6,351
|
|
|
$
|
6,570
|
|
Accrued liabilities
|
16,258
|
|
|
15,530
|
|
||
Current portion of long-term debt
|
1,585
|
|
|
1,664
|
|
||
Other current liabilities
|
1,523
|
|
|
512
|
|
||
Total current liabilities
|
25,717
|
|
|
24,276
|
|
||
Long-term debt
|
121,943
|
|
|
117,457
|
|
||
Long-term portion of operating lease liabilities
|
8,367
|
|
|
—
|
|
||
Other non-current liabilities
|
1,501
|
|
|
3,196
|
|
||
Total liabilities
|
157,528
|
|
|
144,929
|
|
||
Commitments and Contingencies (Note 8)
|
|
|
|
||||
Stockholders’ equity
|
|
|
|
||||
Preferred stock, $0.001 par value — 5,000,000 shares authorized, and zero shares issued and outstanding at June 30, 2019 and December 31, 2018
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value — 100,000,000 shares authorized,
27,710,207
and 27,434,358 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively
|
32
|
|
|
32
|
|
||
Additional paid-in capital
|
439,795
|
|
|
432,815
|
|
||
Accumulated other comprehensive gain (loss)
|
103
|
|
|
(264
|
)
|
||
Accumulated deficit
|
(397,227
|
)
|
|
(342,698
|
)
|
||
Total stockholders’ equity
|
42,703
|
|
|
89,885
|
|
||
Total liabilities and stockholders’ equity
|
$
|
200,231
|
|
|
$
|
234,814
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Revenues:
|
|
|
|
|
|
|
|
||||||||
Product sales
|
$
|
12,691
|
|
|
$
|
7,565
|
|
|
$
|
24,356
|
|
|
$
|
10,118
|
|
Costs and operating expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of product sales
|
685
|
|
|
73
|
|
|
1,098
|
|
|
98
|
|
||||
Research and development
|
8,598
|
|
|
9,806
|
|
|
18,812
|
|
|
16,994
|
|
||||
Selling, general and administrative, net
|
25,216
|
|
|
27,699
|
|
|
52,904
|
|
|
54,062
|
|
||||
Total costs and operating expenses
|
34,499
|
|
|
37,578
|
|
|
72,814
|
|
|
71,154
|
|
||||
Loss from operations
|
(21,808
|
)
|
|
(30,013
|
)
|
|
(48,458
|
)
|
|
(61,036
|
)
|
||||
Interest and other income, net
|
734
|
|
|
1,132
|
|
|
1,457
|
|
|
2,010
|
|
||||
Interest expense
|
(3,797
|
)
|
|
(5,112
|
)
|
|
(7,528
|
)
|
|
(9,938
|
)
|
||||
Net loss
|
$
|
(24,871
|
)
|
|
$
|
(33,993
|
)
|
|
$
|
(54,529
|
)
|
|
$
|
(68,964
|
)
|
Net loss per share, basic and diluted
|
$
|
(0.90
|
)
|
|
$
|
(1.26
|
)
|
|
$
|
(1.98
|
)
|
|
$
|
(2.61
|
)
|
Weighted average shares used in computing net loss per share, basic and diluted
|
27,579
|
|
|
27,040
|
|
|
27,516
|
|
|
26,454
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net loss
|
$
|
(24,871
|
)
|
|
$
|
(33,993
|
)
|
|
$
|
(54,529
|
)
|
|
$
|
(68,964
|
)
|
Unrealized gain (loss) on available-for-sale securities
|
137
|
|
|
(62
|
)
|
|
367
|
|
|
(258
|
)
|
||||
Comprehensive loss
|
$
|
(24,734
|
)
|
|
$
|
(34,055
|
)
|
|
$
|
(54,162
|
)
|
|
$
|
(69,222
|
)
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated Other Comprehensive Loss
|
|
Accumulated Deficit
|
|
Total Stockholders’ Equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balances at December 31, 2017
|
23,320,551
|
|
|
$
|
28
|
|
|
$
|
277,964
|
|
|
$
|
(167
|
)
|
|
$
|
(211,699
|
)
|
|
$
|
66,126
|
|
Issuance of common stock in conjunction with Secondary Offering, net of commissions and issuance costs
|
3,450,000
|
|
|
4
|
|
|
134,260
|
|
|
—
|
|
|
—
|
|
|
134,264
|
|
|||||
Exercise of stock options
|
136,154
|
|
|
—
|
|
|
590
|
|
|
—
|
|
|
—
|
|
|
590
|
|
|||||
Restricted stock units vested
|
51,309
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net unrealized loss on available-for-sale securities
|
—
|
|
|
—
|
|
|
—
|
|
|
(196
|
)
|
|
—
|
|
|
(196
|
)
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
3,790
|
|
|
—
|
|
|
—
|
|
|
3,790
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(34,971
|
)
|
|
(34,971
|
)
|
|||||
Balances at March 31, 2018
|
26,958,014
|
|
|
32
|
|
|
416,604
|
|
|
(363
|
)
|
|
(246,670
|
)
|
|
169,603
|
|
|||||
Issuance of common stock in conjunction with Secondary Offering, net of commissions and issuance costs
|
—
|
|
|
—
|
|
|
4
|
|
|
—
|
|
|
—
|
|
|
4
|
|
|||||
Exercise of stock options
|
169,124
|
|
|
—
|
|
|
1,943
|
|
|
—
|
|
|
—
|
|
|
1,943
|
|
|||||
Restricted stock units vested
|
22,687
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock issued under employee stock purchase plan
|
34,618
|
|
|
—
|
|
|
843
|
|
|
—
|
|
|
—
|
|
|
843
|
|
|||||
Net unrealized
loss
on available-for-sale securities
|
—
|
|
|
—
|
|
|
—
|
|
|
(62
|
)
|
|
—
|
|
|
(62
|
)
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
4,222
|
|
|
—
|
|
|
—
|
|
|
4,222
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(33,993
|
)
|
|
(33,993
|
)
|
|||||
Balances at June 30, 2018
|
27,184,443
|
|
|
$
|
32
|
|
|
$
|
423,616
|
|
|
$
|
(425
|
)
|
|
$
|
(280,663
|
)
|
|
$
|
142,560
|
|
Balances at December 31, 2018
|
27,434,358
|
|
|
$
|
32
|
|
|
$
|
432,815
|
|
|
$
|
(264
|
)
|
|
$
|
(342,698
|
)
|
|
$
|
89,885
|
|
Exercise of stock options
|
18,230
|
|
|
—
|
|
|
49
|
|
|
—
|
|
|
—
|
|
|
49
|
|
|||||
Restricted stock units vested
|
67,391
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net unrealized gain on available-for-sale securities
|
—
|
|
|
—
|
|
|
—
|
|
|
230
|
|
|
—
|
|
|
230
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
3,410
|
|
|
—
|
|
|
—
|
|
|
3,410
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(29,658
|
)
|
|
(29,658
|
)
|
|||||
Balances at March 31, 2019
|
27,519,979
|
|
|
32
|
|
|
436,274
|
|
|
(34
|
)
|
|
(372,356
|
)
|
|
63,916
|
|
|||||
Exercise of stock options
|
65,064
|
|
|
—
|
|
|
99
|
|
|
—
|
|
|
—
|
|
|
99
|
|
|||||
Restricted stock units vested
|
12,860
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock issued under employee stock purchase plan
|
112,304
|
|
|
—
|
|
|
449
|
|
|
—
|
|
|
—
|
|
|
449
|
|
|||||
Net unrealized
gain
on available-for-sale securities
|
—
|
|
|
—
|
|
|
—
|
|
|
137
|
|
|
—
|
|
|
137
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
2,973
|
|
|
—
|
|
|
—
|
|
|
2,973
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(24,871
|
)
|
|
(24,871
|
)
|
|||||
Balances at June 30, 2019
|
27,710,207
|
|
|
$
|
32
|
|
|
$
|
439,795
|
|
|
$
|
103
|
|
|
$
|
(397,227
|
)
|
|
$
|
42,703
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
June 30, |
||||||
|
2019
|
|
2018
|
||||
Cash flows from operating activities
|
|
|
|
||||
Net loss
|
$
|
(54,529
|
)
|
|
$
|
(68,964
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
||||
Depreciation
|
692
|
|
|
734
|
|
||
Stock-based compensation
|
6,323
|
|
|
7,890
|
|
||
Accretion of interest expense
|
7,528
|
|
|
9,938
|
|
||
Change in fair value of embedded derivative liability
|
149
|
|
|
44
|
|
||
Net accretion of discounts and amortization of premiums of available-for-sale securities
|
(675
|
)
|
|
(344
|
)
|
||
Changes in assets and liabilities
|
|
|
|
|
|
||
Accrued interest of available-for-sale securities
|
54
|
|
|
(234
|
)
|
||
Accounts receivable, net
|
(900
|
)
|
|
(3,045
|
)
|
||
Inventory
|
(524
|
)
|
|
(1,726
|
)
|
||
Prepaid expenses and other assets
|
619
|
|
|
(4,979
|
)
|
||
Operating lease right-of-use assets
|
413
|
|
|
—
|
|
||
Accounts payable
|
(253
|
)
|
|
3,861
|
|
||
Current portion of long-term debt
|
(3,121
|
)
|
|
(308
|
)
|
||
Long-term portion of operating lease liabilities
|
(482
|
)
|
|
—
|
|
||
Accrued liabilities and other liabilities
|
899
|
|
|
(250
|
)
|
||
Net cash used in operating activities
|
(43,807
|
)
|
|
(57,383
|
)
|
||
Cash flows from investing activities
|
|
|
|
||||
Purchases of property and equipment
|
(18
|
)
|
|
(497
|
)
|
||
Purchases of available-for-sale securities
|
(38,657
|
)
|
|
(183,796
|
)
|
||
Maturities of available-for-sale securities
|
88,000
|
|
|
53,560
|
|
||
Net cash provided by (used in) investing activities
|
49,325
|
|
|
(130,733
|
)
|
||
Cash flows from financing activities
|
|
|
|
||||
Proceeds from public offerings, net of offering costs
|
—
|
|
|
134,268
|
|
||
Proceeds from issuance of common stock upon exercise of stock options
|
165
|
|
|
2,293
|
|
||
Proceeds from employee stock purchase plan
|
449
|
|
|
843
|
|
||
Net cash provided by financing activities
|
614
|
|
|
137,404
|
|
||
Net increase (decrease) in cash and cash equivalents
|
6,132
|
|
|
(50,712
|
)
|
||
Cash and cash equivalents at beginning of period
|
56,605
|
|
|
91,316
|
|
||
Cash and cash equivalents at end of period
|
$
|
62,737
|
|
|
$
|
40,604
|
|
Supplemental disclosure of noncash activities
|
|
|
|
||||
Right-of-use assets obtained in exchange for operating lease liabilities
|
$
|
8,005
|
|
|
$
|
—
|
|
Purchases of inventory in accounts payable and accrued expenses
|
$
|
141
|
|
|
$
|
236
|
|
Property and equipment in accounts payable and accrued expense
|
$
|
—
|
|
|
$
|
10
|
|
Stock-based compensation capitalized in inventory
|
$
|
60
|
|
|
$
|
122
|
|
Stock option exercise settled after period end
|
$
|
—
|
|
|
$
|
240
|
|
|
December 31, 2018
|
|
Adjustment due to the Adoption of Topic 842
|
|
January 1, 2019
|
||||||
Operating lease right-of-use assets
|
$
|
—
|
|
|
$
|
7,566
|
|
|
$
|
7,566
|
|
Other current liabilities
|
512
|
|
|
768
|
|
|
1,280
|
|
|||
Long-term portion of operating lease liabilities
|
—
|
|
|
8,643
|
|
|
8,643
|
|
|||
Other non-current liabilities
|
3,196
|
|
|
(1,844
|
)
|
|
1,352
|
|
•
|
Level 1 inputs, which include quoted prices in active markets for identical assets or liabilities;
|
•
|
Level 2 inputs, which include observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the asset or liability. For available-for-sale securities, the Company reviews trading activity and pricing as of the measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities obtained from various third-party data providers. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data; and
|
•
|
Level 3 inputs, which include unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the underlying asset or liability. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies, or similar valuation techniques, as well as significant management judgment or estimation.
|
|
June 30, 2019
|
||||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market
|
$
|
16,089
|
|
|
$
|
16,089
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate debt
|
12,989
|
|
|
—
|
|
|
12,989
|
|
|
—
|
|
||||
U.S. Treasury securities
|
87,951
|
|
|
—
|
|
|
87,951
|
|
|
—
|
|
||||
Commercial paper
|
4,970
|
|
|
—
|
|
|
4,970
|
|
|
—
|
|
||||
Total assets measured at fair value
|
$
|
121,999
|
|
|
$
|
16,089
|
|
|
$
|
105,910
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Embedded derivative liability
|
$
|
1,501
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,501
|
|
Total liabilities measured at fair value
|
$
|
1,501
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,501
|
|
|
December 31, 2018
|
||||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market
|
$
|
17,789
|
|
|
$
|
17,789
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate debt
|
19,792
|
|
|
—
|
|
|
19,792
|
|
|
—
|
|
||||
U.S. Treasury securities
|
131,512
|
|
|
—
|
|
|
131,512
|
|
|
—
|
|
||||
Commercial paper
|
2,961
|
|
|
—
|
|
|
2,961
|
|
|
—
|
|
||||
Total assets measured at fair value
|
$
|
172,054
|
|
|
$
|
17,789
|
|
|
$
|
154,265
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Embedded derivative liability
|
$
|
1,352
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,352
|
|
Total liabilities measured at fair value
|
$
|
1,352
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,352
|
|
Balance as of December 31, 2018
|
$
|
1,352
|
|
Change in fair value included in interest and other income, net
|
149
|
|
|
Balance as of June 30, 2019
|
$
|
1,501
|
|
|
June 30, 2019
|
||||||||||||||
|
Amortized Cost
|
|
Gross Unrealized
Gains
|
|
Gross Unrealized
Losses
|
|
Fair Value
|
||||||||
Investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt
|
$
|
12,965
|
|
|
$
|
24
|
|
|
$
|
—
|
|
|
$
|
12,989
|
|
U.S. Treasury securities
|
87,872
|
|
|
80
|
|
|
(1
|
)
|
|
87,951
|
|
||||
Commercial paper
|
4,970
|
|
|
—
|
|
|
—
|
|
|
4,970
|
|
||||
Total
|
$
|
105,807
|
|
|
$
|
104
|
|
|
$
|
(1
|
)
|
|
$
|
105,910
|
|
Reported as:
|
|
|
|
|
|
|
|
|
|
|
|||||
Short-term investments
|
$
|
105,807
|
|
|
$
|
104
|
|
|
$
|
(1
|
)
|
|
$
|
105,910
|
|
Long-term investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Total
|
$
|
105,807
|
|
|
$
|
104
|
|
|
$
|
(1
|
)
|
|
$
|
105,910
|
|
|
December 31, 2018
|
||||||||||||||
|
Amortized Cost
|
|
Gross Unrealized
Gains
|
|
Gross Unrealized
Losses
|
|
Fair Value
|
||||||||
Investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt
|
$
|
19,833
|
|
|
$
|
—
|
|
|
$
|
(41
|
)
|
|
$
|
19,792
|
|
U.S. Treasury securities
|
131,735
|
|
|
10
|
|
|
(233
|
)
|
|
131,512
|
|
||||
Commercial paper
|
2,961
|
|
|
—
|
|
|
—
|
|
|
2,961
|
|
||||
Total
|
$
|
154,529
|
|
|
$
|
10
|
|
|
$
|
(274
|
)
|
|
$
|
154,265
|
|
Reported as:
|
|
|
|
|
|
|
|
|
|
|
|||||
Short-term investments
|
$
|
154,529
|
|
|
$
|
10
|
|
|
$
|
(274
|
)
|
|
$
|
154,265
|
|
Long-term investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Total
|
$
|
154,529
|
|
|
$
|
10
|
|
|
$
|
(274
|
)
|
|
$
|
154,265
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Raw materials
|
$
|
1,291
|
|
|
$
|
1,330
|
|
Work-in-process
|
1,227
|
|
|
2,174
|
|
||
Finished goods
|
3,135
|
|
|
1,617
|
|
||
Total inventory
|
$
|
5,653
|
|
|
$
|
5,121
|
|
|
June 30, 2019
|
||
Assets
|
|
||
Operating lease right-of-use assets
|
$
|
7,592
|
|
Total right-of-use assets
|
$
|
7,592
|
|
Liabilities
|
|
||
Current portion included in other current liabilities
|
$
|
1,229
|
|
Long-term portion of operating lease liabilities
|
8,367
|
|
|
Total operating lease liabilities
|
$
|
9,596
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||
|
2019
|
|
2019
|
||||
Operating lease cost
|
$
|
472
|
|
|
$
|
930
|
|
Variable lease cost
|
28
|
|
|
56
|
|
||
Total lease cost
|
$
|
500
|
|
|
$
|
986
|
|
|
Operating leases (1)
|
||
2019 (remaining)
|
$
|
1,091
|
|
2020
|
2,220
|
|
|
2021
|
2,242
|
|
|
2022
|
2,181
|
|
|
2023
|
2,181
|
|
|
Thereafter
|
3,011
|
|
|
Total lease payments
|
12,926
|
|
|
Less: Imputed interest
|
(3,330
|
)
|
|
Operating lease liabilities
|
$
|
9,596
|
|
(1)
|
The table above does not include any legally binding minimum lease payments for leases signed but not yet commenced of approximately
$1.1 million
.
|
|
Amount
|
||
2019
|
$
|
1,938
|
|
2020
|
1,996
|
|
|
2021
|
2,056
|
|
|
2022
|
2,118
|
|
|
2023
|
2,181
|
|
|
Thereafter
|
3,011
|
|
|
Total
|
$
|
13,300
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Total repayment obligation
|
$
|
200,000
|
|
|
$
|
200,000
|
|
Less: Interest to be accreted in future periods
|
(70,733
|
)
|
|
(78,261
|
)
|
||
Less: Payments made
|
(5,739
|
)
|
|
(2,618
|
)
|
||
Carrying value of loans payable
|
$
|
123,528
|
|
|
$
|
119,121
|
|
Less: Current portion of long-term debt
|
(1,585
|
)
|
|
(1,664
|
)
|
||
Non-current portion of long-term debt
|
$
|
121,943
|
|
|
$
|
117,457
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||
Common stock awards issued and outstanding
|
6,616,103
|
|
|
5,949,436
|
|
Authorized for future issuance under 2014 Equity Incentive Plan
|
2,292,103
|
|
|
1,814,179
|
|
Authorized for future issuance under 2016 Inducement Plan
|
751,678
|
|
|
512,440
|
|
Employee stock purchase plan
|
1,009,145
|
|
|
847,105
|
|
Total
|
10,669,029
|
|
|
9,123,160
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Research and development
|
$
|
563
|
|
|
$
|
717
|
|
|
$
|
1,153
|
|
|
$
|
1,489
|
|
Selling, general and administrative
|
2,376
|
|
|
3,432
|
|
|
5,170
|
|
|
6,401
|
|
||||
Total stock-based compensation expense
|
$
|
2,939
|
|
|
$
|
4,149
|
|
|
$
|
6,323
|
|
|
$
|
7,890
|
|
|
Three and Six Months Ended
June 30, |
||||
|
2019
|
|
2018
|
||
Options to purchase common stock
|
5,716
|
|
|
5,659
|
|
Restricted stock units
|
900
|
|
|
476
|
|
Total
|
6,616
|
|
|
6,135
|
|
•
|
GOCOVRI
®
(amantadine) extended release capsules, formerly referred to as ADS-5102, is the first and only FDA-approved medication indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF in that population. GOCOVRI was approved for marketing by the U.S. Food and Drug Administration, or FDA, on August 24, 2017, with seven years of orphan exclusivity and additional patent protections out to 2034, and we fully launched GOCOVRI with a deployed sales force in January 2018.
|
•
|
ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. We have initiated the first of two pivotal Phase 3 studies in this supplemental indication with enrollment completed and topline results expected late in the fourth quarter of 2019.
|
•
|
ADS-5102 in research and potential development for additional indications. We expect to complete and announce the results of our assessment of potential additional indications for ADS-5102 if and when specific clinical trials are initiated.
|
•
|
Namzaric
®
(memantine hydrochloride extended release and donepezil hydrochloride) capsules for the treatment of moderate to severe dementia of an Alzheimer’s type, marketed in the United States by Allergan plc under an exclusive license agreement between us and Forest Laboratories Holdings Limited (“Forest”), an indirect wholly-owned subsidiary of Allergan plc (collectively, “Allergan”).
|
•
|
fees paid to clinical investigators, clinical trial sites, consultants, and vendors, including contract research organizations, or CROs, in conjunction with implementing, conducting, and monitoring our clinical trials and acquiring and evaluating clinical trial data, including all related fees, such as for investigator grants, patient screening fees, laboratory work, and statistical compilation and analysis;
|
•
|
expenses related to production of clinical supplies, including fees paid to contract manufacturing organizations, or CMOs;
|
•
|
expenses related to establishment and validation of manufacturing capabilities for commercial supply;
|
•
|
expenses related to the buildup of commercial supply to support commercial launch, prior to FDA approval;
|
•
|
expenses related to compliance with regulatory requirements;
|
•
|
other consulting fees paid to third parties; and
|
•
|
employee-related expenses, which include salaries, benefits, and stock-based compensation.
|
|
Three Months Ended
June 30, |
|
Increase
(Decrease)
|
|
Six Months Ended
June 30, |
|
Increase
(Decrease) |
||||||||||||||||
|
2019
|
|
2018
|
|
|
2019
|
|
2018
|
|
||||||||||||||
GOCOVRI
(1)
|
$
|
6,234
|
|
|
$
|
7,107
|
|
|
$
|
(873
|
)
|
|
$
|
13,276
|
|
|
$
|
12,689
|
|
|
$
|
587
|
|
ADS-4101
(2)
|
1,001
|
|
|
1,426
|
|
|
(425
|
)
|
|
2,459
|
|
|
2,363
|
|
|
96
|
|
||||||
Other research and development expenses
|
1,363
|
|
|
1,273
|
|
|
90
|
|
|
3,077
|
|
|
1,942
|
|
|
1,135
|
|
||||||
Total research and development expenses
|
$
|
8,598
|
|
|
$
|
9,806
|
|
|
$
|
(1,208
|
)
|
|
$
|
18,812
|
|
|
$
|
16,994
|
|
|
$
|
1,818
|
|
(1)
|
Includes program costs we incurred for GOCOVRI (formerly referred to as ADS-5102) for the treatment of dyskinesia in patients with Parkinson’s disease, and ADS-5102 (GOCOVRI) for additional potential CNS indications, including for the treatment of walking impairment in patients with multiple sclerosis.
|
(2)
|
We reduced investments in ADS-4101 in the quarter ended June 30, 2019.
|
|
Three Months Ended
June 30, |
|
Increase
(Decrease)
|
|
% Increase
(Decrease)
|
|
Six Months Ended
June 30, |
|
Increase
(Decrease) |
|
% Increase
(Decrease) |
||||||||||||||||||
|
2019
|
|
2018
|
|
|
|
2019
|
|
2018
|
|
|
||||||||||||||||||
Product sales
|
$
|
12,691
|
|
|
$
|
7,565
|
|
|
$
|
5,126
|
|
|
68
|
%
|
|
$
|
24,356
|
|
|
$
|
10,118
|
|
|
$
|
14,238
|
|
|
141
|
%
|
Cost of product sales
|
685
|
|
|
73
|
|
|
612
|
|
|
NM
|
|
|
1,098
|
|
|
98
|
|
|
1,000
|
|
|
NM
|
|
||||||
Research and development expenses
|
8,598
|
|
|
9,806
|
|
|
(1,208
|
)
|
|
(12
|
)%
|
|
18,812
|
|
|
16,994
|
|
|
1,818
|
|
|
11
|
%
|
||||||
Selling, general and administrative expenses, net
|
25,216
|
|
|
27,699
|
|
|
(2,483
|
)
|
|
(9
|
)%
|
|
52,904
|
|
|
54,062
|
|
|
(1,158
|
)
|
|
(2
|
)%
|
||||||
Interest and other income, net
|
734
|
|
|
1,132
|
|
|
(398
|
)
|
|
(35
|
)%
|
|
1,457
|
|
|
2,010
|
|
|
(553
|
)
|
|
(28
|
)%
|
||||||
Interest expense
|
3,797
|
|
|
5,112
|
|
|
(1,315
|
)
|
|
(26
|
)%
|
|
7,528
|
|
|
9,938
|
|
|
(2,410
|
)
|
|
(24
|
)%
|
|
Six Months Ended
June 30, |
||||||
|
2019
|
|
2018
|
||||
Net cash (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(43,807
|
)
|
|
$
|
(57,383
|
)
|
Investing activities
|
49,325
|
|
|
(130,733
|
)
|
||
Financing activities
|
614
|
|
|
137,404
|
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
6,132
|
|
|
$
|
(50,712
|
)
|
•
|
our success in the marketing, sales, and distribution of GOCOVRI;
|
•
|
successfully establishing and maintaining commercial manufacturing with third parties;
|
•
|
acceptance of GOCOVRI by physicians, patients and the healthcare community;
|
•
|
coverage and adequate reimbursement of GOCOVRI by third-party payers;
|
•
|
willingness and ability of patients to pay out of pocket for GOCOVRI;
|
•
|
effectively competing with other approved or used medicines and future compounds in development;
|
•
|
continued demonstration of an acceptable safety profile of GOCOVRI following approval; and
|
•
|
obtaining, maintaining, enforcing, and defending intellectual property rights and claims.
|
•
|
its efficacy, duration of response, and potential advantages compared to alternative treatments;
|
•
|
the prevalence and severity of any side effects;
|
•
|
the acceptability of the price of GOCOVRI relative to other treatments;
|
•
|
the willingness of physicians to change their current treatment practices;
|
•
|
its convenience and ease of administration compared to alternative treatments;
|
•
|
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
|
•
|
the effectiveness of our marketing, promotion, selling, and distribution support; and
|
•
|
the availability of third-party payer coverage and adequate reimbursement.
|
•
|
regulatory authorities may require the addition of labeling statements, specific warnings, contraindications, or field alerts to physicians and pharmacies;
|
•
|
regulatory authorities may withdraw their approval of the product and require us to take our approved drugs off the market;
|
•
|
we may be required to change the way the product is administered, conduct additional clinical trials, change the labeling of the product, or implement a Risk Evaluation and Mitigation Strategy, or REMS;
|
•
|
we may have limitations on how we promote our drugs;
|
•
|
third-party payers may limit coverage or reimbursement for GOCOVRI;
|
•
|
sales of GOCOVRI may decrease significantly;
|
•
|
we may be subject to litigation or product liability claims; and
|
•
|
our reputation may suffer.
|
•
|
decreased demand for any product candidates or products that we may develop;
|
•
|
the inability to commercialize any products that we may develop;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of patients from clinical studies or cancellation of studies;
|
•
|
significant costs to defend the related litigation;
|
•
|
substantial monetary awards to patients; and
|
•
|
loss of revenue.
|
•
|
successfully completing the development program for our product candidates in a timely manner;
|
•
|
receiving marketing approval for our product candidates from the FDA in a timely manner;
|
•
|
successfully establishing and maintaining commercial manufacturing with third parties;
|
•
|
commercializing our product candidates, if approved, including marketing, sales, and distribution of the product independently or in partnership with another company;
|
•
|
acceptance by the medical community and patients of the approved product;
|
•
|
coverage and adequate reimbursement of our product candidates by third-party payers;
|
•
|
willingness and ability of patients to pay out of pocket for our product candidates;
|
•
|
effectively competing with other approved or used medicines and future compounds in development;
|
•
|
continued demonstration of an acceptable safety profile of the approved products following approval; and
|
•
|
obtaining, maintaining, enforcing, and defending intellectual property rights and claims.
|
•
|
clinical studies may produce negative or inconclusive results or raise significant safety concerns, and we may decide, or regulators may require us, to conduct additional clinical studies or abandon product development programs;
|
•
|
even if clinical studies demonstrate statistically significant efficacy and acceptable safety, the FDA or similar authorities outside the United States may not consider the results of our studies to be sufficient for approval;
|
•
|
our clinical sites and clinical investigators may fail to comply with, or inconsistently apply, the trial protocols, regulatory requirements including Good Clinical Practices, contractual obligations, and the rating assessments;
|
•
|
our third-party vendors, including our Contract Research Organizations, or CROs, and contract manufacturing organizations, or CMOs, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
|
•
|
we might have to suspend or terminate clinical studies for various reasons, including a finding that our product candidates have unanticipated serious side effects or other unexpected characteristics or that the patients are being exposed to unacceptable health risks;
|
•
|
regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements;
|
•
|
the supply or quality of ADS-5102 or other materials necessary to conduct clinical studies may be insufficient or inadequate; and
|
•
|
our new product discovery or research program may not be successful or warrant clinical development.
|
•
|
partners have significant discretion in determining the efforts and resources that they will apply to collaborations;
|
•
|
partners may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical study results, changes in
|
•
|
partners may delay clinical studies, provide insufficient funding for a clinical study program, stop a clinical study, abandon a product candidate, repeat or conduct new clinical studies, or require a new formulation of a product candidate for clinical testing;
|
•
|
partners could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;
|
•
|
a partner with marketing, manufacturing, and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;
|
•
|
we could grant exclusive rights to our partners that would prevent us from collaborating with others;
|
•
|
partners may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;
|
•
|
partners may not aggressively or adequately pursue litigation against ANDA filers or may settle such litigation on unfavorable terms, as they may have different economic interests than ours, and such decisions could negatively impact any royalties we may receive under our license agreements;
|
•
|
disputes may arise between us and a partner that causes the delay or termination of the research, development, or commercialization of our current or future products or that results in costly litigation or arbitration that diverts management attention and resources;
|
•
|
agreements may be terminated, sometimes at-will, without penalty, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products;
|
•
|
partners may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property; and
|
•
|
a partner’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.
|
•
|
our ability to set a price we believe is fair for our products;
|
•
|
the reputation of our company;
|
•
|
our ability to generate revenue and achieve or maintain profitability; and
|
•
|
the availability of capital.
|
•
|
warning letters or untitled letters;
|
•
|
civil or criminal penalties and fines;
|
•
|
injunctions;
|
•
|
suspension, variation, or withdrawal of regulatory approval;
|
•
|
suspension of ongoing clinical studies;
|
•
|
voluntary or mandatory product recalls;
|
•
|
requirements for dissemination of corrective information or modifications to promotional materials;
|
•
|
refusal to approve pending applications for marketing approval of new drugs or supplements to approved applications filed by us;
|
•
|
refusal to permit import or export of our products;
|
•
|
restrictions on operations, including costly new manufacturing requirements; or
|
•
|
seizure or detention of our products.
|
•
|
the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order, lease, arrangement or recommendation of, any good, facility, item, or service for which payment may be made, in whole or in part, under federal healthcare programs, such as the Medicare and Medicaid programs. Liability under the Anti-Kickback Statute may be established without a person or entity having actual knowledge of the statute or specific intent to violate it. In addition, the government may assert that a claim including items or services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act;
|
•
|
the federal civil and criminal false claims laws, including the federal civil False Claims Act and civil monetary penalties laws, which prohibits individuals or entities from, among other things, knowingly presenting, or causing to be presented, false or fraudulent claims for payment of government funds, or knowingly using false records or statements, to obtain payment from the federal government. In recent years, several pharmaceutical and other health care companies have faced enforcement actions under the False Claims Act for, among other things, allegedly submitting false or misleading pricing information to government healthcare programs, providing free product to customers with the expectation that the customers would bill federal programs, product and patient assistance programs, including reimbursement services, and marketing products for off-label or unapproved uses;
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private) and knowingly and willfully falsifying, concealing, or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items, or services relating to healthcare matters;
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their implementing regulations, which impose obligations on HIPAA covered entities and their business associates, including mandatory contractual terms and required implementation of administrative, physical and technical safeguards to maintain the privacy and security of individually identifiable health information;
|
•
|
the federal Physician Payments Sunshine Act, being implemented as the Open Payments Program, which requires manufacturers of drugs, devices, biologicals, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to the federal government information related to payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching
|
•
|
analogous state laws and regulations, such as anti-kickback, and false claims laws, which may be broader in scope and apply to items or services reimbursed by any third-party payer, including commercial insurers. Several states also require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products in those states and to report gifts and payments to individual health care providers in those states. Some of these states also prohibit certain marketing-relating activities, including the provision of gifts, meals, or other items to certain health care providers. Some states require reporting with respect to certain drug products. Certain state and localities also require the registration of pharmaceutical sales representatives. In addition, several states require pharmaceutical companies to implement compliance programs or marketing codes.
|
•
|
disagreement with the design or implementation of our clinical trials;
|
•
|
failure of clinical trials to show the level of statistical significance or clinical meaningfulness needed for approval;
|
•
|
failure to demonstrate that a product candidate is safe or effective;
|
•
|
insufficient data from preclinical and clinical studies to support an application;
|
•
|
a finding by an institutional review board, or IRB, Data Safety Monitoring Board, or DSMB, Data Monitoring Committee, or DMC, or the FDA that the clinical trial exposes subjects or patients to an unacceptable health risk;
|
•
|
disapproval of our or our third-party manufacturer’s processes or facilities; or
|
•
|
changes to FDA’s approval policies or regulations.
|
•
|
determine the efforts and resources that they apply towards commercialization;
|
•
|
market, manufacture, and distribute the licensed products or to otherwise not perform satisfactorily in carrying out these activities; and
|
•
|
to terminate the agreement without penalty and, such termination, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products.
|
•
|
maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; and
|
•
|
not adequately pursue litigation against ANDA filers or settle such litigation on unfavorable terms, and as Allergan substantially controls any ANDA litigation and terms of settlement and has different economic interests than ours, Allergan may grant licenses to generic manufacturers that permit them to make and sell generic versions of Namzaric, which would negatively impact the royalties we receive under our license with Allergan.
|
•
|
the level of demand for our products, which may vary significantly as they are launched and compete for position in the marketplace;
|
•
|
pricing and reimbursement policies with respect to GOCOVRI and product candidates, if approved, and the competitive response from existing and potential future therapeutic approaches that compete with our product candidates;
|
•
|
the cost of manufacturing our product candidates, which may vary due to a number of factors, including the terms of our agreements with contract manufacturing organizations, or CMOs;
|
•
|
the timing, cost, level of investment, and success or failure of research and development activities relating to our preclinical and clinical-stage product candidates, which may change from time to time;
|
•
|
expenditures that we may incur to acquire and develop additional product candidates and technologies;
|
•
|
the timing and success or failure of clinical studies for competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;
|
•
|
the timing and magnitude of upfront and milestone payments under any potential future collaboration and licensing agreements;
|
•
|
future accounting pronouncements or changes in our accounting policies; and
|
•
|
changing or volatile U.S., European, and global economic environments.
|
•
|
enhance operational, financial, and information management systems and hire more personnel, including personnel to support development of our product candidates and, our commercial operations;
|
•
|
commercialize GOCOVRI, including establishing distribution, marketing, and sales capabilities;
|
•
|
manufacture GOCOVRI for commercial use;
|
•
|
investigate ADS-5102 (GOCOVRI) in preclinical and clinical trials for the treatment of walking impairment in patients with MS, and potentially other indications;
|
•
|
seek regulatory approvals for our product candidates that successfully complete clinical studies;
|
•
|
continue the research, development, and manufacture of our current product candidates; and
|
•
|
seek to discover or in-license additional product candidates.
|
•
|
our success in commercializing GOCOVRI for the treatment of dyskinesia in patients with Parkinson’s disease;
|
•
|
the availability of reimbursement by third-party payers at acceptable levels, or at all, for GOCOVRI;
|
•
|
the success of competitive products or technologies;
|
•
|
results of clinical studies of our product candidates or those of our competitors;
|
•
|
introductions and announcements of new products and product candidates by us, our commercialization partners, or our competitors, and the timing of these introductions or announcements;
|
•
|
actions taken by regulatory agencies with respect to our or our competitors’ products, product candidates, clinical studies, manufacturing process, or sales and marketing terms;
|
•
|
variations in our financial results or those of companies that are perceived to be comparable to us;
|
•
|
our revenue performance, both in absolute terms and relative to analyst and shareholder expectations;
|
•
|
the success of our efforts to acquire or in-license additional products or product candidates;
|
•
|
developments concerning our collaborations, including but not limited to those with our sources of manufacturing and our commercialization partners;
|
•
|
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, or capital commitments;
|
•
|
developments or disputes concerning patents or other proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our current or future products;
|
•
|
our ability or inability to raise additional capital and the terms on which we raise it;
|
•
|
the recruitment or departure of key personnel;
|
•
|
changes in the structure of healthcare reimbursement systems;
|
•
|
regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our current or future products;
|
•
|
market conditions in the pharmaceutical and biotechnology sectors;
|
•
|
actual or anticipated changes in revenue forecasts, earnings estimates or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally;
|
•
|
trading volume of our common stock;
|
•
|
sales of our common stock by us or our stockholders;
|
•
|
general economic, industry, and market conditions; and
|
•
|
the other risks described in this “Risk Factors” section.
|
•
|
our board of directors is divided into three classes with staggered three-year terms, which may delay or prevent a change of our management or a change in control;
|
•
|
our board of directors has the right to change the size of our board of directors and to elect directors to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on our board of directors;
|
•
|
our stockholders may not act by written consent or call special stockholders’ meetings; as a result, a holder, or holders, controlling a majority of our capital stock would not be able to take certain actions other than at annual stockholders’ meetings or special stockholders’ meetings called by the board of directors or the chairman of the board and chief executive officer;
|
•
|
our certificate of incorporation prohibits cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;
|
•
|
stockholders must provide advance notice and additional disclosures in order to nominate individuals for election to the board of directors or to propose matters that can be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of our company; and
|
•
|
our board of directors may issue, without stockholder approval, shares of undesignated preferred stock, and the ability to issue undesignated preferred stock makes it possible for our board of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to acquire us.
|
•
|
different regulatory requirements for drug approvals in foreign countries;
|
•
|
reduced protection for intellectual property rights;
|
•
|
unexpected changes in tariffs, trade barriers, and regulatory requirements;
|
•
|
different payer reimbursement regimes, governmental payers or patient self-pay systems and price controls;
|
•
|
economic weakness, including inflation or political instability in particular foreign economies and markets;
|
•
|
difficulties in assuring compliance with foreign corrupt practices laws;
|
•
|
compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad;
|
•
|
foreign taxes, including withholding of payroll taxes;
|
•
|
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
|
•
|
workforce uncertainty in countries where labor unrest is more common than in the United States;
|
•
|
compliance with privacy laws;
|
•
|
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
|
•
|
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, hurricanes or typhoons, floods, and fires.
|
Exhibit Number
|
|
|
|
Incorporation By Reference
|
|
Filed / Furnished Herewith
|
||||||
|
Exhibit Description
|
|
Form
|
|
SEC File No.
|
|
Exhibit
|
|
Filing Date
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amended and Restated Certificate of Incorporation of Adamas Pharmaceuticals, Inc.
|
|
8-K
|
|
001-36399
|
|
3.1
|
|
4/15/2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amended and Restated Bylaws of Adamas Pharmaceuticals, Inc.
|
|
S-1
|
|
333-194342
|
|
3.4
|
|
3/5/2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4.1
|
|
Reference is made to Exhibits 3.1 through 3.2.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Form of Common Stock Certificate of Adamas Pharmaceuticals, Inc.
|
|
S-1
|
|
333-194342
|
|
4.1
|
|
3/26/2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Offer Letter by and between Adamas Pharmaceuticals, Inc. and Vijay Shreedhar, Ph.D., dated May 14, 2019.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Amendment to Amended and Restated Commercial Supply Agreement by and between Adamas Pharmaceuticals, Inc. and Catalent Pharma Solutions, LLC.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2019 Compensation Arrangements with Executive Officers.
|
|
8-K
|
|
333-194342
|
|
Item 5.02
|
|
4/10/2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.(1)
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
|
|
Adamas Pharmaceuticals, Inc.
|
|
(Registrant)
|
Date:
|
August 8, 2019
|
/s/ Gregory T. Went, Ph.D.
|
|
|
Gregory T. Went, Ph.D.
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
Date:
|
August 8, 2019
|
/s/ Alfred G. Merriweather
|
|
|
Alfred G. Merriweather
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
•
|
Confidential Information and Inventions Agreement
|
•
|
Executive Severance Plan
|
/s/ Vijay Shreedhar
|
|
|
NAME
|
|
|
|
|
|
May 14, 2019
|
|
|
Date
|
|
|
(i)
|
Amantadine HCl Specifications
shall be updated.
|
(ii)
|
[*] shall be added to the list of Client-Supplied Materials (as such term is defined in Section 1.17 of the Amended and Restated Agreement). Accordingly, it shall be removed from the list of Raw Materials.
|
(iii)
|
The list of Raw Materials (and sourcing Party for each) shall be updated.
|
(i)
|
The Commercial Manufacturing Pricing for the [*] shall be revised.
|
(ii)
|
Campaign sizes in sections A and B adjusted to align with pricing assumptions.
|
(iii)
|
Yield averages for the [*] shall be updated to reflect actual value following process validation. Accordingly, the following sentence shall be deleted:
|
(iv)
|
The third line item which reads “Pricing excludes the cost of API” shall be replaced with the following sentence: “Pricing excludes the cost of API and [*].
|
(v)
|
The Minimum Requirements shall be revised per the amended Attachment C attached hereto.
|
(i)
|
For Contract Year 1,
starting from the Restatement Effective Date and ending after the 12-month period beginning on the Commencement Date;
|
(ii)
|
B
eginning with Contract Year 2, the 12-month period beginning at the conclusion of Contract Year 1 and ending on the second December 31 thereafter; and,
|
(iii)
|
Thereafter, each consecutive twelve (12) month period beginning on January 1 and ending on December 31 (“Contract Year 3”, “Contract Year 4”, etc.).
|
CATALENT PHARMA SOLUTIONS, LLC
|
|
ADAMAS PHARMA, LLC
|
|
||
|
|
|
|
|
|
By:
|
/s/Michael J. Valazza
|
|
By:
|
/s/Jennifer Rhodes
|
|
Name:
|
Michael J. Valazza
|
|
Name:
|
Jennifer Rhodes
|
|
Title:
|
Vice President, Business Development
|
|
Title:
|
General Counsel
|
|
I.
|
Client-supplied Materials (and associated specifications)
|
II.
|
Raw Materials (and associated specifications) and Qualified Vendor List
|
III.
|
Product Specifications (including Batch size)
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Adamas Pharmaceuticals, 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 registrant’s other certifying officer 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;
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c)
|
evaluated the effectiveness of the registrant’s 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
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d)
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during registrant’s most recent fiscal quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
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5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
all significant deficiencies and material weakness in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s 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 registrant’s internal control over financial reporting.
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Date:
|
August 8, 2019
|
/s/ Gregory T. Went, Ph.D.
|
|
|
Gregory T. Went, Ph.D.
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Adamas Pharmaceuticals, 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 registrant’s other certifying officer 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 registrant’s 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 registrant’s internal control over financial reporting that occurred during registrant’s most recent fiscal quarter (the registrant’s fourth quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
all significant deficiencies and material weakness in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s 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 registrant’s internal control over financial reporting.
|
Date:
|
August 8, 2019
|
/s/ Alfred G. Merriweather
|
|
|
Alfred G. Merriweather
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
1.
|
The Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2019
, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
|
2.
|
The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Gregory T. Went, Ph.D.
|
|
/s/ Alfred G. Merriweather
|
Gregory T. Went, Ph.D.
|
|
Alfred G. Merriweather
|
Chief Executive Officer
|
|
Chief Financial Officer
|
(Principal Executive Officer)
|
|
(Principal Financial Officer)
|