☒
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Commission File Number: 000-28508
|
Ireland
|
000-28508
|
98-1341933
|
(State or Other Jurisdiction of Incorporation)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
American Depositary Shares*
|
AVDL
|
The Nasdaq Global Market
|
Ordinary Shares, nominal value $0.01 per share**
|
N/A
|
|
Large accelerated filer
|
¨
|
Accelerated filer
|
þ
|
Non-accelerated
|
¨
|
Smaller reporting company
|
☐
|
|
|
Emerging growth company
|
☐
|
|
|
Page #
|
|
|
|
|
||
Item 1.
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
|
|
|
|
||
Item 1.
|
||
Item 1A.
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
Item 5.
|
||
Item 6.
|
•
|
Our reliance on a single product candidate, FT218, and our ability to obtain regulatory approval of and successfully commercialize FT218, including any delays in submission or approval related to COVID-19;
|
•
|
Our plans and expectations regarding the effectiveness of our restructuring plan announced in February 2019, including our ability to achieve the desired cost savings;
|
•
|
Any further restructuring actions that may be required and our ability to obtain any required consents (including any consents required pursuant to the Indenture governing our exchange notes due 2023, or the 2023 Notes);
|
•
|
Our ability to continue to service the 2023 Notes, including making the ongoing interest payments on the 2023 Notes, settling exchanges of the 2023 Notes in cash or completing any required repurchases of the 2023 Notes;
|
•
|
The ability of our product candidates, if approved, to gain market acceptance;
|
•
|
Our ability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our product candidates;
|
•
|
Our dependence on a limited number of suppliers for the manufacturing of our products and certain raw materials in our products and any failure of such suppliers to deliver sufficient quantities of these raw materials, which could have a material adverse effect on our business;
|
•
|
Our ability to finance our operations on acceptable terms, either through the raising of capital, the incurrence of convertible or other indebtedness or through strategic financing or commercialization partnerships;
|
•
|
Our expectations about the potential market sizes and market participation potential for our approved or proposed products;
|
•
|
The potential impact of COVID-19 on our business and future operating results;
|
•
|
Our ability to retain members of our management team and our employees; and
|
•
|
Competition existing today or that will likely arise in the future.
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Product sales
|
|
$
|
10,091
|
|
|
$
|
17,554
|
|
|
$
|
22,334
|
|
|
$
|
33,991
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of products
|
|
3,285
|
|
|
3,622
|
|
|
5,742
|
|
|
6,888
|
|
||||
Research and development expenses
|
|
4,057
|
|
|
10,292
|
|
|
9,587
|
|
|
17,621
|
|
||||
Selling, general and administrative expenses
|
|
7,095
|
|
|
6,758
|
|
|
15,008
|
|
|
17,204
|
|
||||
Intangible asset amortization
|
|
203
|
|
|
204
|
|
|
406
|
|
|
405
|
|
||||
Changes in fair value of contingent consideration
|
|
918
|
|
|
(377
|
)
|
|
3,396
|
|
|
1,757
|
|
||||
Gain on sale of hospital business
|
|
(45,760
|
)
|
|
—
|
|
|
(45,760
|
)
|
|
—
|
|
||||
Restructuring costs
|
|
24
|
|
|
1,506
|
|
|
183
|
|
|
2,734
|
|
||||
Total operating (income) expense
|
|
(30,178
|
)
|
|
22,005
|
|
|
(11,438
|
)
|
|
46,609
|
|
||||
Operating income (loss)
|
|
40,269
|
|
|
(4,451
|
)
|
|
33,772
|
|
|
(12,618
|
)
|
||||
Investment and other (expense) income, net
|
|
(741
|
)
|
|
950
|
|
|
(1,119
|
)
|
|
1,767
|
|
||||
Interest expense
|
|
(3,237
|
)
|
|
(3,106
|
)
|
|
(6,427
|
)
|
|
(6,168
|
)
|
||||
Loss on deconsolidation of subsidiary
|
|
—
|
|
|
(167
|
)
|
|
—
|
|
|
(2,840
|
)
|
||||
Other expense - changes in fair value of contingent consideration payable
|
|
(125
|
)
|
|
(50
|
)
|
|
(435
|
)
|
|
(357
|
)
|
||||
Income (loss) before income taxes
|
|
36,166
|
|
|
(6,824
|
)
|
|
25,791
|
|
|
(20,216
|
)
|
||||
Income tax provision (benefit)
|
|
5,292
|
|
|
1,781
|
|
|
(4,218
|
)
|
|
1,407
|
|
||||
Net income (loss)
|
|
$
|
30,874
|
|
|
$
|
(8,605
|
)
|
|
$
|
30,009
|
|
|
$
|
(21,623
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
Net income (loss) per share - basic
|
|
$
|
0.57
|
|
|
$
|
(0.23
|
)
|
|
$
|
0.63
|
|
|
$
|
(0.58
|
)
|
Net income (loss) per share - diluted
|
|
0.49
|
|
|
(0.23
|
)
|
|
0.58
|
|
|
(0.58
|
)
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Weighted average number of shares outstanding - basic
|
|
54,272
|
|
|
37,356
|
|
|
47,665
|
|
|
37,355
|
|
||||
Weighted average number of shares outstanding - diluted
|
|
69,942
|
|
|
37,356
|
|
|
63,083
|
|
|
37,355
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Net income (loss)
|
|
$
|
30,874
|
|
|
$
|
(8,605
|
)
|
|
$
|
30,009
|
|
|
$
|
(21,623
|
)
|
Other comprehensive (loss) income, net of tax:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Foreign currency translation gain (loss)
|
|
182
|
|
|
62
|
|
|
5
|
|
|
(99
|
)
|
||||
Net other comprehensive income, net of ($81), ($23), ($130) and ($41) tax, respectively
|
|
927
|
|
|
293
|
|
|
283
|
|
|
667
|
|
||||
Total other comprehensive income (loss), net of tax
|
|
1,109
|
|
|
355
|
|
|
288
|
|
|
568
|
|
||||
Total comprehensive income (loss)
|
|
$
|
31,983
|
|
|
$
|
(8,250
|
)
|
|
$
|
30,297
|
|
|
$
|
(21,055
|
)
|
|
|
June 30, 2020
|
|
December 31, 2019
|
||||
|
|
(unaudited)
|
|
|
||||
ASSETS
|
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
|
||
Cash and cash equivalents
|
|
$
|
102,174
|
|
|
$
|
9,774
|
|
Marketable securities
|
|
136,380
|
|
|
54,384
|
|
||
Accounts receivable
|
|
5,692
|
|
|
8,281
|
|
||
Inventories
|
|
—
|
|
|
3,570
|
|
||
Research and development tax credit receivable
|
|
—
|
|
|
2,107
|
|
||
Prepaid expenses and other current assets
|
|
32,773
|
|
|
4,264
|
|
||
Total current assets
|
|
277,019
|
|
|
82,380
|
|
||
Property and equipment, net
|
|
407
|
|
|
544
|
|
||
Operating lease right-of-use assets
|
|
3,117
|
|
|
3,612
|
|
||
Goodwill
|
|
16,836
|
|
|
18,491
|
|
||
Intangible assets, net
|
|
—
|
|
|
813
|
|
||
Research and development tax credit receivable
|
|
6,407
|
|
|
6,322
|
|
||
Other non-current assets
|
|
37,615
|
|
|
39,274
|
|
||
Total assets
|
|
$
|
341,401
|
|
|
$
|
151,436
|
|
|
|
|
|
|
||||
LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT)
|
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
|
||
Current portion of long-term contingent consideration payable
|
|
$
|
1,914
|
|
|
$
|
5,554
|
|
Current portion of operating lease liability
|
|
563
|
|
|
645
|
|
||
Accounts payable
|
|
4,879
|
|
|
6,100
|
|
||
Accrued expenses
|
|
15,820
|
|
|
19,810
|
|
||
Income taxes
|
|
354
|
|
|
43
|
|
||
Other current liabilities
|
|
3,488
|
|
|
3,832
|
|
||
Total current liabilities
|
|
27,018
|
|
|
35,984
|
|
||
Long-term debt
|
|
124,879
|
|
|
121,686
|
|
||
Long-term contingent consideration payable, less current portion
|
|
—
|
|
|
11,773
|
|
||
Long-term operating lease liability
|
|
2,087
|
|
|
2,319
|
|
||
Other non-current liabilities
|
|
5,292
|
|
|
8,873
|
|
||
Total liabilities
|
|
159,276
|
|
|
180,635
|
|
||
|
|
|
|
|
||||
Shareholders’ equity (deficit):
|
|
|
|
|
|
|
||
Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; 488 issued and outstanding at June 30, 2020 and none issued and outstanding at December 31, 2019, respectively
|
|
5
|
|
|
—
|
|
||
Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 63,536 issued and 58,129 outstanding at June 30, 2020 and 42,927 issued and 37,520 outstanding at December 31, 2019
|
|
635
|
|
|
429
|
|
||
Treasury shares, at cost, 5,407 shares held at June 30, 2020 and December 31, 2019, respectively
|
|
(49,998
|
)
|
|
(49,998
|
)
|
||
Additional paid-in capital
|
|
615,207
|
|
|
434,391
|
|
||
Accumulated deficit
|
|
(361,206
|
)
|
|
(391,215
|
)
|
||
Accumulated other comprehensive loss
|
|
(22,518
|
)
|
|
(22,806
|
)
|
||
Total shareholders’ equity (deficit)
|
|
182,125
|
|
|
(29,199
|
)
|
||
Total liabilities and shareholders’ equity (deficit)
|
|
$
|
341,401
|
|
|
$
|
151,436
|
|
|
|
Ordinary shares
|
|
Preferred shares
|
|
Additional
|
|
Accumulated
|
|
Accumulated
other
comprehensive
|
|
Treasury shares
|
|
Total
shareholders’
|
|||||||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
paid-in capital
|
|
deficit
|
|
loss
|
|
Shares
|
|
Amount
|
|
equity (deficit)
|
|||||||||||||||||
Balance, December 31, 2019
|
|
42,927
|
|
|
$
|
429
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
434,391
|
|
|
$
|
(391,215
|
)
|
|
$
|
(22,806
|
)
|
|
5,407
|
|
|
$
|
(49,998
|
)
|
|
$
|
(29,199
|
)
|
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(865
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(865
|
)
|
|||||||
Other comprehensive loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(821
|
)
|
|
—
|
|
|
—
|
|
|
(821
|
)
|
|||||||
Exercise of stock options
|
|
146
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
1,387
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,389
|
|
|||||||
February 2020 private placement
|
|
8,680
|
|
|
87
|
|
|
488
|
|
|
5
|
|
|
60,641
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
60,733
|
|
|||||||
Vesting of restricted shares
|
|
19
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Employee share purchase plan share issuance
|
|
40
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
88
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
88
|
|
|||||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
742
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
742
|
|
|||||||
Balance, March 31, 2020
|
|
51,812
|
|
|
$
|
518
|
|
|
488
|
|
|
$
|
5
|
|
|
$
|
497,249
|
|
|
$
|
(392,080
|
)
|
|
$
|
(23,627
|
)
|
|
5,407
|
|
|
$
|
(49,998
|
)
|
|
$
|
32,067
|
|
Net income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
30,874
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
30,874
|
|
|||||||
Other comprehensive income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,109
|
|
|
—
|
|
|
—
|
|
|
1,109
|
|
|||||||
Exercise of stock options
|
|
95
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
392
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
393
|
|
|||||||
February 2020 private placement
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(94
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(94
|
)
|
|||||||
May 2020 public offering
|
|
11,630
|
|
|
116
|
|
|
—
|
|
|
—
|
|
|
116,858
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
116,974
|
|
|||||||
Employee share purchase plan share issuance
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
33
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
33
|
|
|||||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
769
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
769
|
|
|||||||
Balance, June 30, 2020
|
|
63,537
|
|
|
$
|
635
|
|
|
488
|
|
|
$
|
5
|
|
|
$
|
615,207
|
|
|
$
|
(361,206
|
)
|
|
$
|
(22,518
|
)
|
|
5,407
|
|
|
$
|
(49,998
|
)
|
|
$
|
182,125
|
|
|
|
Ordinary shares
|
|
Additional
|
|
Accumulated
|
|
Accumulated
other
comprehensive
|
|
Treasury shares
|
|
Total
shareholders’
|
||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
paid-in capital
|
|
deficit
|
|
(loss) income
|
|
Shares
|
|
Amount
|
|
equity (deficit)
|
||||||||||||||
Balance, December 31, 2018
|
|
42,720
|
|
|
$
|
427
|
|
|
$
|
433,756
|
|
|
$
|
(357,989
|
)
|
|
$
|
(23,416
|
)
|
|
5,407
|
|
|
$
|
(49,998
|
)
|
|
$
|
2,780
|
|
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13,018
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13,018
|
)
|
||||||
Other comprehensive income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
213
|
|
|
—
|
|
|
—
|
|
|
213
|
|
||||||
Vesting of restricted shares
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Employee share purchase plan share issuance
|
|
42
|
|
|
—
|
|
|
92
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
92
|
|
||||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
351
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
351
|
|
||||||
Balance, March 31, 2019
|
|
42,763
|
|
|
$
|
427
|
|
|
$
|
434,199
|
|
|
$
|
(371,007
|
)
|
|
$
|
(23,203
|
)
|
|
5,407
|
|
|
$
|
(49,998
|
)
|
|
$
|
(9,582
|
)
|
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(8,605
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(8,605
|
)
|
||||||
Other comprehensive income
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
355
|
|
|
—
|
|
|
—
|
|
|
355
|
|
||||||
Stock-based compensation expense
|
|
—
|
|
|
—
|
|
|
55
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
55
|
|
||||||
Balance, June 30, 2019
|
|
42,763
|
|
|
$
|
427
|
|
|
$
|
434,254
|
|
|
$
|
(379,612
|
)
|
|
$
|
(22,848
|
)
|
|
5,407
|
|
|
$
|
(49,998
|
)
|
|
$
|
(17,777
|
)
|
|
|
Six Months Ended June 30,
|
||||||
|
|
2020
|
|
2019
|
||||
|
|
|
|
|
||||
Cash flows from operating activities:
|
|
|
|
|
|
|
||
Net income (loss)
|
|
$
|
30,009
|
|
|
$
|
(21,623
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|
|
|
|
|
|
||
Depreciation and amortization
|
|
975
|
|
|
1,064
|
|
||
Loss on disposal of property and equipment
|
|
—
|
|
|
478
|
|
||
Remeasurement of acquisition-related contingent consideration
|
|
3,396
|
|
|
1,757
|
|
||
Remeasurement of financing-related contingent consideration
|
|
435
|
|
|
357
|
|
||
Amortization of debt discount and debt issuance costs
|
|
3,193
|
|
|
2,918
|
|
||
Change in deferred tax and income tax deferred charge
|
|
161
|
|
|
1,900
|
|
||
Stock-based compensation expense
|
|
1,511
|
|
|
406
|
|
||
Gain on the disposition of the hospital business
|
|
(45,760
|
)
|
|
—
|
|
||
Loss on deconsolidation of subsidiary
|
|
—
|
|
|
1,750
|
|
||
Other adjustments
|
|
477
|
|
|
(995
|
)
|
||
Net changes in assets and liabilities
|
|
|
|
|
|
|
||
Accounts receivable
|
|
2,589
|
|
|
579
|
|
||
Inventories
|
|
(1,353
|
)
|
|
2,124
|
|
||
Prepaid expenses and other current assets
|
|
(1,149
|
)
|
|
(1,829
|
)
|
||
Research and development tax credit receivable
|
|
2,036
|
|
|
(593
|
)
|
||
Accounts payable & other current liabilities
|
|
(1,550
|
)
|
|
3,127
|
|
||
Accrued expenses
|
|
(6,906
|
)
|
|
(3,737
|
)
|
||
Accrued income taxes
|
|
321
|
|
|
(71
|
)
|
||
Earn-out payments for contingent consideration in excess of acquisition-date fair value
|
|
(3,736
|
)
|
|
(5,790
|
)
|
||
Royalty payments for contingent consideration payable in excess of original fair value
|
|
(608
|
)
|
|
(917
|
)
|
||
Other assets and liabilities
|
|
(3,458
|
)
|
|
(3,558
|
)
|
||
Net cash used in operating activities
|
|
(19,417
|
)
|
|
(22,653
|
)
|
||
|
|
|
|
|
||||
Cash flows from investing activities:
|
|
|
|
|
|
|
||
Purchases of property and equipment
|
|
—
|
|
|
(29
|
)
|
||
Proceeds from the disposal of property and equipment
|
|
—
|
|
|
154
|
|
||
Proceeds from the disposition of the hospital business
|
|
14,500
|
|
|
—
|
|
||
Proceeds from sales of marketable securities
|
|
15,716
|
|
|
52,202
|
|
||
Purchases of marketable securities
|
|
(97,878
|
)
|
|
(21,991
|
)
|
||
Net cash (used in) provided by investing activities
|
|
(67,662
|
)
|
|
30,336
|
|
||
|
|
|
|
|
||||
Cash flows from financing activities:
|
|
|
|
|
|
|
||
Proceeds from the February 2020 private placement
|
|
60,639
|
|
|
—
|
|
||
Proceeds from the May 2020 public offering
|
|
116,974
|
|
|
—
|
|
||
Proceeds from stock option exercises and ESPP
|
|
1,903
|
|
|
92
|
|
||
Other financing activities, net
|
|
—
|
|
|
(37
|
)
|
||
Net cash provided by financing activities
|
|
179,516
|
|
|
55
|
|
||
|
|
|
|
|
||||
Effect of foreign currency exchange rate changes on cash and cash equivalents
|
|
(37
|
)
|
|
48
|
|
||
|
|
|
|
|
||||
Net change in cash and cash equivalents
|
|
92,400
|
|
|
7,786
|
|
||
Cash and cash equivalents at January 1,
|
|
9,774
|
|
|
9,325
|
|
||
Cash and cash equivalents at June 30,
|
|
$
|
102,174
|
|
|
$
|
17,111
|
|
|
|
|
|
|
||||
Supplemental disclosures of cash flow information:
|
|
|
|
|
||||
Interest paid
|
|
$
|
3,234
|
|
|
$
|
3,234
|
|
Income taxes (refund) paid, net
|
|
$
|
(1,795
|
)
|
|
$
|
140
|
|
•
|
Bloxiverz (neostigmine methylsulfate injection) - Bloxiverz was approved by the FDA in May 2013 and was launched in July 2013. Bloxiverz is a drug used intravenously in the operating room to reverse the effects of non-depolarizing neuromuscular blocking agents after surgery. Bloxiverz was the first FDA-approved version of neostigmine methylsulfate. Today, neostigmine is one of the two most frequently used products for the reversal of the effects of other agents used for neuromuscular blocks.
|
•
|
Vazculep (phenylephrine hydrochloride injection) - Vazculep was approved by the FDA in June 2014 and was launched in October 2014. Vazculep is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
|
•
|
Akovaz (ephedrine sulfate injection) - Akovaz, was approved by the FDA in April 2016 and was launched in August 2016. Akovaz was the first FDA approved formulation of ephedrine sulfate, an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
|
|
|
June 30, 2020
|
||
Prepaid expenses and other current assets
|
|
$
|
(134
|
)
|
Inventories
|
|
(4,922
|
)
|
|
Goodwill
|
|
(1,654
|
)
|
|
Intangible assets, net
|
|
(407
|
)
|
|
Other non-current assets
|
|
(1,095
|
)
|
|
Total long-term contingent consideration payable
|
|
14,900
|
|
|
Net liabilities disposed of
|
|
6,688
|
|
|
Aggregate consideration
|
|
42,000
|
|
|
Less transaction fees
|
|
(2,928
|
)
|
|
Net gain on the sale of the hospital business
|
|
$
|
45,760
|
|
•
|
Income approach, which is based on the present value of a future stream of net cash flows.
|
•
|
Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities.
|
•
|
Level 1 - Quoted prices for identical assets or liabilities in active markets.
|
•
|
Level 2 - Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means.
|
•
|
Level 3 - Unobservable inputs that reflect estimates and assumptions.
|
|
|
As of June 30, 2020
|
|
As of December 31, 2019
|
||||||||||||||||||||
Fair Value Measurements:
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Marketable securities (see Note 7)
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Equity securities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,404
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Money market and mutual funds
|
|
98,848
|
|
|
—
|
|
|
—
|
|
|
38,799
|
|
|
—
|
|
|
—
|
|
||||||
Corporate bonds
|
|
—
|
|
|
8,892
|
|
|
—
|
|
|
—
|
|
|
4,098
|
|
|
—
|
|
||||||
Government securities - U.S.
|
|
—
|
|
|
26,740
|
|
|
—
|
|
|
—
|
|
|
5,446
|
|
|
—
|
|
||||||
Other fixed-income securities
|
|
—
|
|
|
1,900
|
|
|
—
|
|
|
—
|
|
|
1,637
|
|
|
—
|
|
||||||
Total assets
|
|
$
|
98,848
|
|
|
$
|
37,532
|
|
|
$
|
—
|
|
|
$
|
43,203
|
|
|
$
|
11,181
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Contingent consideration payable (see Note 10)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,914
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17,327
|
|
Total liabilities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,914
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
17,327
|
|
|
|
June 30, 2020
|
||||||||||||||
Marketable Securities:
|
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Money market and mutual funds
|
|
$
|
98,024
|
|
|
$
|
824
|
|
|
$
|
—
|
|
|
$
|
98,848
|
|
Corporate bonds
|
|
8,720
|
|
|
180
|
|
|
(8
|
)
|
|
8,892
|
|
||||
Government securities - U.S.
|
|
26,424
|
|
|
317
|
|
|
(1
|
)
|
|
26,740
|
|
||||
Other fixed-income securities
|
|
1,867
|
|
|
33
|
|
|
—
|
|
|
1,900
|
|
||||
Total
|
|
$
|
135,035
|
|
|
$
|
1,354
|
|
|
$
|
(9
|
)
|
|
$
|
136,380
|
|
|
|
December 31, 2019
|
||||||||||||||
Marketable Securities:
|
|
Adjusted Cost
|
|
Unrealized Gains
|
|
Unrealized Losses
|
|
Fair Value
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Equity securities
|
|
$
|
4,234
|
|
|
$
|
170
|
|
|
$
|
—
|
|
|
$
|
4,404
|
|
Money market and mutual funds
|
|
38,028
|
|
|
771
|
|
|
—
|
|
|
38,799
|
|
||||
Corporate bonds
|
|
4,021
|
|
|
77
|
|
|
—
|
|
|
4,098
|
|
||||
Government securities - U.S.
|
|
5,341
|
|
|
110
|
|
|
(5
|
)
|
|
5,446
|
|
||||
Other fixed-income securities
|
|
1,614
|
|
|
23
|
|
|
—
|
|
|
1,637
|
|
||||
Total
|
|
$
|
53,238
|
|
|
$
|
1,151
|
|
|
$
|
(5
|
)
|
|
$
|
54,384
|
|
|
|
Maturities
|
||||||||||||||||||
Marketable Debt Securities:
|
|
Less than 1 Year
|
|
1-5 Years
|
|
5-10 Years
|
|
Greater than 10 Years
|
|
Total
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Corporate bonds
|
|
$
|
1,270
|
|
|
$
|
6,350
|
|
|
$
|
1,272
|
|
|
$
|
—
|
|
|
$
|
8,892
|
|
Government securities - U.S.
|
|
—
|
|
|
25,965
|
|
|
320
|
|
|
455
|
|
|
26,740
|
|
|||||
Other fixed-income securities
|
|
51
|
|
|
1,849
|
|
|
—
|
|
|
—
|
|
|
1,900
|
|
|||||
Total
|
|
$
|
1,321
|
|
|
$
|
34,164
|
|
|
$
|
1,592
|
|
|
$
|
455
|
|
|
$
|
37,532
|
|
Marketable Debt Securities:
|
|
Fair Value
|
|
Unrealized Losses
|
||||
|
|
|
|
|
||||
Corporate bonds
|
|
$
|
3,187
|
|
|
$
|
7
|
|
Other fixed-income securities
|
|
506
|
|
|
1
|
|
||
Total
|
|
$
|
3,693
|
|
|
$
|
8
|
|
Inventory:
|
|
June 30, 2020
|
|
December 31, 2019
|
||||
|
|
|
|
|
||||
Finished goods
|
|
$
|
—
|
|
|
$
|
3,020
|
|
Raw materials
|
|
—
|
|
|
550
|
|
||
Total
|
|
$
|
—
|
|
|
$
|
3,570
|
|
|
|
June 30, 2020
|
|
December 31, 2019
|
||||||||||||||||||||
Goodwill and Intangible Assets:
|
|
Gross
Value
|
|
Accumulated
Amortization
|
|
Net Carrying
Amount
|
|
Gross
Value
|
|
Accumulated
Amortization
|
|
Net Carrying
Amount
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Amortizable intangible assets - Acquired developed technology - Vazculep (1)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
12,061
|
|
|
$
|
(11,248
|
)
|
|
$
|
813
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unamortizable intangible assets - Goodwill (2)
|
|
$
|
16,836
|
|
|
$
|
—
|
|
|
$
|
16,836
|
|
|
$
|
18,491
|
|
|
$
|
—
|
|
|
$
|
18,491
|
|
|
|
|
Activity during the six months ended
June 30, 2020
|
|
|
||||||||||||||||||
|
|
|
|
|
Changes in Fair Value of Contingent Consideration Payable
|
|
|
|
|
||||||||||||||
Contingent Consideration Payable:
|
Balance,
December 31, 2019
|
|
Payments
|
|
Operating Expense
|
|
Other
Expense
|
|
Disposition of the Hospital Business
|
|
Balance, June 30, 2020
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Acquisition-related contingent consideration:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Earn-out payments - Éclat Pharmaceuticals (a) (d)
|
$
|
15,472
|
|
|
$
|
(3,736
|
)
|
|
$
|
3,396
|
|
|
$
|
—
|
|
|
(13,476
|
)
|
|
$
|
1,656
|
|
|
Financing-related:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Royalty agreement - Deerfield (b) (d)
|
1,251
|
|
|
(412
|
)
|
|
—
|
|
|
272
|
|
|
(936
|
)
|
|
175
|
|
||||||
Royalty agreement - Broadfin (c) (d)
|
604
|
|
|
(196
|
)
|
|
—
|
|
|
163
|
|
|
(488
|
)
|
|
83
|
|
||||||
Total contingent consideration payable
|
17,327
|
|
|
$
|
(4,344
|
)
|
|
$
|
3,396
|
|
|
$
|
435
|
|
|
$
|
(14,900
|
)
|
|
1,914
|
|
||
Less: current portion
|
(5,554
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,914
|
)
|
|||||||
Long-term contingent consideration payable
|
$
|
11,773
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
—
|
|
|
|
|
Activity during the three months ended
June 30, 2020
|
|
|
||||||||||||||||||
|
|
|
|
|
Changes in Fair Value of Contingent Consideration Payable
|
|
|
|
|
||||||||||||||
Contingent Consideration Payable:
|
Balance,
March 31, 2020
|
|
Payments
|
|
Operating Expense
|
|
Other
Expense
|
|
Disposition of the Hospital Business
|
|
Balance, June 30, 2020
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Acquisition-related contingent consideration:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Earn-out payments - Éclat Pharmaceuticals (a) (d)
|
$
|
16,176
|
|
|
$
|
(1,962
|
)
|
|
$
|
918
|
|
|
$
|
—
|
|
|
(13,476
|
)
|
|
$
|
1,656
|
|
|
Financing-related:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Royalty agreement - Deerfield (b) (d)
|
1,242
|
|
|
(215
|
)
|
|
—
|
|
|
84
|
|
|
(936
|
)
|
|
175
|
|
||||||
Royalty agreement - Broadfin (c) (d)
|
632
|
|
|
(102
|
)
|
|
—
|
|
|
41
|
|
|
(488
|
)
|
|
83
|
|
||||||
Total contingent consideration payable
|
18,050
|
|
|
$
|
(2,279
|
)
|
|
$
|
918
|
|
|
$
|
125
|
|
|
$
|
(14,900
|
)
|
|
1,914
|
|
||
Less: current portion
|
(5,855
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,914
|
)
|
|||||||
Long-term contingent consideration payable
|
$
|
12,195
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
—
|
|
(b)
|
As part of a February 2013 debt financing transaction conducted with Deerfield, the Company received cash of $2,600 in exchange for entering into a royalty agreement whereby the Company is obligated to pay quarterly a 1.75% royalty on the net sales of certain Éclat products until December 31, 2024. In connection with such debt financing transaction, the Company granted Deerfield a security interest in the product registration rights of the Éclat products. In connection with the disposition of the hospital business on June 30, 2020 as discussed in Note 4: Disposition of the Hospital Business, the Deerfield MIPA (with respect to certain sections thereof) and the Royalty Agreement were assigned to the Exela Buyer. Pursuant to the Purchase Agreement, the Exela Buyer assumed and will pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy and the Company under the Deerfield Royalty Agreement.
|
(c)
|
As part of a December 2013 debt financing transaction conducted with Broadfin Healthcare Master Fund, a former related party and shareholder, the Company received cash of $2,200 in exchange for entering into a royalty agreement whereby the Company is obligated to pay quarterly a 0.834% royalty on the net sales of certain Éclat products until December 31, 2024. In connection with the disposition of the hospital business on June 30, 2020 as discussed in Note 4: Disposition of the Hospital Business, the Broadfin Royalty Agreement was assigned to the Exela Buyer and the Exela Buyer assumed and shall pay, perform, satisfy and discharge the liabilities and obligations of the Company under the Broadfin Royalty Agreement.
|
(d)
|
Deerfield and Broadfin Healthcare Master Trust disposed of their 2023 Notes and ordinary shares in the Company during the six months ended June 30, 2020 and are no longer considered related parties.
|
Contingent Consideration Payable Rollforward:
|
|
Balance
|
||
|
|
|
||
Balance, December 31, 2018
|
|
$
|
28,840
|
|
Payments of contingent consideration
|
|
(6,707
|
)
|
|
Fair value adjustments (1)
|
|
2,114
|
|
|
Balance, June 30, 2019
|
|
$
|
24,247
|
|
|
|
|
||
Balance, December 31, 2019
|
|
$
|
17,327
|
|
Payments of contingent consideration
|
|
(4,344
|
)
|
|
Fair value adjustments (1)
|
|
3,831
|
|
|
Disposition of the hospital business
|
|
(14,900
|
)
|
|
Balance, June 30, 2020
|
|
$
|
1,914
|
|
|
|
June 30, 2020
|
|
December 31, 2019
|
||||
Principal amount of 4.50% exchangeable senior notes due 2023
|
|
$
|
143,750
|
|
|
$
|
143,750
|
|
Less: unamortized debt discount and issuance costs, net
|
|
(18,871
|
)
|
|
(22,064
|
)
|
||
Net carrying amount of liability component
|
|
124,879
|
|
|
121,686
|
|
||
Less: current maturities
|
|
—
|
|
|
—
|
|
||
Long-term debt
|
|
$
|
124,879
|
|
|
$
|
121,686
|
|
|
|
|
|
|
||||
Equity component:
|
|
|
|
|
||||
Equity component of exchangeable notes, net of issuance costs
|
|
$
|
(26,699
|
)
|
|
$
|
(26,699
|
)
|
Prepaid Expenses and Other Current Assets:
|
|
June 30, 2020
|
|
December 31, 2019
|
||||
|
|
|
|
|
||||
Valued-added tax recoverable
|
|
$
|
266
|
|
|
$
|
1,051
|
|
Prepaid and other expenses
|
|
4,154
|
|
|
2,116
|
|
||
Guarantee from Armistice
|
|
410
|
|
|
454
|
|
||
Income tax receivable
|
|
149
|
|
|
536
|
|
||
Short term note receivable from Exela (see Note 4)
|
|
27,500
|
|
|
—
|
|
||
Other
|
|
294
|
|
|
107
|
|
||
Total
|
|
$
|
32,773
|
|
|
$
|
4,264
|
|
Other Non-Current Assets:
|
|
June 30, 2020
|
|
December 31, 2019
|
||||
|
|
|
|
|
||||
Deferred tax assets, net
|
|
$
|
29,180
|
|
|
$
|
29,427
|
|
Long-term deposits
|
|
1,477
|
|
|
1,477
|
|
||
Guarantee from Armistice
|
|
1,184
|
|
|
1,367
|
|
||
Right of use assets at contract manufacturing organizations
|
|
5,201
|
|
|
6,428
|
|
||
Other
|
|
573
|
|
|
575
|
|
||
Total
|
|
$
|
37,615
|
|
|
$
|
39,274
|
|
Accrued Expenses
|
|
June 30, 2020
|
|
December 31, 2019
|
||||
|
|
|
|
|
||||
Accrued compensation
|
|
$
|
1,432
|
|
|
$
|
3,944
|
|
Accrued social charges
|
|
219
|
|
|
592
|
|
||
Accrued restructuring (see Note 14)
|
|
1,009
|
|
|
2,949
|
|
||
Customer allowances
|
|
5,901
|
|
|
6,470
|
|
||
Accrued transaction fees related to the disposition of the hospital business
|
|
2,928
|
|
|
—
|
|
||
Accrued contract research organization charges
|
|
1,692
|
|
|
2,098
|
|
||
Accrued contract manufacturing organization costs
|
|
260
|
|
|
735
|
|
||
Other
|
|
2,379
|
|
|
3,022
|
|
||
Total
|
|
$
|
15,820
|
|
|
$
|
19,810
|
|
Other Non-Current Liabilities:
|
|
June 30, 2020
|
|
December 31, 2019
|
||||
|
|
|
|
|
||||
Customer allowances
|
|
$
|
946
|
|
|
$
|
981
|
|
Unrecognized tax benefits
|
|
3,143
|
|
|
6,465
|
|
||
Guarantee to Deerfield
|
|
1,188
|
|
|
1,372
|
|
||
Other
|
|
15
|
|
|
55
|
|
||
Total
|
|
$
|
5,292
|
|
|
$
|
8,873
|
|
(a)
|
up to $250,000 in aggregate of ordinary shares, nominal value US$0.01 per share (the “Ordinary Shares”), each of which may be represented by American Depositary Shares (“ADSs”), preferred shares, nominal value US$0.01 per share (the “Preferred Shares”), debt securities (the “Debt Securities”), warrants to purchase Ordinary Shares, ADSs, Preferred Shares and/or Debt Securities (the “Warrants”), and/or units consisting of Ordinary Shares, ADSs, Preferred Shares, one or more Debt Securities or Warrants in one or more series, in any combination, pursuant to the terms of the 2020 Shelf Registration Statement, the base prospectus contained in the 2020 Shelf Registration Statement (the “Base Prospectus”), and any amendments or supplements thereto (together, the “Securities”); including
|
(b)
|
up to $50,000 of ADSs that may be issued and sold from time to time pursuant to the terms of an Open Market Sale AgreementSM (“the Sales Agreement”), entered into with Jefferies LLC on February 4, 2020 (the “Sales Agreement”), the 2020 Shelf Registration Statement, the Base Prospectus and the terms of the sales agreement prospectus contained in the 2020 Shelf Registration Statement.
|
2019 French Restructuring Obligation:
|
|
2020
|
|
2019
|
||||
|
|
|
|
|
||||
Balance of restructuring accrual at January 1,
|
|
$
|
1,922
|
|
|
$
|
—
|
|
Charges for employee severance, benefits and other costs
|
|
173
|
|
|
2,414
|
|
||
Payments
|
|
(1,784
|
)
|
|
(1,332
|
)
|
||
Foreign currency impact
|
|
(48
|
)
|
|
20
|
|
||
Balance of restructuring accrual at June 30,
|
|
$
|
263
|
|
|
$
|
1,102
|
|
2019 Corporate Restructuring Obligation:
|
|
2020
|
|
2019
|
||||
|
|
|
|
|
||||
Balance of restructuring accrual at January 1,
|
|
$
|
1,080
|
|
|
$
|
—
|
|
Charges for employee severance, benefits and other costs
|
|
106
|
|
|
2,359
|
|
||
Payments
|
|
(440
|
)
|
|
(2,016
|
)
|
||
Balance of restructuring accrual at June 30,
|
|
$
|
746
|
|
|
$
|
343
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
Net Income (Loss) Per Share:
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Net income (loss)
|
|
$
|
30,874
|
|
|
$
|
(8,605
|
)
|
|
$
|
30,009
|
|
|
$
|
(21,623
|
)
|
Add: interest from 2023 Notes, net of tax
|
|
3,237
|
|
|
—
|
|
|
6,427
|
|
|
—
|
|
||||
Net income (loss) - diluted
|
|
$
|
34,111
|
|
|
$
|
(8,605
|
)
|
|
$
|
36,436
|
|
|
$
|
(21,623
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
Weighted average shares:
|
|
|
|
|
|
|
|
|
|
|
||||||
Basic shares
|
|
54,272
|
|
|
37,356
|
|
|
47,665
|
|
|
37,355
|
|
||||
Effect of dilutive securities—employee and director equity awards outstanding, preferred shares and 2023 Notes
|
|
15,670
|
|
|
—
|
|
|
15,418
|
|
|
—
|
|
||||
Diluted shares
|
|
69,942
|
|
|
37,356
|
|
|
63,083
|
|
|
37,355
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Net income (loss) per share - basic
|
|
$
|
0.57
|
|
|
$
|
(0.23
|
)
|
|
$
|
0.63
|
|
|
$
|
(0.58
|
)
|
Net income (loss) per share - diluted
|
|
$
|
0.49
|
|
|
$
|
(0.23
|
)
|
|
$
|
0.58
|
|
|
$
|
(0.58
|
)
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
Accumulated Other Comprehensive Loss:
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Foreign currency translation adjustment:
|
|
|
|
|
|
|
|
|
|
|
||||||
Beginning balance
|
|
$
|
(23,915
|
)
|
|
$
|
(23,782
|
)
|
|
$
|
(23,738
|
)
|
|
$
|
(23,621
|
)
|
Net other comprehensive income (loss)
|
|
182
|
|
|
62
|
|
|
5
|
|
|
(99
|
)
|
||||
Balance at June 30,
|
|
$
|
(23,733
|
)
|
|
$
|
(23,720
|
)
|
|
$
|
(23,733
|
)
|
|
$
|
(23,720
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
Unrealized gain on marketable debt securities, net
|
|
|
|
|
|
|
|
|
|
|
||||||
Beginning balance
|
|
$
|
288
|
|
|
$
|
579
|
|
|
$
|
932
|
|
|
$
|
205
|
|
Net other comprehensive income, net of ($81), ($23), ($130) and ($41) tax, respectively
|
|
927
|
|
|
293
|
|
|
283
|
|
|
667
|
|
||||
Balance at June 30,
|
|
$
|
1,215
|
|
|
$
|
872
|
|
|
$
|
1,215
|
|
|
$
|
872
|
|
Accumulated other comprehensive loss at June 30,
|
|
$
|
(22,518
|
)
|
|
$
|
(22,848
|
)
|
|
$
|
(22,518
|
)
|
|
$
|
(22,848
|
)
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
Product Sales by Product:
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
||||||||
|
|
|
|
|
|
|
|
|
||||||||
Bloxiverz
|
|
$
|
800
|
|
|
$
|
2,358
|
|
|
$
|
2,201
|
|
|
$
|
4,926
|
|
Vazculep
|
|
4,915
|
|
|
9,410
|
|
|
10,429
|
|
|
18,883
|
|
||||
Akovaz
|
|
4,196
|
|
|
5,946
|
|
|
9,545
|
|
|
9,738
|
|
||||
Other
|
|
180
|
|
|
(160
|
)
|
|
159
|
|
|
444
|
|
||||
Total product sales
|
|
$
|
10,091
|
|
|
$
|
17,554
|
|
|
$
|
22,334
|
|
|
$
|
33,991
|
|
•
|
Bloxiverz (neostigmine methylsulfate injection) - Bloxiverz was approved by the FDA in May 2013 and was launched in July 2013. Bloxiverz is a drug used intravenously in the operating room to reverse the effects of non-depolarizing neuromuscular blocking agents after surgery. Bloxiverz was the first FDA-approved version of neostigmine methylsulfate. Today, neostigmine is one of the two most frequently used products for the reversal of the effects of other agents used for neuromuscular blocks. There are approximately 2,500 vials of neostigmine sold annually in the U.S.
|
•
|
Vazculep (phenylephrine hydrochloride injection) - Vazculep was approved by the FDA in June 2014 and was launched in October 2014. Vazculep is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. There are approximately 7,400 vials of Vazculep sold annually in the U.S.
|
•
|
Akovaz (ephedrine sulfate injection) - Akovaz, was approved by the FDA in April 2016 and was launched in August 2016. Akovaz was the first FDA approved formulation of ephedrine sulfate, an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. There are approximately 6,800 vials of Akovaz sold annually in the U.S.
|
•
|
Healthcare and Regulatory Reform: Various health care reform laws in the U.S. may impact our ability to successfully commercialize our products and technologies. The success of our commercialization efforts may depend on the extent to which the government health administration authorities, the health insurance funds in the E.U. Member States, private health insurers and other third-party payers in the U.S. will reimburse consumers for the cost of healthcare products and services.
|
•
|
Competition and Technological Change: Competition in the pharmaceutical and biotechnology industry continues to be intense and is expected to increase. We compete with academic laboratories, research institutions, universities, joint ventures, and other pharmaceutical and biotechnology companies, including other companies developing niche branded or generic specialty pharmaceutical products or drug delivery platforms. Furthermore, major technological changes can happen quickly in the pharmaceutical and biotechnology industries. Such rapid technological change, or the development by our competitors of technologically improved or differentiated products, could render our drug delivery platforms obsolete or noncompetitive.
|
•
|
Pricing Environment for Pharmaceuticals: The pricing environment continues to be in the political spotlight in the U.S. As a result, the need to obtain and maintain appropriate pricing for our products may become more challenging due to, among other things, the attention being paid to healthcare cost containment and other austerity measures in the U.S. and worldwide.
|
•
|
Generics Playing a Larger Role in Healthcare: Generic pharmaceutical products will continue to play a large role in the U.S. healthcare system. Specifically, we have seen, or likely will see, additional generic competition to our current and future products and we continue to expect generic competition in the future.
|
•
|
Access to and Cost of Capital: The process of raising capital and associated cost of such capital for a company of our financial profile can be difficult and potentially expensive. If the need were to arise to raise additional capital, access to that capital may be difficult and/or expensive and, as a result, could create liquidity challenges for the Company.
|
•
|
Net Loss from Operations in 2020: Since we sold our hospital products at June 30, 2020 and will no longer generate revenue from sales and we will incur substantial expenses to further the clinical development of FT218, we expect to incur a net loss in 2020, which we are unable to estimate at this time.
|
•
|
Revenue was $10,091 and $22,334 for the three and six months ended June 30, 2020, respectively, compared to $17,554 and $33,991 in the same period last year, respectively. This year over year decrease was primarily the result of increased competition driving lower prices as noted above in our discussion of Key Business Trends and Highlights. Our Bloxiverz and Vazculep products experienced price and unit volume declines due to additional competition.
|
•
|
Operating income was $40,269 and $33,772 for the three and six months ended June 30, 2020, respectively, compared to an operating loss of $4,451 and $12,618 and for the same period last year, respectively. The increase in operating income for the three months ended June 30, 2020 was driven the gain on the disposition of hospital products of $45,760 and lower research and development (“R&D”) expense of $6,235, partially offset by a decline in gross margin (i.e., total revenues minus cost of products) of $7,126. The increase in operating income for the six months ended June 30, 2020 was driven by the gain on the disposition of hospital products of $45,760, lower R&D expense of $8,034, lower restructuring costs of $2,551, partially offset by lower gross margin of $10,511.
|
•
|
Gain on the disposition of the hospital business was $45,760 for the three and six months ended June 30, 2020. The net gain included sale proceeds of $42,000 ($27,500 recorded as a current note receivable), write-off of our inventory, intangible asset, a portion of goodwill and other related assets of $8,212, estimated transaction fees of $2,928 and the reversal of our contingent consideration liability of $14,900.
|
•
|
Net income was $30,874 and $30,009 for the three and six months ended June 30, 2020, respectively, compared to net loss of $8,605 and $21,623 in the same period last year, respectively. Included in the net income during the three and six months ended June 30, 2020 was a gain on the disposition of the hospital business of $45,760.
|
•
|
Diluted net income per share was $0.49 and $0.58 for the three and six months ended June 30, 2020, respectively, compared to diluted net loss per share of $0.23 and $0.58 in the same period last year, respectively.
|
•
|
Cash and marketable securities increased $174,396 to $238,554 at June 30, 2020, from $64,158 at December 31, 2019. This increase was driven by the February private placement which resulted in proceeds, net of placement fees of approximately $61,000, the May public offering, which resulted in proceeds, net of placement fees of approximately $117,000, cash proceeds from the disposition of the hospital business of $14,500, partially offset by $19,417 use of cash in operations during the six months ended June 30, 2020.
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Comparative Statements of Income (loss)
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Product sales
|
|
$
|
10,091
|
|
|
$
|
17,554
|
|
|
$
|
(7,463
|
)
|
|
(42.5
|
)%
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|||||
Cost of products
|
|
3,285
|
|
|
3,622
|
|
|
(337
|
)
|
|
(9.3
|
)%
|
|||
Research and development expenses
|
|
4,057
|
|
|
10,292
|
|
|
(6,235
|
)
|
|
(60.6
|
)%
|
|||
Selling, general and administrative expenses
|
|
7,095
|
|
|
6,758
|
|
|
337
|
|
|
5.0
|
%
|
|||
Intangible asset amortization
|
|
203
|
|
|
204
|
|
|
(1
|
)
|
|
(0.5
|
)%
|
|||
Changes in fair value of contingent consideration
|
|
918
|
|
|
(377
|
)
|
|
1,295
|
|
|
343.5
|
%
|
|||
Gain on sale of hospital business
|
|
(45,760
|
)
|
|
—
|
|
|
(45,760
|
)
|
|
(100.0
|
)%
|
|||
Restructuring costs
|
|
24
|
|
|
1,506
|
|
|
(1,482
|
)
|
|
(98.4
|
)%
|
|||
Total operating (income) expense
|
|
(30,178
|
)
|
|
22,005
|
|
|
(52,183
|
)
|
|
(237.1
|
)%
|
|||
Operating income (loss)
|
|
40,269
|
|
|
(4,451
|
)
|
|
44,720
|
|
|
1,004.7
|
%
|
|||
Investment and other income, net
|
|
(741
|
)
|
|
950
|
|
|
(1,691
|
)
|
|
(178.0
|
)%
|
|||
Interest expense
|
|
(3,237
|
)
|
|
(3,106
|
)
|
|
(131
|
)
|
|
(4.2
|
)%
|
|||
Loss on deconsolidation of subsidiary
|
|
—
|
|
|
(167
|
)
|
|
167
|
|
|
100.0
|
%
|
|||
Other expense - changes in fair value of contingent consideration payable
|
|
(125
|
)
|
|
(50
|
)
|
|
(75
|
)
|
|
(150.0
|
)%
|
|||
Income (loss) before income taxes
|
|
36,166
|
|
|
(6,824
|
)
|
|
42,990
|
|
|
630.0
|
%
|
|||
Income tax benefit
|
|
5,292
|
|
|
1,781
|
|
|
3,511
|
|
|
197.1
|
%
|
|||
Net income (loss)
|
|
$
|
30,874
|
|
|
$
|
(8,605
|
)
|
|
$
|
39,479
|
|
|
458.8
|
%
|
Net income (loss) per share - diluted
|
|
$
|
0.49
|
|
|
$
|
(0.23
|
)
|
|
$
|
0.72
|
|
|
313.0
|
%
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Comparative Statements of Income (Loss)
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Product sales
|
|
$
|
22,334
|
|
|
$
|
33,991
|
|
|
$
|
(11,657
|
)
|
|
(34.3
|
)%
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|||||
Cost of products
|
|
5,742
|
|
|
6,888
|
|
|
(1,146
|
)
|
|
(16.6
|
)%
|
|||
Research and development expenses
|
|
9,587
|
|
|
17,621
|
|
|
(8,034
|
)
|
|
(45.6
|
)%
|
|||
Selling, general and administrative expenses
|
|
15,008
|
|
|
17,204
|
|
|
(2,196
|
)
|
|
(12.8
|
)%
|
|||
Intangible asset amortization
|
|
406
|
|
|
405
|
|
|
1
|
|
|
0.2
|
%
|
|||
Changes in fair value of contingent consideration
|
|
3,396
|
|
|
1,757
|
|
|
1,639
|
|
|
93.3
|
%
|
|||
Gain on sale of hospital business
|
|
(45,760
|
)
|
|
—
|
|
|
(45,760
|
)
|
|
(100.0
|
)%
|
|||
Restructuring costs
|
|
183
|
|
|
2,734
|
|
|
(2,551
|
)
|
|
(93.3
|
)%
|
|||
Total operating (income) expense
|
|
(11,438
|
)
|
|
46,609
|
|
|
(58,047
|
)
|
|
(124.5
|
)%
|
|||
Operating income (loss)
|
|
33,772
|
|
|
(12,618
|
)
|
|
46,390
|
|
|
367.6
|
%
|
|||
Investment and other (expense) income, net
|
|
(1,119
|
)
|
|
1,767
|
|
|
(2,886
|
)
|
|
(163.3
|
)%
|
|||
Interest expense
|
|
(6,427
|
)
|
|
(6,168
|
)
|
|
(259
|
)
|
|
(4.2
|
)%
|
|||
Loss on deconsolidation of subsidiary
|
|
—
|
|
|
(2,840
|
)
|
|
2,840
|
|
|
100.0
|
%
|
|||
Other expense - changes in fair value of contingent consideration payable
|
|
(435
|
)
|
|
(357
|
)
|
|
(78
|
)
|
|
(21.8
|
)%
|
|||
Income (loss) before income taxes
|
|
25,791
|
|
|
(20,216
|
)
|
|
46,007
|
|
|
227.6
|
%
|
|||
Income tax (expense) benefit
|
|
(4,218
|
)
|
|
1,407
|
|
|
(5,625
|
)
|
|
(399.8
|
)%
|
|||
Net income (loss)
|
|
$
|
30,009
|
|
|
$
|
(21,623
|
)
|
|
$
|
51,632
|
|
|
238.8
|
%
|
Net income (loss) per share - diluted
|
|
$
|
0.58
|
|
|
$
|
(0.58
|
)
|
|
$
|
1.16
|
|
|
200.0
|
%
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Product sales:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Bloxiverz
|
|
$
|
800
|
|
|
$
|
2,358
|
|
|
(1,558
|
)
|
|
(66.1
|
)%
|
|
Vazculep
|
|
4,915
|
|
|
9,410
|
|
|
(4,495
|
)
|
|
(47.8
|
)%
|
|||
Akovaz
|
|
4,196
|
|
|
5,946
|
|
|
(1,750
|
)
|
|
(29.4
|
)%
|
|||
Other
|
|
180
|
|
|
(160
|
)
|
|
340
|
|
|
212.5
|
%
|
|||
Product sales
|
|
$
|
10,091
|
|
|
$
|
17,554
|
|
|
$
|
(7,463
|
)
|
|
(42.5
|
)%
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Product sales:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Bloxiverz
|
|
$
|
2,201
|
|
|
$
|
4,926
|
|
|
$
|
(2,725
|
)
|
|
(55.3
|
)%
|
Vazculep
|
|
10,429
|
|
|
18,883
|
|
|
(8,454
|
)
|
|
(44.8
|
)%
|
|||
Akovaz
|
|
9,545
|
|
|
9,738
|
|
|
(193
|
)
|
|
(2.0
|
)%
|
|||
Other
|
|
159
|
|
|
444
|
|
|
(285
|
)
|
|
(64.2
|
)%
|
|||
Product sales
|
|
$
|
22,334
|
|
|
$
|
33,991
|
|
|
$
|
(11,657
|
)
|
|
(34.3
|
)%
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Cost of Products:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Cost of products
|
|
$
|
3,285
|
|
|
$
|
3,622
|
|
|
$
|
(337
|
)
|
|
(9.3
|
)%
|
Percentage of total revenues
|
|
32.6
|
%
|
|
20.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Cost of Products:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Cost of products
|
|
$
|
5,742
|
|
|
$
|
6,888
|
|
|
$
|
(1,146
|
)
|
|
(16.6
|
)%
|
Percentage of total revenues
|
|
25.7
|
%
|
|
20.3
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||
|
|
|
2020 vs. 2019
|
||||||||||
Research and Development Expenses:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||
|
|
|
|
|
|
|
|
|
|||||
Research and development expenses
|
|
4,057
|
|
|
10,292
|
|
|
$
|
(6,235
|
)
|
|
(60.6
|
)%
|
Percentage of total revenues
|
|
40.2
|
%
|
|
58.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Research and Development Expenses:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Research and development expenses
|
|
$
|
9,587
|
|
|
$
|
17,621
|
|
|
$
|
(8,034
|
)
|
|
(45.6
|
)%
|
Percentage of total revenues
|
|
42.9
|
%
|
|
51.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Selling, General and Administrative Expenses:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Selling, general and administrative expenses
|
|
$
|
7,095
|
|
|
$
|
6,758
|
|
|
$
|
337
|
|
|
5.0
|
%
|
Percentage of total revenues
|
|
70.3
|
%
|
|
38.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Selling, General and Administrative Expenses:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Selling, general and administrative expenses
|
|
$
|
15,008
|
|
|
$
|
17,204
|
|
|
$
|
(2,196
|
)
|
|
(12.8
|
)%
|
Percentage of total revenues
|
|
67.2
|
%
|
|
50.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Intangibles Asset Amortization:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Intangible asset amortization
|
|
$
|
203
|
|
|
$
|
204
|
|
|
$
|
(1
|
)
|
|
(0.5
|
)%
|
Percentage of total revenues
|
|
2.0
|
%
|
|
1.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Intangibles Asset Amortization:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Intangible asset amortization
|
|
$
|
406
|
|
|
$
|
405
|
|
|
$
|
1
|
|
|
0.2
|
%
|
Percentage of total revenues
|
|
1.8
|
%
|
|
1.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Gain on Sale of Hospital Business
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Gain on sale of hospital business
|
|
$
|
45,760
|
|
|
$
|
—
|
|
|
$
|
45,760
|
|
|
100.0
|
%
|
Percentage of total revenues
|
|
453.5
|
%
|
|
—
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Gain on Sale of Hospital Business
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Gain on sale of hospital business
|
|
$
|
45,760
|
|
|
$
|
—
|
|
|
$
|
45,760
|
|
|
100.0
|
%
|
Percentage of total revenues
|
|
204.9
|
%
|
|
—
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Restructuring Costs
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Restructuring costs
|
|
$
|
24
|
|
|
$
|
1,506
|
|
|
$
|
(1,482
|
)
|
|
(98.4
|
)%
|
Percentage of total revenues
|
|
0.2
|
%
|
|
8.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Restructuring Costs
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Restructuring costs
|
|
$
|
183
|
|
|
$
|
2,734
|
|
|
$
|
(2,551
|
)
|
|
(93.3
|
)%
|
Percentage of total revenues
|
|
0.8
|
%
|
|
8.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Investment and Other (Expense) Income, net
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Investment and other (expense) income, net
|
|
$
|
(741
|
)
|
|
$
|
950
|
|
|
$
|
(1,691
|
)
|
|
(178.0
|
)%
|
Percentage of total revenues
|
|
(7.3
|
)%
|
|
5.4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Investment and Other (Expense) Income, net
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Investment and other (expense) income, net
|
|
$
|
(1,119
|
)
|
|
$
|
1,767
|
|
|
$
|
(2,886
|
)
|
|
(163.3
|
)%
|
Percentage of total revenues
|
|
(5.0
|
)%
|
|
5.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Interest Expense
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Interest expense
|
|
$
|
3,237
|
|
|
$
|
3,106
|
|
|
$
|
131
|
|
|
4.2
|
%
|
Percentage of total revenues
|
|
32.1
|
%
|
|
17.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Interest Expense
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Interest expense
|
|
$
|
6,427
|
|
|
$
|
6,168
|
|
|
$
|
259
|
|
|
4.2
|
%
|
Percentage of total revenues
|
|
28.8
|
%
|
|
18.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Loss on Deconsolidation of Subsidiary
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Loss on deconsolidation of subsidiary
|
|
$
|
—
|
|
|
$
|
(167
|
)
|
|
$
|
167
|
|
|
100.0
|
%
|
Percentage of total revenues
|
|
—
|
%
|
|
(1.0
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Loss on Deconsolidation of Subsidiary
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Loss on deconsolidation of subsidiary
|
|
$
|
—
|
|
|
$
|
(2,840
|
)
|
|
$
|
2,840
|
|
|
100.0
|
%
|
Percentage of total revenues
|
|
—
|
%
|
|
(8.4
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Other Expense - Changes in Fair Value of Contingent Consideration Payable
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Other expense - changes in fair value of contingent consideration payable
|
|
$
|
(125
|
)
|
|
$
|
(50
|
)
|
|
$
|
(75
|
)
|
|
(150.0
|
)%
|
Percentage of total revenues
|
|
(1.2
|
)%
|
|
(0.3
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Other Expense - Changes in Fair Value of Contingent Consideration Payable
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Other expense - changes in fair value of contingent consideration payable
|
|
$
|
(435
|
)
|
|
$
|
(357
|
)
|
|
$
|
(78
|
)
|
|
(21.8
|
)%
|
Percentage of total revenues
|
|
(1.9
|
)%
|
|
(1.1
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|||||||||
|
|
Three Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Income Tax Provision:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Income tax provision
|
|
$
|
5,292
|
|
|
$
|
1,781
|
|
|
$
|
3,511
|
|
|
197.1
|
%
|
Percentage of loss before income taxes
|
|
(14.6
|
)%
|
|
26.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Income Tax (Benefit) Provision:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Income tax (benefit) provision
|
|
$
|
(4,218
|
)
|
|
$
|
1,407
|
|
|
$
|
(5,625
|
)
|
|
(399.8
|
)%
|
Percentage of loss before income taxes
|
|
(16.4
|
)%
|
|
(6.8
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|||||||||
|
|
Six Months Ended June 30,
|
|
Increase / (Decrease)
|
|||||||||||
|
|
|
2020 vs. 2019
|
||||||||||||
Net cash (used in) provided by:
|
|
2020
|
|
2019
|
|
$
|
|
%
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||
Operating activities
|
|
$
|
(19,417
|
)
|
|
$
|
(22,653
|
)
|
|
$
|
3,236
|
|
|
14.3
|
%
|
Investing activities
|
|
(67,662
|
)
|
|
30,336
|
|
|
(97,998
|
)
|
|
(323.0
|
)%
|
|||
Financing activities
|
|
179,516
|
|
|
55
|
|
|
179,461
|
|
|
326,292.7
|
%
|
•
|
up to $250,000 in aggregate of ordinary shares, nominal value US$0.01 per share (the “Ordinary Shares”), each of which may be represented by ADSs, preferred shares, nominal value US$0.01 per share (the “Preferred Shares”), debt securities (the “Debt Securities”), warrants to purchase Ordinary Shares, ADSs, Preferred Shares and/or Debt Securities (the “Warrants”), and/or units consisting of Ordinary Shares, ADSs, Preferred Shares, one or more Debt Securities or Warrants in one or more series, in any combination, pursuant to the terms of the 2020 Shelf Registration Statement, the base
|
•
|
up to $50,000 of ADSs that may be issued and sold from time to time pursuant to the terms of an Open Market Sale AgreementSM (“the Sales Agreement”), entered into with Jefferies LLC on February 4, 2020, the 2020 Shelf Registration Statement, the Base Prospectus and the terms of the sales agreement prospectus contained in the 2020 Shelf Registration Statement.
|
ITEM 1.
|
LEGAL PROCEEDINGS.
|
Exhibit No.
|
|
Description
|
|
|
|
10.1
|
|
|
10.2+
|
|
|
31.1*
|
|
|
31.2*
|
|
|
32.1**
|
|
|
32.2**
|
|
|
101.SCH*
|
|
Inline XBRL Taxonomy Extension Schema Document
|
101.CAL*
|
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF*
|
|
Inline XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB*
|
|
Inline XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE*
|
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
104
|
|
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*) (filed herewith)
|
|
AVADEL PHARMACEUTICALS PLC
|
|
|
(Registrant)
|
|
|
|
|
Date: August 10, 2020
|
By:
|
/s/ Gregory J. Divis
|
|
|
Gregory J. Divis
|
|
|
Chief Executive Officer
|
|
|
(Duly Authorized Officer and Principal Executive Officer)
|
|
|
|
|
|
|
|
|
|
Date: August 10, 2020
|
By:
|
/s/ Thomas S. McHugh
|
|
|
Thomas S. McHugh
|
|
|
Senior Vice President and Chief Financial Officer
|
|
|
(Duly Authorized Officer and Principal Financial and Accounting Officer)
|
Date: August 10, 2020
|
/s/ Gregory J. Divis
|
|
Gregory J. Divis
|
|
Chief Executive Officer
|
Date: August 10, 2020
|
/s/ Thomas S. McHugh
|
|
Thomas S. McHugh
|
|
Senior Vice President and Chief Financial Officer
|
Date: August 10, 2020
|
/s/ Gregory J. Divis
|
|
Gregory J. Divis
|
|
Chief Executive Officer
|
Date: August 10, 2020
|
/s/ Thomas S. McHugh
|
|
Thomas S. McHugh
|
|
Senior Vice President and Chief Financial Officer
|