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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 June 30, 2021
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the transition period ________ to ________
Commission File Number 1-32302
ANTARES PHARMA, INC.
A Delaware Corporation
(State or Other Jurisdiction of Incorporation)
|
|
41-1350192
(I.R.S. Employer Identification No.)
|
100 Princeton South, Suite 300, Ewing, NJ
|
|
08628
|
(Address of Principal Executive Offices)
|
|
(Zip Code)
|
Registrant’s telephone number, including area code: (609)
359-3020
Securities registered pursuant to Section 12(b) of the
Act:
Title of each class
|
|
Trading
Symbol(s)
|
|
Name of each exchange on which registered
|
Common Stock, par value $0.01 per share
|
|
ATRS
|
|
NASDAQ
|
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.
Large accelerated filer
|
|
☐
|
|
Accelerated filer
|
|
☒
|
|
|
|
|
|
|
|
Non–accelerated filer
|
|
☐
|
|
Smaller reporting company
|
|
☐
|
|
|
|
|
|
|
|
Emerging growth company
|
|
☐
|
|
|
|
|
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 Exchange
Act). Yes ☐ No ☒
Indicate by check mark whether the registrant has filed all
documents and reports required to be filed by Sections 12, 13 or
15(d) of the Securities Exchange Act of 1934 subsequent to the
distribution of securities under a plan confirmed by a court.
Yes ☐ No ☐
As of August 1, 2021, the registrant had 169,967,638, shares of common stock, $0.01
par value per share, outstanding.
ANTARES PHARMA, INC.
INDEX
2
PART I – FINANCIAL
INFORMATION
Item 1.
|
FINANCIAL
STATEMENTS
|
ANTARES PHARMA, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)
(UNAUDITED)
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2021
|
|
|
2020
|
|
Assets
|
|
|
|
|
|
|
|
|
Current Assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
45,126
|
|
|
$
|
53,137
|
|
Accounts receivable
|
|
|
54,224
|
|
|
|
42,221
|
|
Inventories
|
|
|
18,644
|
|
|
|
18,216
|
|
Contract assets
|
|
|
5,725
|
|
|
|
8,140
|
|
Prepaid expenses and other current assets
|
|
|
4,244
|
|
|
|
4,877
|
|
Total current assets
|
|
|
127,963
|
|
|
|
126,591
|
|
Deferred tax assets, net
|
|
|
45,249
|
|
|
|
46,982
|
|
Property and equipment, net
|
|
|
25,590
|
|
|
|
24,020
|
|
Operating lease right-of-use assets
|
|
|
4,014
|
|
|
|
4,621
|
|
Intangibles, net
|
|
|
7,280
|
|
|
|
7,693
|
|
Other assets
|
|
|
2,523
|
|
|
|
2,624
|
|
Total Assets
|
|
$
|
212,619
|
|
|
$
|
212,531
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
|
|
Current Liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
15,797
|
|
|
$
|
16,194
|
|
Accrued expenses and other liabilities
|
|
|
29,655
|
|
|
|
25,635
|
|
Long-term debt, current portion
|
|
|
22,813
|
|
|
|
16,230
|
|
Operating lease liabilities, current portion
|
|
|
1,035
|
|
|
|
1,203
|
|
Deferred revenue
|
|
|
2,675
|
|
|
|
3,943
|
|
Total current liabilities
|
|
|
71,975
|
|
|
|
63,205
|
|
Long-term debt
|
|
|
3,338
|
|
|
|
24,669
|
|
Operating lease liabilities, long-term
|
|
|
4,552
|
|
|
|
4,816
|
|
Other long-term liabilities
|
|
|
726
|
|
|
|
726
|
|
Total liabilities
|
|
|
80,591
|
|
|
|
93,416
|
|
Stockholders’ Equity:
|
|
|
|
|
|
|
|
|
Preferred Stock: $0.01 par; 3,000 shares authorized, none
outstanding
|
|
|
—
|
|
|
|
—
|
|
Common Stock: $0.01 par; 300,000 shares authorized; 169,584 and
166,836 issued and outstanding at June 30,
2021 and
December 31, 2020, respectively
|
|
|
1,696
|
|
|
|
1,668
|
|
Additional paid-in capital
|
|
|
345,431
|
|
|
|
340,756
|
|
Accumulated deficit
|
|
|
(214,413
|
)
|
|
|
(222,626
|
)
|
Accumulated other comprehensive loss
|
|
|
(686
|
)
|
|
|
(683
|
)
|
|
|
|
132,028
|
|
|
|
119,115
|
|
Total Liabilities and Stockholders’ Equity
|
|
$
|
212,619
|
|
|
$
|
212,531
|
|
See accompanying notes to condensed consolidated financial
statements.
3
ANTARES PHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(UNAUDITED)
|
|
For the Three Months Ended
|
|
|
For the Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
27,904
|
|
|
$
|
24,665
|
|
|
$
|
57,039
|
|
|
$
|
51,762
|
|
Licensing and development revenue
|
|
|
7,167
|
|
|
|
2,687
|
|
|
|
12,151
|
|
|
|
4,442
|
|
Royalties
|
|
|
9,907
|
|
|
|
5,032
|
|
|
|
17,871
|
|
|
|
9,259
|
|
Total revenue
|
|
|
44,978
|
|
|
|
32,384
|
|
|
|
87,061
|
|
|
|
65,463
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales
|
|
|
11,630
|
|
|
|
10,927
|
|
|
|
24,128
|
|
|
|
24,941
|
|
Cost of development revenue
|
|
|
4,810
|
|
|
|
1,550
|
|
|
|
8,757
|
|
|
|
2,583
|
|
Research and development
|
|
|
4,047
|
|
|
|
2,417
|
|
|
|
6,687
|
|
|
|
5,398
|
|
Selling, general and administrative
|
|
|
17,704
|
|
|
|
14,448
|
|
|
|
35,311
|
|
|
|
30,870
|
|
Total operating expenses
|
|
|
38,191
|
|
|
|
29,342
|
|
|
|
74,883
|
|
|
|
63,792
|
|
Operating income
|
|
|
6,787
|
|
|
|
3,042
|
|
|
|
12,178
|
|
|
|
1,671
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
(1,135
|
)
|
|
|
(967
|
)
|
|
|
(2,097
|
)
|
|
|
(2,028
|
)
|
Other, net
|
|
|
(89
|
)
|
|
|
100
|
|
|
|
(135
|
)
|
|
|
176
|
|
Total other expense, net
|
|
|
(1,224
|
)
|
|
|
(867
|
)
|
|
|
(2,232
|
)
|
|
|
(1,852
|
)
|
Net income (loss) before income taxes
|
|
|
5,563
|
|
|
|
2,175
|
|
|
|
9,946
|
|
|
|
(181
|
)
|
Income tax expense
|
|
|
(1,143
|
)
|
|
|
—
|
|
|
|
(1,733
|
)
|
|
|
—
|
|
Net income (loss)
|
|
$
|
4,420
|
|
|
$
|
2,175
|
|
|
$
|
8,213
|
|
|
$
|
(181
|
)
|
Net income (loss) per common share, basic
|
|
$
|
0.03
|
|
|
$
|
0.01
|
|
|
$
|
0.05
|
|
|
$
|
(0.00
|
)
|
Net income (loss) per common share, diluted
|
|
$
|
0.03
|
|
|
$
|
0.01
|
|
|
$
|
0.05
|
|
|
$
|
(0.00
|
)
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
169,043
|
|
|
|
165,703
|
|
|
|
168,436
|
|
|
|
165,566
|
|
Diluted
|
|
|
174,813
|
|
|
|
169,228
|
|
|
|
174,851
|
|
|
|
165,566
|
|
See accompanying notes to condensed consolidated financial
statements.
4
ANTARES PHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(LOSS)
(in thousands)
(UNAUDITED)
|
|
For the Three Months Ended
|
|
|
For the Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Net income (loss)
|
|
$
|
4,420
|
|
|
$
|
2,175
|
|
|
$
|
8,213
|
|
|
$
|
(181
|
)
|
Foreign currency translation adjustment
|
|
|
7
|
|
|
|
4
|
|
|
|
(3
|
)
|
|
|
6
|
|
Comprehensive income (loss)
|
|
$
|
4,427
|
|
|
$
|
2,179
|
|
|
$
|
8,210
|
|
|
$
|
(175
|
)
|
See accompanying notes to condensed consolidated financial
statements.
5
ANTARES PHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
EQUITY
(in thousands)
(UNAUDITED)
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Additional
Paid-In
Capital
|
|
|
Accumulated
Deficit
|
|
|
Other
Comprehensive
Loss
|
|
|
Total
Stockholders’
Equity
|
|
March 31, 2021
|
|
|
168,798
|
|
|
$
|
1,688
|
|
|
$
|
344,063
|
|
|
$
|
(218,833
|
)
|
|
$
|
(693
|
)
|
|
$
|
126,225
|
|
Common stock issued under equity
compensation plan, net of
shares withheld for taxes
|
|
|
525
|
|
|
|
5
|
|
|
|
(1,228
|
)
|
|
|
|
|
|
|
|
|
|
|
(1,223
|
)
|
Exercise of options
|
|
|
261
|
|
|
|
3
|
|
|
|
535
|
|
|
|
—
|
|
|
|
—
|
|
|
|
538
|
|
Share-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
2,061
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,061
|
|
Net income
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,420
|
|
|
|
—
|
|
|
|
4,420
|
|
Other comprehensive income
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
7
|
|
|
|
7
|
|
June 30, 2021
|
|
|
169,584
|
|
|
$
|
1,696
|
|
|
$
|
345,431
|
|
|
$
|
(214,413
|
)
|
|
$
|
(686
|
)
|
|
$
|
132,028
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Additional
Paid-In
Capital
|
|
|
Accumulated
Deficit
|
|
|
Other
Comprehensive
Loss
|
|
|
Total
Stockholders’
Equity
|
|
December 31, 2020
|
|
|
166,836
|
|
|
$
|
1,668
|
|
|
$
|
340,756
|
|
|
$
|
(222,626
|
)
|
|
$
|
(683
|
)
|
|
$
|
119,115
|
|
Common stock issued under equity
compensation plan, net of
shares withheld for taxes
|
|
|
942
|
|
|
|
10
|
|
|
|
(2,851
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
(2,841
|
)
|
Exercise of options
|
|
|
1,806
|
|
|
|
18
|
|
|
|
3,860
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3,878
|
|
Share-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
3,666
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3,666
|
|
Net income
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
8,213
|
|
|
|
—
|
|
|
|
8,213
|
|
Other comprehensive loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(3
|
)
|
|
|
(3
|
)
|
June 30, 2021
|
|
|
169,584
|
|
|
$
|
1,696
|
|
|
$
|
345,431
|
|
|
$
|
(214,413
|
)
|
|
$
|
(686
|
)
|
|
$
|
132,028
|
|
See accompanying notes to condensed consolidated financial
statements.
6
ANTARES PHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
EQUITY
(in thousands)
(UNAUDITED)
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Additional
Paid-In
Capital
|
|
|
Accumulated
Deficit
|
|
|
Other
Comprehensive
Loss
|
|
|
Total
Stockholders’
Equity
|
|
March 31, 2020
|
|
|
165,560
|
|
|
$
|
1,656
|
|
|
$
|
334,025
|
|
|
$
|
(281,183
|
)
|
|
$
|
(700
|
)
|
|
$
|
53,798
|
|
Common stock issued under equity
compensation plan, net of
shares withheld for taxes
|
|
|
451
|
|
|
|
4
|
|
|
|
(757
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
(753
|
)
|
Exercise of options
|
|
|
74
|
|
|
|
1
|
|
|
|
117
|
|
|
|
—
|
|
|
|
—
|
|
|
|
118
|
|
Share-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
1,987
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,987
|
|
Net income
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,175
|
|
|
|
—
|
|
|
|
2,175
|
|
Other comprehensive loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4
|
|
|
|
4
|
|
June 30, 2020
|
|
|
166,085
|
|
|
$
|
1,661
|
|
|
$
|
335,372
|
|
|
$
|
(279,008
|
)
|
|
$
|
(696
|
)
|
|
$
|
57,329
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Additional
Paid-In
Capital
|
|
|
Accumulated
Deficit
|
|
|
Other
Comprehensive
Loss
|
|
|
Total
Stockholders’
Equity
|
|
December 31, 2019
|
|
|
165,221
|
|
|
$
|
1,652
|
|
|
$
|
332,377
|
|
|
$
|
(278,827
|
)
|
|
$
|
(702
|
)
|
|
|
54,500
|
|
Common stock issued under equity
compensation plan, net of
shares withheld for taxes
|
|
|
669
|
|
|
|
7
|
|
|
|
(1,357
|
)
|
|
|
—
|
|
|
|
—
|
|
|
|
(1,350
|
)
|
Exercise of options
|
|
|
195
|
|
|
|
2
|
|
|
|
387
|
|
|
|
—
|
|
|
|
—
|
|
|
|
389
|
|
Share-based compensation
|
|
|
—
|
|
|
|
—
|
|
|
|
3,965
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3,965
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(181
|
)
|
|
|
—
|
|
|
|
(181
|
)
|
Other comprehensive income
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
6
|
|
|
|
6
|
|
June 30, 2020
|
|
|
166,085
|
|
|
$
|
1,661
|
|
|
$
|
335,372
|
|
|
$
|
(279,008
|
)
|
|
$
|
(696
|
)
|
|
$
|
57,329
|
|
See accompanying notes to condensed consolidated financial
statements.
7
ANTARES PHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(UNAUDITED)
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
|
2021
|
|
|
2020
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
8,213
|
|
|
|
(181
|
)
|
Adjustments to reconcile net income (loss) to cash provided by
operating activities:
|
|
|
|
|
|
|
|
|
Stock-based compensation expense
|
|
|
3,666
|
|
|
|
3,965
|
|
Depreciation and amortization
|
|
|
1,815
|
|
|
|
1,132
|
|
Other
|
|
|
353
|
|
|
|
519
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(12,007
|
)
|
|
|
785
|
|
Inventories
|
|
|
(427
|
)
|
|
|
(3,605
|
)
|
Contract assets
|
|
|
2,415
|
|
|
|
1,222
|
|
Prepaid expenses and other assets
|
|
|
633
|
|
|
|
(106
|
)
|
Deferred taxes
|
|
|
1,733
|
|
|
|
—
|
|
Accounts payable
|
|
|
(960
|
)
|
|
|
3,680
|
|
Accrued expenses and other liabilities
|
|
|
4,242
|
|
|
|
1,247
|
|
Deferred revenue
|
|
|
(1,265
|
)
|
|
|
603
|
|
Net cash provided by operating activities
|
|
|
8,411
|
|
|
|
9,261
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(2,457
|
)
|
|
|
(2,444
|
)
|
Proceeds from maturities of investment securities
|
|
|
—
|
|
|
|
14,500
|
|
Net cash provided by (used in) investing activities
|
|
|
(2,457
|
)
|
|
|
12,056
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Principal payments on long-term debt
|
|
|
(15,000
|
)
|
|
|
—
|
|
Proceeds from exercise of stock options
|
|
|
3,878
|
|
|
|
389
|
|
Taxes paid related to net share settlement of equity awards
|
|
|
(2,841
|
)
|
|
|
(1,350
|
)
|
Net cash used in financing activities
|
|
|
(13,963
|
)
|
|
|
(961
|
)
|
Effect of exchange rate changes on cash
|
|
|
(2
|
)
|
|
|
1
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(8,011
|
)
|
|
|
20,357
|
|
Cash and cash equivalents:
|
|
|
|
|
|
|
|
|
Beginning of period
|
|
|
53,137
|
|
|
|
23,201
|
|
End of period
|
|
$
|
45,126
|
|
|
$
|
43,558
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
1,719
|
|
|
$
|
1,810
|
|
Supplemental disclosure of non-cash investing activities:
|
|
|
|
|
|
|
|
|
Purchases of property and equipment recorded in accounts
payable
and accrued expenses
|
|
$
|
2,534
|
|
|
$
|
3,334
|
|
See accompanying notes to condensed consolidated financial
statements.
8
ANTARES PHARMA, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(in thousands, except per share amounts)
1.
|
Description of Business
|
Antares Pharma, Inc. (“Antares,” “we,” “our,” “us” or the
“Company”) is a specialty pharmaceutical company focused primarily
on the development and commercialization of pharmaceutical products
and technologies in targeted therapeutic areas. We develop,
manufacture and commercialize, for ourselves or with partners,
novel therapeutic products using our advanced drug delivery systems
that are designed to provide commercial or functional advantages,
such as improved safety and efficacy, convenience, improved
tolerability, and enhanced patient comfort and adherence. We also
seek product opportunities that complement and leverage our
commercial platform. We have a portfolio of proprietary and
partnered commercial products and ongoing product development
programs in various stages of development. We have formed
significant strategic alliances and partnership arrangements with
industry leading pharmaceutical companies including Teva
Pharmaceutical Industries, Ltd. (“Teva”), AMAG Pharmaceuticals,
Inc. (“AMAG”), Pfizer Inc. (“Pfizer”) and Idorsia Pharmaceuticals
Ltd (“Idorsia”).
Our marketed proprietary products include:
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XYOSTED®
(testosterone enanthate) injection, indicated for testosterone
replacement therapy in adult males for conditions associated with a
deficiency or absence of endogenous testosterone, and is the first
and only subcutaneous testosterone enanthate product for
once-weekly, at-home self-administration to be approved by the U.S.
Food and Drug Administration (“FDA”);
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OTREXUP®
(methotrexate) injection, indicated for adults with severe active
rheumatoid arthritis, children with active polyarticular juvenile
idiopathic arthritis and adults with severe recalcitrant psoriasis;
and
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NOCDURNA®
(desmopressin acetate), marketed in the U.S. for the treatment of
nocturia due to nocturnal polyuria (NP) in adults who awaken at
least two times per night to urinate.
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The Company is also party to various partnered product development
and supply arrangements:
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We developed and are the exclusive
supplier of devices for Teva’s Epinephrine Injection USP products,
the generic equivalent of EpiPen® and
EpiPen® Jr.,
indicated for emergency treatment of severe allergic reactions
including those that are life threatening (anaphylaxis) in adults
and certain pediatric patients;
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Through our commercialization partner
Teva, we sell Sumatriptan Injection USP, a generic equivalent to
the Imitrex®
STATdose Pen®,
indicated in the U.S. for the acute treatment of migraine headaches
and cluster headache in adults;
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In collaboration with AMAG, we
developed a subcutaneous auto injector and are the exclusive
supplier of devices and the final assembled and packaged commercial
product of AMAG’s Makena®
(hydroxyprogesterone caproate injection) subcutaneous auto
injector, which is a ready-to-administer treatment indicated to
reduce the risk of preterm birth in women pregnant with one baby
and who spontaneously delivered at least one preterm baby in the
past; and
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