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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended
September 30,
2022
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from
to
Commission File No.
000-21392
Amarin Corporation plc
(Exact Name of Registrant as Specified in its Charter)
|
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England and Wales
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Not applicable
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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Iconic Offices, The Greenway,
Block C Ardilaun Court,
112 – 114 St Stephens Green
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Dublin
2,
Ireland
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(Address of Principal Executive Offices)
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(Zip Code)
|
Registrant’s telephone number, including area code:
+353
(0) 1
6699 020
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class
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Trading Symbol
|
Name of each exchange on which registered
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American Depositary Shares (ADS(s)), each ADS
representing the right to receive one (1) Ordinary Share
of
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AMRN
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NASDAQ Stock Market LLC
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Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90 days.
Yes
☒
No
☐
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
registrant was required to submit such files).
Yes
☒
No
☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company or an emerging growth company. See the
definitions of “large accelerated filer,” accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large accelerated filer
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☒
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Accelerated filer
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☐
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Non-accelerated filer
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☐
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Smaller reporting company
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☐
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Emerging growth company
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☐
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|
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Act).
Yes
☐
No
☒
403,828,955 common shares were outstanding as of October 21, 2022,
including
383,347,128
shares held as American Depositary Shares (ADSs), each representing
one Ordinary Share, 50 pence par value per share and
20,481,827
Ordinary Shares.
INDEX TO FORM 10-Q
2
PART
I
AMARIN CORPORATION PLC
CONDENSED CONSOLIDATED
BALANCE SHEETS
(Unaudited, in thousands, except share amounts)
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September 30, 2022
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December 31, 2021
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ASSETS
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Current Assets:
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Cash and cash equivalents
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$
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240,498
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$
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219,454
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Restricted cash
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3,920
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3,918
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Short-term investments
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63,203
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234,674
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Accounts receivable, net
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123,379
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163,653
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Inventory
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227,606
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234,676
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Prepaid and other current assets
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27,914
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|
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22,352
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Total current assets
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686,520
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878,727
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Property, plant and equipment, net
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999
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1,425
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Long-term investments
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2,264
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34,996
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Long-term inventory
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187,964
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121,254
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Operating lease right-of-use asset
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8,462
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|
|
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7,660
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Other long-term assets
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|
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456
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|
|
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456
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Intangible asset, net
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21,638
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|
|
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23,547
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TOTAL ASSETS
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$
|
908,303
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|
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$
|
1,068,065
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|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
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|
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Current Liabilities:
|
|
|
|
|
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Accounts payable
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$
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93,157
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|
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$
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114,922
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|
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Accrued expenses and other current liabilities
|
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192,001
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|
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253,111
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Current deferred revenue
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2,198
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|
|
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2,649
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Total current liabilities
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287,356
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|
|
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370,682
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Long-Term Liabilities:
|
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Long-term deferred revenue
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13,499
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14,060
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Long-term operating lease liability
|
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9,924
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|
|
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8,576
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|
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Other long-term liabilities
|
|
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9,697
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|
|
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7,648
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Total liabilities
|
|
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320,476
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|
|
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400,966
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|
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Commitments and contingencies (Note
5)
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Stockholders’ Equity:
|
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Common stock, £0.50 par,
unlimited authorized;
411,660,040 shares
issued,
403,828,955 shares
outstanding as of September 30, 2022;
404,084,775 shares
issued,
396,598,008 shares
outstanding as of December 31, 2021
|
|
|
298,596
|
|
|
|
294,027
|
|
|
Additional paid-in capital
|
|
|
1,878,923
|
|
|
|
1,855,246
|
|
|
Treasury stock;
7,831,085 shares
as of September 30, 2022;
7,486,767 shares
as of December 31, 2021
|
|
|
(61,585
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)
|
|
|
(60,726
|
)
|
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Accumulated deficit
|
|
|
(1,528,107
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)
|
|
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(1,421,448
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)
|
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Total stockholders’ equity
|
|
|
587,827
|
|
|
|
667,099
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|
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
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$
|
908,303
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|
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$
|
1,068,065
|
|
See notes to condensed consolidated financial
statements.
3
AMARIN CORPORATION PLC
CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS
(Unaudited, in thousands, except per share amounts)
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Three months ended September 30,
|
|
|
Nine months ended September 30,
|
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2022
|
|
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2021
|
|
|
2022
|
|
|
2021
|
|
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Product revenue, net
|
$
|
89,222
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|
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$
|
141,442
|
|
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$
|
277,004
|
|
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$
|
436,598
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|
|
Licensing and royalty revenue
|
|
656
|
|
|
|
596
|
|
|
|
1,944
|
|
|
|
2,098
|
|
|
Total revenue, net
|
|
89,878
|
|
|
|
142,038
|
|
|
|
278,948
|
|
|
|
438,696
|
|
|
Less: Cost of goods sold
|
|
23,941
|
|
|
|
30,211
|
|
|
|
81,990
|
|
|
|
90,692
|
|
|
Less: Cost of goods sold - restructuring inventory
|
|
3,078
|
|
|
|
—
|
|
|
|
18,078
|
|
|
|
—
|
|
|
Gross margin
|
|
62,859
|
|
|
|
111,827
|
|
|
|
178,880
|
|
|
|
348,004
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
58,745
|
|
|
|
102,965
|
|
|
|
236,285
|
|
|
|
315,966
|
|
|
Research and development
|
|
5,765
|
|
|
|
7,820
|
|
|
|
25,172
|
|
|
|
23,554
|
|
|
Restructuring
|
|
3,493
|
|
|
|
14,115
|
|
|
|
13,706
|
|
|
|
14,115
|
|
|
Total operating expenses
|
|
68,003
|
|
|
|
124,900
|
|
|
|
275,163
|
|
|
|
353,635
|
|
|
Operating loss
|
|
(5,144
|
)
|
|
|
(13,073
|
)
|
|
|
(96,283
|
)
|
|
|
(5,631
|
)
|
|
Interest income, net
|
|
750
|
|
|
|
163
|
|
|
|
1,241
|
|
|
|
919
|
|
|
Other income (expense), net
|
|
511
|
|
|
|
(57
|
)
|
|
|
(1,990
|
)
|
|
|
(390
|
)
|
|
Loss from operations before taxes
|
|
(3,883
|
)
|
|
|
(12,967
|
)
|
|
|
(97,032
|
)
|
|
|
(5,102
|
)
|
|
Income tax provision
|
|
(1,257
|
)
|
|
|
(184
|
)
|
|
|
(9,627
|
)
|
|
|
(1,867
|
)
|
|
Net loss
|
$
|
(5,140
|
)
|
|
$
|
(13,151
|
)
|
|
$
|
(106,659
|
)
|
|
$
|
(6,969
|
)
|
|
Loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
$
|
(0.01
|
)
|
|
$
|
(0.03
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(0.02
|
)
|
|
Diluted
|
$
|
(0.01
|
)
|
|
$
|
(0.03
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(0.02
|
)
|
|
Weighted average shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
404,614
|
|
|
|
396,618
|
|
|
|
399,944
|
|
|
|
395,681
|
|
|
Diluted
|
|
404,614
|
|
|
|
396,618
|
|
|
|
399,944
|
|
|
|
395,681
|
|
See notes to condensed consolidated financial
statements.
4
AMARIN CORPORATION PLC
CONDENSED CONSOLIDATED STATEMENT OF
CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited, in thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
Shares
|
|
|
Treasury
Shares
|
|
|
Common
Stock
|
|
|
Additional
Paid-in
Capital
|
|
|
Treasury
Stock
|
|
|
Accumulated
Deficit
|
|
|
Total
|
|
|
December 31, 2021
|
|
|
404,084,775
|
|
|
|
(7,486,767
|
)
|
|
$
|
294,027
|
|
|
$
|
1,855,246
|
|
|
$
|
(60,726
|
)
|
|
$
|
(1,421,448
|
)
|
|
$
|
667,099
|
|
|
Exercise of stock options
|
|
|
10,602
|
|
|
|
—
|
|
|
|
6
|
|
|
|
24
|
|
|
|
—
|
|
|
|
—
|
|
|
|
30
|
|
|
Vesting of restricted stock units
|
|
|
493,381
|
|
|
|
(161,083
|
)
|
|
|
331
|
|
|
|
(331
|
)
|
|
|
(535
|
)
|
|
|
—
|
|
|
|
(535
|
)
|
|
Stock-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
6,078
|
|
|
|
—
|
|
|
|
—
|
|
|
|
6,078
|
|
|
Loss for the period
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(31,563
|
)
|
|
|
(31,563
|
)
|
|
March 31, 2022
|
|
|
404,588,758
|
|
|
|
(7,647,850
|
)
|
|
$
|
294,364
|
|
|
$
|
1,861,017
|
|
|
$
|
(61,261
|
)
|
|
$
|
(1,453,011
|
)
|
|
$
|
641,109
|
|
|
Issuance of common stock under employee stock purchase
plan
|
|
|
265,214
|
|
|
|
—
|
|
|
|
166
|
|
|
|
217
|
|
|
|
—
|
|
|
|
—
|
|
|
|
383
|
|
|
Exercise of stock options
|
|
|
14,645
|
|
|
|
—
|
|
|
|
9
|
|
|
|
10
|
|
|
|
—
|
|
|
|
—
|
|
|
|
19
|
|
|
Vesting of restricted stock units
|
|
|
187,835
|
|
|
|
(61,551
|
)
|
|
|
120
|
|
|
|
(120
|
)
|
|
|
(158
|
)
|
|
|
—
|
|
|
|
(158
|
)
|
|
Stock-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
8,646
|
|
|
|
—
|
|
|
|
—
|
|
|
|
8,646
|
|
|
Loss for the period
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(69,956
|
)
|
|
|
(69,956
|
)
|
|
June 30, 2022
|
|
|
405,056,452
|
|
|
|
(7,709,401
|
)
|
|
$
|
294,659
|
|
|
$
|
1,869,770
|
|
|
$
|
(61,419
|
)
|
|
$
|
(1,522,967
|
)
|
|
$
|
580,043
|
|
|
Issuance of common stock for milestone payment
|
|
|
5,817,942
|
|
|
|
|
|
|
3,461
|
|
|
|
4,742
|
|
|
|
|
|
|
|
|
|
8,203
|
|
|
Exercise of stock options
|
|
|
8,056
|
|
|
|
—
|
|
|
|
5
|
|
|
|
5
|
|
|
|
—
|
|
|
|
—
|
|
|
|
10
|
|
|
Vesting of restricted stock units
|
|
|
777,590
|
|
|
|
(121,684
|
)
|
|
|
471
|
|
|
|
(471
|
)
|
|
|
(166
|
)
|
|
|
—
|
|
|
|
(166
|
)
|
|
Stock-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,877
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,877
|
|
|
Loss for the period
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(5,140
|
)
|
|
|
(5,140
|
)
|
|
September 30, 2022
|
|
|
411,660,040
|
|
|
|
(7,831,085
|
)
|
|
$
|
298,596
|
|
|
$
|
1,878,923
|
|
|
$
|
(61,585
|
)
|
|
$
|
(1,528,107
|
)
|
|
$
|
587,827
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
Shares
|
|
|
Treasury
Shares
|
|
|
Common
Stock
|
|
|
Additional
Paid-in
Capital
|
|
|
Treasury
Stock
|
|
|
Accumulated
Deficit
|
|
|
Total
|
|
|
December 31, 2020
|
|
|
398,425,000
|
|
|
|
(5,886,919
|
)
|
|
$
|
290,115
|
|
|
$
|
1,817,649
|
|
|
$
|
(51,082
|
)
|
|
$
|
(1,429,177
|
)
|
|
$
|
627,505
|
|
|
Exercise of stock options
|
|
|
783,320
|
|
|
|
—
|
|
|
|
536
|
|
|
|
1,523
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,059
|
|
|
Vesting of restricted stock units
|
|
|
2,447,405
|
|
|
|
(1,003,965
|
)
|
|
|
1,709
|
|
|
|
(1,709
|
)
|
|
|
(7,252
|
)
|
|
|
—
|
|
|
|
(7,252
|
)
|
|
Stock-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
13,925
|
|
|
|
—
|
|
|
|
—
|
|
|
|
13,925
|
|
|
Loss for the period
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(1,626
|
)
|
|
|
(1,626
|
)
|
|
March 31, 2021
|
|
|
401,655,725
|
|
|
|
(6,890,884
|
)
|
|
$
|
292,360
|
|
|
$
|
1,831,388
|
|
|
$
|
(58,334
|
)
|
|
$
|
(1,430,803
|
)
|
|
$
|
634,611
|
|
|
Issuance of common stock under employee stock purchase
plan
|
|
|
226,402
|
|
|
|
—
|
|
|
|
161
|
|
|
|
867
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,028
|
|
|
Exercise of stock options
|
|
|
27,139
|
|
|
|
—
|
|
|
|
19
|
|
|
|
56
|
|
|
|
—
|
|
|
|
—
|
|
|
|
75
|
|
|
Vesting of restricted stock units
|
|
|
346,010
|
|
|
|
(142,204
|
)
|
|
|
242
|
|
|
|
(242
|
)
|
|
|
(677
|
)
|
|
|
—
|
|
|
|
(677
|
)
|
|
Stock-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,479
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,479
|
|
|
Income for the period
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
7,808
|
|
|
|
7,808
|
|
|
June 30, 2021
|
|
|
402,255,276
|
|
|
|
(7,033,088
|
)
|
|
$
|
292,782
|
|
|
$
|
1,834,548
|
|
|
$
|
(59,011
|
)
|
|
$
|
(1,422,995
|
)
|
|
$
|
645,324
|
|
|
Exercise of stock options
|
|
|
184,462
|
|
|
|
—
|
|
|
|
128
|
|
|
|
353
|
|
|
|
—
|
|
|
|
—
|
|
|
|
481
|
|
|
Vesting of restricted stock units
|
|
|
332,491
|
|
|
|
(125,735
|
)
|
|
|
230
|
|
|
|
(230
|
)
|
|
|
(591
|
)
|
|
|
—
|
|
|
|
(591
|
)
|
|
Stock-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
10,432
|
|
|
|
—
|
|
|
|
—
|
|
|
|
10,432
|
|
|
Loss for the period
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(13,151
|
)
|
|
|
(13,151
|
)
|
|
September 30, 2021
|
|
|
402,772,229
|
|
|
|
(7,158,823
|
)
|
|
$
|
293,140
|
|
|
$
|
1,845,103
|
|
|
$
|
(59,602
|
)
|
|
$
|
(1,436,146
|
)
|
|
$
|
642,495
|
|
See notes to condensed consolidated financial
statements.
5
AMARIN CORPORATION PLC
CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS
(Unaudited, in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30,
|
|
|
|
|
2022
|
|
|
2021
|
|
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(106,659
|
)
|
|
$
|
(6,969
|
)
|
|
Adjustments to reconcile loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
426
|
|
|
|
443
|
|
|
Amortization of investments
|
|
|
757
|
|
|
|
1,564
|
|
|
Stock-based compensation
|
|
|
19,601
|
|
|
|
26,836
|
|
|
Amortization of intangible asset
|
|
|
1,909
|
|
|
|
1,633
|
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
40,274
|
|
|
|
5,213
|
|
|
Inventory
|
|
|
(59,640
|
)
|
|
|
(120,404
|
)
|
|
Prepaid and other current assets
|
|
|
(5,706
|
)
|
|
|
9,601
|
|
|
Other long-term assets
|
|
|
—
|
|
|
|
(24
|
)
|
|
Interest receivable
|
|
|
483
|
|
|
|
723
|
|
|
Deferred revenue
|
|
|
(1,012
|
)
|
|
|
(1,500
|
)
|
|
Accounts payable and other current liabilities
|
|
|
(74,672
|
)
|
|
|
45,582
|
|
|
Other long-term liabilities
|
|
|
2,595
|
|
|
|
(995
|
)
|
|
Net cash used in operating activities
|
|
|
(181,644
|
)
|
|
|
(38,297
|
)
|
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
Maturities of securities
|
|
|
240,614
|
|
|
|
312,150
|
|
|
Purchases of securities
|
|
|
(37,507
|
)
|
|
|
(233,067
|
)
|
|
Disposal of furniture, fixtures and equipment
|
|
|
—
|
|
|
|
4
|
|
|
Net cash provided by investing activities
|
|
|
203,107
|
|
|
|
79,087
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
Proceeds from the issuance of common stock, net of transaction
costs
|
|
|
383
|
|
|
|
1,028
|
|
|
Proceeds from exercise of stock options, net of transaction
costs
|
|
|
59
|
|
|
|
2,615
|
|
|
Taxes paid related to stock-based awards
|
|
|
(859
|
)
|
|
|
(8,520
|
)
|
|
Net cash used in financing activities
|
|
|
(417
|
)
|
|
|
(4,877
|
)
|
|
NET INCREASE IN CASH AND CASH EQUIVALENTS AND
RESTRICTED CASH
|
|
|
21,046
|
|
|
|
35,913
|
|
|
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF
PERIOD
|
|
|
223,372
|
|
|
|
190,879
|
|
|
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, END OF
PERIOD
|
|
$
|
244,418
|
|
|
$
|
226,792
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
Cash (paid) received during the year for:
|
|
|
|
|
|
|
|
Income taxes
|
|
$
|
(1,490
|
)
|
|
$
|
3,670
|
|
|
Supplemental disclosure of non-cash transactions:
|
|
|
|
|
|
|
|
Initial recognition of operating lease right-of-use
asset
|
|
$
|
1,148
|
|
|
$
|
—
|
|
|
Laxdale Milestone
|
|
$
|
—
|
|
|
$
|
12,000
|
|
See notes to condensed consolidated financial
statements.
6
AMARIN CORPORATION PLC
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
For purposes of this Quarterly Report on Form 10-Q, ordinary shares
may also be referred to as “common shares” or “common
stock.”
(1) Nature of Business and Basis of Presentation
Nature of Business
Amarin Corporation plc, or Amarin, or the Company, is a
pharmaceutical company focused on the commercialization and
development of therapeutics to improve cardiovascular, or CV,
health and reduce CV risk. Most of the Company’s historical revenue
and sales, marketing and administrative activities and costs have
been associated with commercial operations in the United States, or
U.S. The Company has launched commercial operations in certain
European countries, such as the United Kingdom, or the UK, and
continues pre-launch commercial activities throughout the rest of
Europe. The Company’s operations outside of the U.S. and Europe are
in early stages of development with reliance on third-party
commercial partners in select geographies, including China where
regulatory approval for the Company’s lead product is being
actively sought.
The Company’s lead product, VASCEPA®
(icosapent ethyl), was first approved by the U.S. Food and Drug
Administration, or U.S. FDA, in July 2012 for use as an adjunct to
diet to reduce triglyceride, or TG, levels in adult patients with
severe (>500
mg/dL) hypertriglyceridemia. In January 2013, the Company launched
1-gram size VASCEPA in the U.S. and in October 2016, introduced a
smaller 0.5-gram capsule size. On December 13, 2019, the U.S. FDA
approved another indication and label expansion for VASCEPA based
on the results of the Company’s long-term cardiovascular outcomes
trial, REDUCE-IT®,
or Reduction of Cardiovascular Events with EPA – Intervention
Trial. VASCEPA is approved by the U.S. FDA as an adjunct to
maximally tolerated statin therapy for reducing persistent
cardiovascular risk in select high risk patients.
On March 30, 2020, following conclusion of a trial in late January
2020, the U.S. District Court for the District of Nevada, or the
Nevada Court, issued a ruling in favor of two generic drug
companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and
Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their
affiliates, or, collectively, the Defendants, that declared as
invalid several of the Company's patents covering the first U.S.
FDA-approved use of its drug, for use to reduce severely high
triglyceride levels, which is known as the MARINE indication. The
Company sought appeals of the Nevada Court judgment up to the
United States Supreme Court, but the Company was unsuccessful. On
June 18, 2021, the Company was notified that its petition for writ
of certiorari to the United States Supreme Court was denied. As a
result, the following generic versions of VASCEPA have obtained
U.S. FDA approval with labeling consistent with the MARINE
indication of VASCEPA and have entered the U.S. market:
|
|
|
|
|
|
Company
|
|
FDA MARINE Indication Approval
|
|
Launch Date
|
|
Hikma Pharmaceuticals USA Inc.
|
|
May 2020
|
|
November 2020
|
|
Dr. Reddy’s Laboratories, Inc.
|
|
August 2020
|
|
June 2021
|
|
Teva Pharmaceuticals USA, Inc.
|
|
September 2020
|
|
September 2022
(1)
|
|
Apotex, Inc.
|
|
June 2021
|
|
January 2022
|
(1) - Teva's launch consisted only of a 0.5-gram
capsule.
On March 26, 2021, the European Commission, or EC, approved the
marketing authorization application for VAZKEPA, hereinafter along
with the U.S. brand name VASCEPA, collectively referred to as
VASCEPA, in the European Union, or EU, to reduce the risk of
cardiovascular events in high-risk, statin-treated adult patients
who have elevated triglycerides (>150
mg/dL) and either established cardiovascular disease or diabetes
and at least one additional cardiovascular risk event. On April 22,
2021, the Company announced that the Medicines and Healthcare
Products Regulatory Agency, or MHRA, approved VAZKEPA in England,
Scotland and Wales to reduce cardiovascular risk through MHRA’s new
‘reliance’ route. Collectively CHMP, EMA, EC and MHRA are referred
to herein as the European Regulatory Authorities.
In November 2020, the Company announced topline results from the
Phase 3 clinical trial of VASCEPA conducted by the Company’s
partner in China. On February 9, 2021, the Company announced that
regulatory review processes for approval of VASCEPA in Mainland
China and Hong Kong had commenced. The Chinese National Medical
Products Administration, or NMPA, has accepted for review the new
drug application for VASCEPA based on the results from the Phase 3
clinical trial and the results from the Company’s prior studies of
VASCEPA. On February 23, 2022, the Hong Kong Department of Health
concluded their evaluation and approved the use of VASCEPA under
the REDUCE-IT indication.
The Company currently has strategic collaborations to develop and
commercialize VASCEPA in select territories outside the United
States. Amarin is responsible for supplying VASCEPA to all markets
in which the product is sold, including the United States, the
United Kingdom and Sweden, as well as, in Canada, Lebanon and the
United Arab Emirates where the drug is promoted and sold via
collaboration with third-party companies that compensate Amarin for
such supply. Amarin is not responsible for providing any generic
company with drug product. The Company operates in
one
business segment.
7
Basis of Presentation
The condensed consolidated financial statements included herein
have been prepared by the Company in accordance with accounting
principles generally accepted in the United States, or GAAP, and
pursuant to the rules and regulations of the Securities and
Exchange Commission, or the SEC. Certain information in the
footnote disclosures of the financial statements has been condensed
or omitted where it substantially duplicates information provided
in the Company’s latest audited consolidated financial statements,
in accordance with the rules and regulations of the SEC. These
condensed consolidated financial statements should be read in
conjunction with the Company’s audited consolidated financial
statements and notes included in its Annual Report on Form 10-K for
the fiscal year ended December 31, 2021, or the Form 10-K, filed
with the SEC. The balance sheet amounts in this report were derived
from the Company’s audited consolidated financial statements
included in the Form 10-K.
The condensed consolidated financial statements reflect all
adjustments of a normal and recurring nature that, in the opinion
of management, are necessary to present fairly the Company’s
financial position, results of operations and cash flows for the
periods indicated. The preparation of the Company’s condensed
consolidated financial statements in conformity with GAAP requires
management to make estimates and assumptions that affect the
reported amounts of assets and liabilities, disclosure of
contingent assets and liabilities at the date of the financial
statements, and the reported amounts of revenues and expenses
during the reporting period. The results of operations for the
three and nine months ended September 30, 2022 and 2021 are not
necessarily indicative of the results for any future period.
Certain numbers presented throughout this document may not add
precisely to the totals provided due to rounding. Absolute and
percentage changes are calculated using the underlying amounts in
thousands. The condensed consolidated financial statements include
the accounts of the Company and its wholly-owned subsidiaries. All
intercompany accounts and transactions have been eliminated in
consolidation.
The accompanying condensed consolidated financial statements of the
Company and subsidiaries have been prepared on a basis which
assumes that the Company will continue as a going concern, which
contemplates the realization of assets and the satisfaction of
liabilities and commitments in the normal course of business, as
well as the ongoing global pandemic, COVID-19.
At September 30, 2022, the Company had Total assets of
$908.3
million, of which
$306.0
million consisted of cash and liquid short-term and long-term
investments. More specifically, the Company had Current assets
of
$686.5
million, including Cash and cash equivalents of
$240.5
million, Short-term investments of
$63.2
million, Accounts receivable, net, of
$123.4
million and Inventory of
$227.6
million. In addition, as of September 30, 2022, the Company had
Long-term investments of
$2.3
million and Long-term inventory of
$188.0
million. As of September 30, 2022,
the Company had
no
debt outstanding.
(2) Significant Accounting Policies
Revenue Recognition
In accordance with Accounting Standards Codification, or ASC, Topic
606,
Revenue from Contracts with Customers,
or Topic 606, the Company recognizes revenue when its customer
obtains control of promised goods or services, in an amount that
reflects the consideration which the entity expects to receive in
exchange for those goods or services. To determine revenue
recognition for arrangements that an entity determines are within
the scope of Topic 606, the entity performs the following five
steps: (i) identify the contract(s) with a customer; (ii) identify
the performance obligations in the contract; (iii) determine the
transaction price; (iv) allocate the transaction price to the
performance obligations in the contract; and (v) recognize revenue
when (or as) the entity satisfies a performance obligation. The
Company only applies the five-step model to contracts when it is
probable that the entity will collect the consideration it is
entitled to in exchange for the goods or services it transfers to
the customer. At contract inception, once the contract is
determined to be within the scope of Topic 606, the Company
assesses the goods or services promised within each contract and
determines those that are performance obligations and assesses
whether each promised good or service is distinct. The Company then
recognizes as revenue the amount of the transaction price that is
allocated to the respective performance obligation when (or as) the
performance obligation is satisfied. For a complete discussion of
accounting for net product revenue and licensing revenue, see Note
8—Revenue Recognition.
Cash and Cash Equivalents and Restricted Cash
Cash and cash equivalents consist of cash, deposits with banks and
short-term highly liquid money market instruments with original
maturities at the date of purchase of 90 days or less. Restricted
cash represents cash and cash equivalents pledged to guarantee
repayment of certain expenses which may be incurred for business
travel under corporate credit cards held by employees.
Accounts Receivable, net
Accounts receivable, net, comprised of trade receivables, are
generally due within
30 days
and
are stated at amounts due from customers. The Company recognizes an
allowance for losses on accounts receivable in an amount equal to
the estimated probable losses net of any recoveries. The allowance
is based primarily on assessment of specific identifiable customer
accounts considered at risk or uncollectible, as well as an
analysis of current receivables aging and expected future
write-offs. The expense associated with the allowance for doubtful
accounts is recognized as Selling, general, and administrative
expense. The Company has not historically
8
experienced
any significant credit losses. All customer accounts are actively
managed and no losses in excess of amounts reserved are currently
expected; however, the Company is monitoring the potential negative
impact of COVID-19 on the Company’s customers’ ability to meet
their financial obligations.
The following table summarizes the impact of accounts receivable
reserves on the gross trade accounts receivable balances as
of
September 30, 2022 and December 31, 2021:
|
|
|
|
|
|
|
|
|
|
In thousands
|
|
September 30, 2022
|
|
|
December 31, 2021
|
|
|
Gross trade accounts receivable
|
|
$
|
182,829
|
|
|
$
|
262,948
|
|
|
Trade allowances
|
|
|
(47,656
|
)
|
|
|
(86,636
|
)
|
|
Chargebacks
|
|
|
(10,849
|
)
|
|
|
(11,714
|
)
|
|
Allowance for doubtful accounts
|
|
|
(945
|
)
|
|
|
(945
|
)
|
|
Accounts receivable, net
|
|
$
|
123,379
|
|
|
$
|
163,653
|
|
Inventory
The Company states inventories at the lower of cost or net
realizable value. Cost is determined based on actual cost using the
average cost method. Net realizable value is the estimated selling
price in the ordinary course of business, less reasonably
predictable costs of completion, disposal, and transportation. The
Company classifies inventory as long-term inventory when
consumption of the inventory is expected beyond the operating
cycle. An allowance is established when management determines that
certain inventories may not be saleable. If inventory cost exceeds
expected net realizable value due to obsolescence, damage or
quantities in excess of expected demand, changes in price levels or
other causes, the Company will reduce the carrying value of such
inventory to net realizable value and recognize the difference as a
component of cost of goods sold in the period in which it occurs.
The Company capitalizes inventory purchases of saleable product
from approved suppliers while inventory purchases from suppliers
prior to regulatory approval are included as a component of
research and development expense. The Company expenses inventory
identified for use as marketing samples when they are packaged. The
average cost reflects the actual purchase price of VASCEPA active
pharmaceutical ingredient, or API.
Income Taxes
Deferred tax assets and liabilities are recognized for the future
tax consequences of differences between the carrying amounts and
tax bases of assets and liabilities and operating loss
carryforwards and other tax attributes using enacted rates expected
to be in effect when those differences reverse. Valuation
allowances are provided against deferred tax assets that are not
more likely than not to be realized. Deferred tax assets and
liabilities are classified as non-current in the condensed
consolidated balance sheet.
The Company provides reserves for potential payments of tax to
various tax authorities and does not recognize tax benefits related
to uncertain tax positions and other issues. Tax benefits for
uncertain tax positions are based on a determination of whether a
tax benefit taken by the Company in its tax filings or positions is
more likely than not to be realized, assuming that the matter in
question will be decided based on its technical merits. The
Company’s policy is to record interest and penalties in the
provision for income taxes, as applicable.
The Company regularly assesses its ability to realize deferred tax
assets. Changes in historical earnings performance, future earnings
projections, and changes in tax laws, among other factors, may
cause the Company to adjust its valuation allowance on deferred tax
assets, which would impact the Company’s income tax expense in the
period in which it is determined that these factors have
changed.
Excess tax benefits and deficiencies that arise upon vesting or
exercise of share-based payments are recognized as an income tax
benefit and expense, respectively, in the condensed consolidated
statement of operations. Excess income tax benefits are classified
as cash flows from operating activities and cash paid to taxing
authorities arising from the withholding of shares from employees
are classified as cash flows from financing activities.
The Company’s and its subsidiaries’ income tax returns are
periodically examined by various tax authorities, including the
Internal Revenue Service, or IRS, and states. The Company is
currently under audit by the IRS for the Company’s
2018
U.S. income tax return and by the New Jersey Department of Treasury
for the years
2012
to
2015.
Although the outcome of tax audits is always uncertain and could
result in significant cash tax payments, the Company does not
believe the outcome of these audits will have a material adverse
effect on its consolidated financial position or results of
operations.
Loss per Share
Basic net loss per share is determined by dividing net loss by the
weighted average shares of common stock outstanding during the
period. Diluted net loss per share is determined by dividing net
loss by diluted weighted average shares outstanding. Diluted
weighted average shares reflects the dilutive effect, if any, of
potentially dilutive common shares, such as from the exercise of
stock options and vesting of restricted stock units calculated
using the treasury stock method. In periods with reported net
operating losses, all stock options and restricted stock units
outstanding are deemed anti-dilutive such that basic and diluted
net loss per share are equal.
9
The calculation of net loss and the number of shares used to
compute basic and diluted net loss per share for the three
and
nine months ended September 30, 2022 and 2021 are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended September 30,
|