Delaware
|
001-38137
|
47-2608175
|
||
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(IRS Employer Identification No.)
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55 Cambridge Parkway
Suite 100
Cambridge, Massachusetts
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02142
|
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(Address of principal executive offices)
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(Zip Code)
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)
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Item 2.02 |
Results of Operations and Financial Condition.
|
Item 9.01. |
Financial Statements and Exhibits.
|
(d) |
Exhibits.
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99.1
|
Press Release dated August 6, 2018.
|
AKCEA THERAPEUTICS, INC.
|
|||
Date: August 6, 2018
|
By:
|
/s/ Paula Soteropoulos
|
|
Paula Soteropoulos
Chief Executive Officer
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|||
99.1 |
Press Release dated August 6, 2018.
|
· |
Launch of TEGSEDI in Europe, starting with Germany.
|
· |
Potential approval and launch of WAYLIVRA in the US, EU and Canada.
|
· |
Potential approval and launch of TEGSEDI in the US and Canada.
|
· |
Report top-line results in the second half of 2018 from a Phase 2 trial of AKCEA-APO(a)-LRx in patients with cardiovascular disease caused by elevated lipoprotein(a), or Lp(a).
|
· |
Initiate Phase 1 clinical studies of AKCEA-TTR-LRx.
|
· |
Approval of TEGSEDI in the European Union for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis, or hATTR.
|
· |
Vote in favor of supporting approval of WAYLIVRA for treatment of Familial Chylomicronemia Syndrome, or FCS, by the FDA Advisory Committee.
|
· |
Announcement and closing of the partnership with Ionis to commercialize the TTR franchise.
|
· |
Announcement and closing of the partnership with PTC Therapeutics to commercialize TEGSEDI and WAYLIVRA in Latin America.
|
· |
Results published from the pivotal study of TEGSEDI in the July 5th edition of the New England Journal of Medicine.
|
· |
Appointment of industry leader Dr. Richard Moscicki to Akcea’s Board of Directors.
|
· |
Launch of hATTR Compass, a genetic testing program for people with suspected hATTR amyloidosis.
|
· |
Completion of landmark RE-FOCUS study to assess disease burden in people living with FCS.
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
R&D Revenue
|
18,321
|
5,713
|
35,429
|
11,807
|
||||||||||||
Expenses:
|
||||||||||||||||
Research and development
|
39,457
|
18,487
|
67,427
|
83,282
|
||||||||||||
General and administrative
|
42,287
|
6,915
|
61,752
|
11,590
|
||||||||||||
Total operating expenses
|
81,744
|
25,402
|
129,179
|
94,872
|
||||||||||||
Loss from operations
|
(63,423
|
)
|
(19,689
|
)
|
(93,750
|
)
|
(83,065
|
)
|
||||||||
Other income (expense):
|
||||||||||||||||
Investment income
|
1,546
|
245
|
2,414
|
308
|
||||||||||||
Interest expense
|
-
|
(965
|
)
|
-
|
(1,507
|
)
|
||||||||||
Other income (expense)
|
45
|
50
|
(123
|
)
|
50
|
|||||||||||
Loss before income tax expense
|
(61,832
|
)
|
(20,359
|
)
|
(91,459
|
)
|
(84,214
|
)
|
||||||||
Income tax expense
|
(214
|
)
|
-
|
(214
|
)
|
-
|
||||||||||
Net loss
|
(62,046
|
)
|
(20,359
|
)
|
(91,673
|
)
|
(84,214
|
)
|
||||||||
Net loss per share of preferred stock, basic and diluted
|
-
|
(0.70
|
)
|
-
|
(2.92
|
)
|
||||||||||
Weighted-average shares of preferred stock outstanding, basic and diluted
|
-
|
28,884,540
|
-
|
28,884,540
|
||||||||||||
Net loss per share of common stock owned by Ionis, basic and diluted
|
(0.72
|
)
|
-
|
(1.19
|
)
|
-
|
||||||||||
Weighted-average shares of common stock outstanding owned by Ionis, basic and diluted
|
60,832,494
|
-
|
53,182,685
|
-
|
||||||||||||
Net loss per share of common stock owned by others, basic and diluted
|
(0.85
|
)
|
-
|
(1.33
|
)
|
-
|
||||||||||
Weighted-average shares of common stock outstanding owned by others, basic and diluted
|
21,492,157
|
-
|
21,332,650
|
-
|
Three months ended
June 30,
|
Six months ended
June 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
As reported operating expenses according to GAAP
|
81,744
|
25,402
|
129,179
|
94,872
|
||||||||||||
Excluding compensation expense related to equity awards
|
(12,126
|
)
|
(3,942
|
)
|
(18,509
|
)
|
(7,122
|
)
|
||||||||
Pro forma operating expenses
|
69,618
|
21,460
|
110,670
|
87,750
|
||||||||||||
As reported loss from operations according to GAAP
|
(63,423
|
)
|
(19,689
|
)
|
(93,750
|
)
|
(83,065
|
)
|
||||||||
Excluding compensation expense related to equity awards
|
(12,126
|
)
|
(3,942
|
)
|
(18,509
|
)
|
(7,122
|
)
|
||||||||
Pro forma loss from operations
|
(51,297
|
)
|
(15,747
|
)
|
(75,241
|
)
|
(75,943
|
)
|
||||||||
As reported net loss according to GAAP
|
(62,046
|
)
|
(20,359
|
)
|
(91,673
|
)
|
(84,214
|
)
|
||||||||
Excluding compensation expense related to equity awards
|
(12,126
|
)
|
(3,942
|
)
|
(18,509
|
)
|
(7,122
|
)
|
||||||||
Pro forma net loss
|
(49,920
|
)
|
(16,417
|
)
|
(73,164
|
)
|
(77,092
|
)
|
June 30,
2018
|
December 31,
2017
|
|||||||
(unaudited)
|
||||||||
Assets:
|
||||||||
Cash and cash equivalents
|
216,840
|
58,367
|
||||||
Short-term investments
|
165,011
|
201,763
|
||||||
Contract receivable
|
3,295
|
5,413
|
||||||
Other current assets
|
3,575
|
1,302
|
||||||
Property, plant and equipment, net
|
1,523
|
77
|
||||||
Licenses, net
|
1,714
|
1,221
|
||||||
Deposits and other assets
|
3,047
|
661
|
||||||
Total assets
|
395,005
|
268,804
|
||||||
Liabilities and stockholders' equity (deficit)
|
||||||||
Accounts payable
|
2,706
|
2,381
|
||||||
Payable to Ionis Pharmaceuticals, Inc.
|
27,137
|
14,365
|
||||||
Accrued compensation
|
4,548
|
4,083
|
||||||
Accrued liabilities
|
25,969
|
7,570
|
||||||
Current portion of deferred revenue
|
35,713
|
58,192
|
||||||
Other current liabilities
|
1,138
|
1,875
|
||||||
Long-term portion of deferred rent
|
1,551
|
12
|
||||||
Long-term portion of deferred revenue
|
5,839
|
12,501
|
||||||
Stockholders' equity
|
290,404
|
167,825
|
||||||
Total liabilities and stockholders' equity
|
395,005
|
268,804
|