|
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 SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
33-0336973
|
|
(State or other jurisdiction of
incorporation or organization) |
(IRS Employer Identification No.)
|
2855 Gazelle Court, Carlsbad, CA
|
92010
|
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
Title of each class
|
Name of each exchange on which registered
|
|
Common Stock, $.001 Par Value
|
The Nasdaq Stock Market, LLC
|
Large accelerated filer
|
Accelerated filer
|
Non-accelerated filer
|
Smaller reporting company
|
(Do not check if a smaller reporting company)
|
|
Emerging growth company
|
PART I
|
FINANCIAL INFORMATION
|
|
ITEM 1:
|
Financial Statements:
|
|
Condensed Consolidated Balance Sheets as of September 30, 2018 and December 31, 2017 (unaudited) (as revised)
|
3
|
|
Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2018 and 2017 (unaudited) (as revised)
|
4
|
|
Condensed Consolidated Statements of Comprehensive Income (Loss) for the three and nine months ended September 30, 2018 and 2017 (unaudited) (as revised)
|
5
|
|
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2018 and 2017 (unaudited) (as revised)
|
6
|
|
Notes to Condensed Consolidated Financial Statements (unaudited)
|
7
|
|
ITEM 2:
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations:
|
|
Overview
|
31
|
|
Results of Operations
|
40
|
|
Liquidity and Capital Resources
|
45
|
|
ITEM 3:
|
Quantitative and Qualitative Disclosures about Market Risk
|
47
|
ITEM 4:
|
Controls and Procedures
|
47
|
PART II
|
OTHER INFORMATION
|
48
|
ITEM 1:
|
Legal Proceedings
|
48
|
ITEM 1A:
|
Risk Factors
|
48
|
ITEM 2:
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
57
|
ITEM 3:
|
Default upon Senior Securities
|
57
|
ITEM 4:
|
Mine Safety Disclosures
|
57
|
ITEM 5:
|
Other Information
|
57
|
ITEM 6:
|
Exhibits
|
58
|
SIGNATURES
|
59
|
September 30,
2018
|
December 31,
2017
|
|||||||
(as revised*)
|
||||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
479,891
|
$
|
129,630
|
||||
Short-term investments
|
1,479,098
|
893,085
|
||||||
Contracts receivable
|
14,732
|
62,955
|
||||||
Inventories
|
8,378
|
9,982
|
||||||
Other current assets
|
97,125
|
73,082
|
||||||
Total current assets
|
2,079,224
|
1,168,734
|
||||||
Property, plant and equipment, net
|
132,003
|
121,907
|
||||||
Patents, net
|
24,027
|
22,004
|
||||||
Deposits and other assets
|
12,659
|
10,129
|
||||||
Total assets
|
$
|
2,247,913
|
$
|
1,322,774
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
13,576
|
$
|
24,886
|
||||
Accrued compensation
|
24,259
|
25,151
|
||||||
Accrued liabilities
|
50,786
|
66,618
|
||||||
Current portion of long-term obligations
|
14,472
|
1,621
|
||||||
Current portion of deferred contract revenue
|
157,145
|
125,336
|
||||||
Total current liabilities
|
260,238
|
243,612
|
||||||
Long-term deferred contract revenue
|
523,384
|
108,026
|
||||||
1 percent convertible senior notes
|
559,184
|
533,111
|
||||||
Long-term obligations, less current portion
|
5,138
|
12,974
|
||||||
Long-term mortgage debt
|
59,825
|
59,771
|
||||||
Total liabilities
|
1,407,769
|
957,494
|
||||||
Stockholders’ equity:
|
||||||||
Common stock, $0.001 par value; 300,000,000 shares authorized, 137,506,203 and 124,976,373 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively
|
138
|
125
|
||||||
Additional paid-in capital
|
2,030,313
|
1,553,681
|
||||||
Accumulated other comprehensive loss
|
(32,532
|
)
|
(31,759
|
)
|
||||
Accumulated deficit
|
(1,287,369
|
)
|
(1,241,034
|
)
|
||||
Total Ionis stockholders’ equity
|
710,550
|
281,013
|
||||||
Noncontrolling interest in Akcea Therapeutics, Inc.
|
129,594
|
84,267
|
||||||
Total stockholders’ equity
|
840,144
|
365,280
|
||||||
Total liabilities and stockholders’ equity
|
$
|
2,247,913
|
$
|
1,322,774
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
Revenue:
|
(as revised*)
|
(as revised*)
|
||||||||||||||
Commercial revenue:
|
||||||||||||||||
SPINRAZA royalties
|
$
|
70,010
|
$
|
32,890
|
$
|
167,743
|
$
|
60,467
|
||||||||
Licensing and other royalty revenue
|
12,746
|
1,727
|
14,232
|
5,639
|
||||||||||||
Total commercial revenue
|
82,756
|
34,617
|
181,975
|
66,106
|
||||||||||||
Research and development revenue under collaborative agreements
|
62,639
|
83,697
|
225,584
|
280,281
|
||||||||||||
Total revenue
|
145,395
|
118,314
|
407,559
|
346,387
|
||||||||||||
|
||||||||||||||||
Expenses:
|
||||||||||||||||
Research, development and patent
|
95,255
|
80,214
|
301,153
|
246,358
|
||||||||||||
Selling, general and administrative
|
68,712
|
26,788
|
178,563
|
62,782
|
||||||||||||
Total operating expenses
|
163,967
|
107,002
|
479,716
|
309,140
|
||||||||||||
|
||||||||||||||||
Income (loss) from operations
|
(18,572
|
)
|
11,312
|
(72,157
|
)
|
37,247
|
||||||||||
|
||||||||||||||||
Other income (expense):
|
||||||||||||||||
Investment income
|
9,963
|
2,811
|
18,711
|
7,504
|
||||||||||||
Interest expense
|
(11,282
|
)
|
(10,825
|
)
|
(33,332
|
)
|
(33,966
|
)
|
||||||||
Loss on extinguishment of financing liability for leased facility
|
—
|
(7,689
|
)
|
—
|
(7,689
|
)
|
||||||||||
Other income (expenses)
|
(22
|
)
|
(2,141
|
)
|
(145
|
)
|
(3,528
|
)
|
||||||||
|
||||||||||||||||
Loss before income tax expense
|
(19,913
|
)
|
(6,532
|
)
|
(86,923
|
)
|
(432
|
)
|
||||||||
|
||||||||||||||||
Income tax expense
|
(452
|
)
|
(961
|
)
|
(824
|
)
|
(1,184
|
)
|
||||||||
|
||||||||||||||||
Net loss
|
(20,365
|
)
|
(7,493
|
)
|
(87,747
|
)
|
(1,616
|
)
|
||||||||
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc.
|
15,806
|
4,882
|
41,412
|
4,882
|
||||||||||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders
|
$
|
(4,559
|
)
|
$
|
(2,611
|
)
|
$
|
(46,335
|
)
|
$
|
3,266
|
|||||
Basic net income (loss) per share
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
$
|
(0.33
|
)
|
$
|
0.13
|
|||||
Shares used in computing basic net income (loss) per share
|
143,314
|
124,370
|
132,518
|
123,746
|
||||||||||||
Diluted net income (loss) per share
|
$
|
(0.03
|
)
|
$
|
(0.02
|
)
|
$
|
(0.33
|
)
|
$
|
0.13
|
|||||
Shares used in computing diluted net income (loss) per share
|
143,314
|
124,370
|
132,518
|
125,858
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
(as revised*)
|
(as revised*)
|
|||||||||||||||
Net loss
|
$
|
(20,365
|
)
|
$
|
(7,493
|
)
|
$
|
(87,747
|
)
|
$
|
(1,616
|
)
|
||||
Unrealized gains (losses) on debt securities, net of tax
|
133
|
215
|
(834
|
)
|
610
|
|||||||||||
Reclassification adjustment for realized gains included in net income (loss)
|
—
|
—
|
—
|
(374
|
)
|
|||||||||||
Currency translation adjustment
|
(28
|
)
|
(42
|
)
|
61
|
(77
|
)
|
|||||||||
|
||||||||||||||||
Comprehensive loss
|
(20,260
|
)
|
(7,320
|
)
|
(88,520
|
)
|
(1,457
|
)
|
||||||||
Comprehensive loss attributable to noncontrolling interests
|
15,797
|
3,952
|
41,455
|
3,952
|
||||||||||||
Comprehensive income (loss) attributable to Ionis Pharmaceuticals, Inc. stockholders
|
$
|
(4,463
|
)
|
$
|
(3,368
|
)
|
$
|
(47,065
|
)
|
$
|
2,495
|
Nine Months Ended
September 30,
|
||||||||
2018
|
2017
|
|||||||
Operating activities:
|
(as revised*)
|
|||||||
Net loss
|
$
|
(87,747
|
)
|
$
|
(1,616
|
)
|
||
Adjustments to reconcile net loss to net cash provided by operating activities:
|
||||||||
Depreciation
|
7,650
|
6,138
|
||||||
Amortization of patents
|
1,356
|
1,216
|
||||||
Amortization of premium on investments, net
|
791
|
5,227
|
||||||
Amortization of debt issuance costs
|
1,343
|
1,202
|
||||||
Amortization of convertible senior notes discount
|
24,781
|
22,963
|
||||||
Amortization of long-term financing liability for leased facility
|
—
|
3,659
|
||||||
Stock-based compensation expense
|
97,210
|
63,642
|
||||||
Gain on investment in Regulus Therapeutics, Inc.
|
—
|
(374
|
)
|
|||||
Loss on extinguishment of financing liability for leased facility
|
—
|
7,689
|
||||||
Non-cash losses related to patents, licensing and property, plant and equipment
|
482
|
(403
|
)
|
|||||
Changes in operating assets and liabilities:
|
||||||||
Contracts receivable
|
48,223
|
65,119
|
||||||
Inventories
|
1,604
|
(962
|
)
|
|||||
Other current and long-term assets
|
(26,573
|
)
|
(34,866
|
)
|
||||
Accounts payable
|
(13,606
|
)
|
(1,707
|
)
|
||||
Accrued compensation
|
(892
|
)
|
(8,999
|
)
|
||||
Accrued liabilities and deferred rent
|
(14,392
|
)
|
(5,251
|
)
|
||||
Deferred contract revenue
|
447,168
|
31,071
|
||||||
Net cash provided by operating activities
|
487,398
|
153,748
|
||||||
Investing activities:
|
||||||||
Purchases of short-term investments
|
(1,156,335
|
)
|
(589,655
|
)
|
||||
Proceeds from the sale of short-term investments
|
568,517
|
313,860
|
||||||
Purchases of property, plant and equipment
|
(12,221
|
)
|
(26,502
|
)
|
||||
Acquisition of licenses and other assets, net
|
(3,317
|
)
|
(4,289
|
)
|
||||
Proceeds from the sale of Regulus Therapeutics stock
|
—
|
2,507
|
||||||
Net cash used in investing activities
|
(603,356
|
)
|
(304,079
|
)
|
||||
Financing activities:
|
||||||||
Proceeds from equity awards
|
18,254
|
17,672
|
||||||
Proceeds from the issuance of common stock from Akcea Therapeutics, Inc.’s initial public offering, net of underwriters’ discount
|
—
|
110,438
|
||||||
Proceeds from building mortgage debt, net of issuance costs
|
—
|
59,750
|
||||||
Proceeds from the issuance of common stock to Novartis
|
—
|
71,737
|
||||||
Proceeds from the issuance of common stock to Biogen
|
447,965
|
—
|
||||||
Offering costs paid
|
—
|
(1,057
|
)
|
|||||
Proceeds from the sale of Akcea Therapeutics, Inc. common stock to Novartis in a private placement
|
—
|
50,000
|
||||||
Payment to settle financing liability for leased facility
|
—
|
(80,133
|
)
|
|||||
Principal payments on debt and capital lease obligations
|
—
|
(3,577
|
)
|
|||||
Net cash provided by financing activities
|
466,219
|
224,830
|
||||||
Net increase in cash and cash equivalents
|
350,261
|
74,499
|
||||||
Cash and cash equivalents at beginning of period
|
129,630
|
84,685
|
||||||
Cash and cash equivalents at end of period
|
$
|
479,891
|
$
|
159,184
|
||||
Supplemental disclosures of cash flow information:
|
||||||||
Interest paid
|
$
|
5,434
|
$
|
4,020
|
||||
Supplemental disclosures of non-cash investing and financing activities:
|
||||||||
Amounts accrued for capital and patent expenditures
|
$
|
2,296
|
$
|
3,475
|
||||
Purchases of property, plant and equipment included in long-term obligations
|
$
|
3,596
|
$
|
—
|
||||
Unpaid deferred offering costs
|
$
|
—
|
$
|
638
|
At December 31, 2017
|
||||||||||||
As Previously
Reported under
Topic 605
|
Topic 606
Adjustment
|
As Revised
|
||||||||||
Current portion of deferred revenue
|
$
|
106,465
|
$
|
18,871
|
$
|
125,336
|
||||||
Long-term portion of deferred revenue
|
$
|
72,708
|
$
|
35,318
|
$
|
108,026
|
||||||
Accumulated deficit
|
$
|
(1,187,398
|
)
|
$
|
(53,636
|
)
|
$
|
(1,241,034
|
)
|
|||
Noncontrolling interest in Akcea Therapeutics, Inc.
|
$
|
87,847
|
$
|
(3,580
|
)
|
$
|
84,267
|
|||||
Total stockholders’ equity
|
$
|
418,719
|
$
|
(53,439
|
)
|
$
|
365,280
|
Three Months Ended September 30, 2017
|
||||||||||||
As Previously
Reported under
Topic 605
|
Topic 606
Adjustment
|
As Revised
|
||||||||||
Revenue:
|
||||||||||||
Commercial revenue:
|
||||||||||||
SPINRAZA royalties
|
$
|
32,890
|
$
|
—
|
$
|
32,890
|
||||||
Licensing and other royalty revenue
|
879
|
848
|
1,727
|
|||||||||
Total commercial revenue
|
33,769
|
848
|
34,617
|
|||||||||
Research and development revenue under collaborative agreements
|
87,142
|
(3,445
|
)
|
83,697
|
||||||||
Total revenue
|
$
|
120,911
|
$
|
(2,597
|
)
|
$
|
118,314
|
|||||
Income (loss) from operations
|
$
|
13,909
|
$
|
(2,597
|
)
|
$
|
11,312
|
|||||
Net income (loss)
|
$
|
(4,896
|
)
|
$
|
(2,597
|
)
|
$
|
(7,493
|
)
|
|||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders
|
$
|
(976
|
)
|
$
|
(1,635
|
)
|
$
|
(2,611
|
)
|
|||
Net income (loss) per share, basic and diluted
|
$
|
0.00
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
Nine Months Ended September 30, 2017
|
||||||||||||
As Previously
Reported under
Topic 605
|
Topic 606
Adjustment
|
As Revised
|
||||||||||
Revenue:
|
||||||||||||
Commercial revenue:
|
||||||||||||
SPINRAZA royalties
|
$
|
60,467
|
$
|
—
|
$
|
60,467
|
||||||
Licensing and other royalty revenue
|
4,983
|
656
|
5,639
|
|||||||||
Total commercial revenue
|
65,450
|
656
|
66,106
|
|||||||||
Research and development revenue under collaborative agreements
|
269,917
|
10,364
|
280,281
|
|||||||||
Total revenue
|
$
|
335,367
|
$
|
11,020
|
$
|
346,387
|
||||||
Income from operations
|
$
|
26,227
|
$
|
11,020
|
$
|
37,247
|
||||||
Net income (loss)
|
$
|
(12,636
|
)
|
$
|
11,020
|
$
|
(1,616
|
)
|
||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders
|
$
|
(8,716
|
)
|
$
|
11,982
|
$
|
3,266
|
|||||
Net income (loss) per share, basic
|
$
|
0.02
|
$
|
0.11
|
$
|
0.13
|
||||||
Net income (loss) per share, diluted
|
$
|
0.02
|
$
|
0.11
|
$
|
0.13
|
Nine Months Ended September 30, 2017
|
||||||||||||
As Previously
Reported under
Topic 605
|
Topic 606
Adjustment
|
As Revised
|
||||||||||
Net income (loss)
|
$
|
(12,636
|
)
|
$
|
11,020
|
$
|
(1,616
|
)
|
||||
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
||||||||||||
Deferred contract revenue
|
$
|
42,091
|
$
|
(11,020
|
)
|
$
|
31,071
|
|||||
Cash and cash equivalents at beginning of period
|
$
|
84,685
|
$
|
—
|
$
|
84,685
|
||||||
Cash and cash equivalents at end of period
|
$
|
159,184
|
$
|
—
|
$
|
159,184
|
● |
A change in how we recognize milestone payments: Topic 606 requires us to amortize more of the milestone payments we achieve, rather than recognizing the milestone payments in full in the period in which we achieved the milestone event as we did under Topic 605. This change resulted in an increase of $0.5 million and $27.9 million for the three and nine months ended September 30, 2017, respectively.
|
● |
A change in how we calculate revenue for payments we are recognizing into revenue over time: Under Topic 605, we amortized payments into revenue evenly over the period of our obligations. When we made a change to our estimated completion period, we recognized that change on a prospective basis. Under Topic 606, we are required to use an input method to determine the amount we amortize each reporting period. Each period, we review our “inputs” such as our level of effort expended, including the time we estimate it will take us to complete the activities, or costs incurred relative to the total expected inputs to satisfy the performance obligation. For certain collaborations, such as Bayer, Janssen and Novartis, the input method resulted in a change to the revenue we had previously recognized using a straight-line amortization method. This change resulted in a decrease of $4.0 million and $17.5 million for the three and nine months ended September 30, 2017, respectively.
|
1. |
Identify the contract
|
● |
We and our partner approved the contract and we are both committed to perform our obligations;
|
● |
We have identified our rights, our partner’s rights and the payment terms;
|
● |
We have concluded that the contract has commercial substance, meaning that the risk, timing, or amount of our future cash flows is expected to change as a result of the contract; and
|
● |
We believe collectability is probable.
|
2. |
Identify the performance obligations
|
3. |
Determine the transaction price
|
4. |
Allocate the transaction price
|
● |
Estimated future product sales;
|
● |
Estimated royalties on future product sales;
|
● |
Contractual milestone payments;
|
● |
Expenses we expect to incur;
|
● |
Income taxes; and
|
● |
A discount rate.
|
● |
The number of internal hours we estimate we will spend performing these services;
|
● |
The estimated cost of work we will perform;
|
● |
The estimated cost of work that we will contract with third parties to perform; and
|
● |
The estimated cost of API we will use.
|
5. |
Recognize revenue
|
1) |
If the additional goods and/or services are distinct from the other performance obligations in the original agreement; and
|
2) |
If the goods and/or services are at a stand-alone selling price.
|
● |
Whether the agreements were negotiated together with a single objective;
|
● |
Whether the amount of consideration in one contract depends on the price or performance of the other agreement; or
|
● |
Whether the goods and/or services promised under the agreements are a single performance obligation.
|
At December 31, 2017
|
||||||||||||
As Previously
Reported under
Topic 605
|
Topic 606
Adjustment
|
As Revised
|
||||||||||
Current portion of deferred revenue
|
$
|
106,465
|
$
|
18,871
|
$
|
125,336
|
||||||
Long-term portion of deferred revenue
|
72,708
|
35,318
|
108,026
|
|||||||||
Total deferred revenue
|
$
|
179,173
|
$
|
54,189
|
$
|
233,362
|
● |
$24.2 million from Biogen;
|
● |
$15.9 million from AstraZeneca;
|
● |
$11.8 from Novartis; and
|
● |
$2.3 million from other partners.
|
Three months ended September 30, 2018
|
Weighted
Average Shares
Owned in Akcea
|
Akcea’s
Net Income (Loss)
Per Share
|
Ionis’ Portion of
Akcea’s Net Loss
|
|||||||||
Common shares
|
65,538
|
$
|
(0.73
|
)
|
$
|
(47,843
|
)
|
|||||
Akcea’s net loss attributable to our ownership
|
$
|
(47,843
|
)
|
|||||||||
Ionis’ stand-alone net income
|
43,226
|
|||||||||||
Net loss available to Ionis common stockholders
|
$
|
(4,616
|
)
|
|||||||||
Weighted average shares outstanding
|
143,314
|
|||||||||||
Basic net loss per share
|
$
|
(0.03
|
)
|
Nine months ended September 30, 2018
|
Weighted
Average Shares
Owned in Akcea
|
Akcea’s
Net Loss
Per Share
|
Ionis’ Portion of
Akcea’s Net Loss
|
|||||||||
Common shares
|
57,347
|
$
|
(1.93
|
)
|
$
|
(110,680
|
)
|
|||||
Akcea’s net loss attributable to our ownership
|
$
|
(110,680
|
)
|
|||||||||
Ionis’ stand-alone net income
|
67,517
|
|||||||||||
Net income available to Ionis common stockholders
|
$
|
(43,162
|
)
|
|||||||||
Weighted average shares outstanding
|
132,518
|
|||||||||||
Basic net loss per share
|
$
|
(0.33
|
)
|
Three months ended September 30, 2017
|
Weighted
Average Shares
Owned in Akcea
|
Akcea’s
Net Loss
Per Share
|
Ionis’ Portion of
Akcea’s Net Loss
|
|||||||||
Common shares
|
36,556
|
$
|
(0.33
|
)
|
$
|
(12,063
|
)
|
|||||
Preferred shares
|
5,651
|
(0.01
|
)
|
(57
|
)
|
|||||||
Akcea’s net loss attributable to our ownership
|
$
|
(12,120
|
)
|
|||||||||
Ionis’ stand-alone net income
|
10,144
|
|||||||||||
Net loss available to Ionis common stockholders
|
$
|
(1,976
|
)
|
|||||||||
Weighted average shares outstanding
|
124,370
|
|||||||||||
Basic net income per share
|
$
|
(0.02
|
)
|
Nine months ended September 30, 2017
|
Weighted
Average Shares
Owned in Akcea
|
Akcea’s
Net Loss
Per Share
|
Ionis’ Portion of
Akcea’s Net Loss
|
|||||||||
Common shares
|
12,319
|
$
|
(3.12
|
)
|
$
|
(38,435
|
)
|
|||||
Preferred shares
|
21,055
|
(2.16
|
)
|
(45,479
|
)
|
|||||||
Akcea’s net loss attributable to our ownership
|
$
|
(83,914
|
)
|
|||||||||
Ionis’ stand-alone net income
|
100,235
|
|||||||||||
Net income available to Ionis common stockholders
|
$
|
16,321
|
||||||||||
Weighted average shares outstanding
|
123,746
|
|||||||||||
Basic net income per share
|
$
|
0.13
|
● |
1 percent convertible senior notes;
|
● |
2¾ percent convertible senior notes;
|
● |
Dilutive stock options;
|
● |
Unvested restricted stock units; and
|
● |
Employee Stock Purchase Plan, or ESPP.
|
Nine months ended September 30, 2017
|
Income
(Numerator)
|
Shares
(Denominator)
|
Per-Share
Amount
|
|||||||||
Net income available to Ionis common stockholders
|
$
|
16,321
|
123,746
|
$
|
0.13
|
|||||||
Effect of dilutive securities:
|
||||||||||||
Shares issuable upon exercise of stock options
|
—
|
1,658
|
||||||||||
Shares issuable upon restricted stock award issuance
|
—
|
430
|
||||||||||
Shares issuable related to our ESPP
|
—
|
24
|
||||||||||
Income available to Ionis common stockholders, plus assumed conversions
|
$
|
16,321
|
125,858
|
$
|
0.13
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
Beginning balance accumulated other comprehensive loss
|
$
|
(32,637
|
)
|
$
|
(30,372
|
)
|
$
|
(31,759
|
)
|
$
|
(30,358
|
)
|
||||
Unrealized gains (losses) on securities (1)
|
133
|
215
|
(834
|
)
|
610
|
|||||||||||
Amounts reclassified from accumulated other comprehensive loss
|
—
|
—
|
—
|
(374
|
)
|
|||||||||||
Currency translation adjustment
|
(28
|
)
|
(42
|
)
|
61
|
(77
|
)
|
|||||||||
Net current period other comprehensive income (loss)
|
105
|
173
|
(773
|
)
|
159
|
|||||||||||
Ending balance accumulated other comprehensive loss
|
$
|
(32,532
|
)
|
$
|
(30,199
|
)
|
$
|
(32,532
|
)
|
$
|
(30,199
|
)
|
(1) |
There was no income tax expense or benefit related to elements of other comprehensive income (loss) for the three and nine months ended September 30, 2018 and 2017.
|
Nine Months Ended
September 30,
|
|||||
2018
|
2017
|
||||
Risk-free interest rate
|
2.3%
|
1.8%
|
|||
Dividend yield
|
0.0%
|
0.0%
|
|||
Volatility
|
63.1%
|
66.1%
|
|||
Expected life
|
4.6 years
|
4.5 years
|
Nine Months Ended
September 30,
|
|||||
2018
|
2017
|
||||
Risk-free interest rate
|
2.8 %
|
2.2 %
|
|||
Dividend yield
|
0.0 %
|
0.0 %
|
|||
Volatility
|
61.5 %
|
61.2 %
|
|||
Expected life
|
6.6 years
|
6.6 years
|
Nine Months Ended
September 30,
|
|||||
2018
|
2017
|
||||
Risk-free interest rate
|
1.8%
|
0.8%
|
|||
Dividend yield
|
0.0%
|
0.0%
|
|||
Volatility
|
47.3%
|
59.9%
|
|||
Expected life
|
6 months
|
6 months
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Research, development and patent
|
$
|
18,780
|
$
|
16,181
|
$
|
57,698
|
$
|
48,443
|
||||||||
Selling, general and administrative
|
16,103
|
5,291
|
39,512
|
15,199
|
||||||||||||
Total non-cash stock-based compensation expense
|
$
|
34,883
|
$
|
21,472
|
$
|
97,210
|
$
|
63,642
|
One year or less
|
80%
|
After one year but within two years
|
15%
|
After two years but within three years
|
5%
|
Total
|
100%
|
Gross Unrealized
|
||||||||||||||||
September 30, 2018
|
Cost (1)
|
Gains
|
Losses
|
Estimated Fair Value
|
||||||||||||
Available-for-sale securities:
|
||||||||||||||||
Corporate debt securities (2)
|
$
|
841,397
|
$
|
23
|
$
|
(1,264
|
)
|
$
|
840,156
|
|||||||
Debt securities issued by U.S. government agencies
|
143,008
|
2
|
(169
|
)
|
142,841
|
|||||||||||
Debt securities issued by the U.S. Treasury (2)
|
154,280
|
—
|
(89
|
)
|
154,191
|
|||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states (2)
|
49,873
|
—
|
(330
|
)
|
49,543
|
|||||||||||
Total securities with a maturity of one year or less
|
1,188,558
|
25
|
(1,852
|
)
|
1,186,731
|
|||||||||||
Corporate debt securities
|
240,208
|
16
|
(1,420
|
)
|
238,804
|
|||||||||||
Debt securities issued by U.S. government agencies
|
32,435
|
—
|
(109
|
)
|
32,326
|
|||||||||||
Debt securities issued by the U.S. Treasury
|
9,872
|
—
|
(10
|
)
|
9,862
|
|||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states
|
31,666
|
—
|
(551
|
)
|
31,115
|
|||||||||||
Total securities with a maturity of more than one year
|
314,181
|
16
|
(2,090
|
)
|
312,107
|
|||||||||||
Total available-for-sale securities
|
$
|
1,502,739
|
$
|
41
|
$
|
(3,942
|
)
|
$
|
1,498,838
|
Gross Unrealized
|
||||||||||||||||
December 31, 2017
|
Cost (1)
|
Gains
|
Losses
|
Estimated Fair Value
|
||||||||||||
Available-for-sale securities:
|
||||||||||||||||
Corporate debt securities
|
$
|
500,599
|
$
|
2
|
$
|
(752
|
)
|
$
|
499,849
|
|||||||
Debt securities issued by U.S. government agencies
|
83,926
|
—
|
(212
|
)
|
83,714
|
|||||||||||
Debt securities issued by the U.S. Treasury
|
29,428
|
—
|
(17
|
)
|
29,411
|
|||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states (2)
|
29,240
|
4
|
(122
|
)
|
29,122
|
|||||||||||
Total securities with a maturity of one year or less
|
643,193
|
6
|
(1,103
|
)
|
642,096
|
|||||||||||
Corporate debt securities
|
148,663
|
8
|
(1,059
|
)
|
147,612
|
|||||||||||
Debt securities issued by U.S. government agencies
|
52,779
|
—
|
(168
|
)
|
52,611
|
|||||||||||
Debt securities issued by the U.S. Treasury
|
1,409
|
—
|
(2
|
)
|
1,407
|
|||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states
|
65,550
|
—
|
(740
|
)
|
64,810
|
|||||||||||
Total securities with a maturity of more than one year
|
268,401
|
8
|
(1,969
|
)
|
266,440
|
|||||||||||
Total available-for-sale securities
|
$
|
911,594
|
$
|
14
|
$
|
(3,072
|
)
|
$
|
908,536
|
(1) |
Our available-for-sale securities are held at amortized cost.
|
(2) |
Includes investments classified as cash equivalents on our condensed consolidated balance sheet.
|
Less than 12 Months of
Temporary Impairment
|
More than 12 Months of
Temporary Impairment
|
Total Temporary
Impairment
|
||||||||||||||||||||||||||
(In thousands)
|
Number of
Investments
|
Estimated
Fair Value
|
Unrealized
Losses
|
Estimated
Fair Value
|
Unrealized
Losses
|
Estimated
Fair Value
|
Unrealized
Losses
|
|||||||||||||||||||||
Corporate debt securities
|
495
|
$
|
889,172
|
$
|
(1,687
|
)
|
$
|
83,706
|
$
|
(997
|
)
|
$
|
972,878
|
$
|
(2,684
|
)
|
||||||||||||
Debt securities issued by U.S. government agencies
|
51
|
132,231
|
(139
|
)
|
26,862
|
(139
|
)
|
159,093
|
(278
|
)
|
||||||||||||||||||
Debt securities issued by the U.S. Treasury
|
32
|
164,053
|
(99
|
)
|
—
|
—
|
164,053
|
(99
|
)
|
|||||||||||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states
|
48
|
25,687
|
(191
|
)
|
51,747
|
(690
|
)
|
77,434
|
(881
|
)
|
||||||||||||||||||
Total temporarily impaired securities
|
626
|
$
|
1,211,143
|
$
|
(2,116
|
)
|
$
|
162,315
|
$
|
(1,826
|
)
|
$
|
1,373,458
|
$
|
(3,942
|
)
|
At
September 30, 2018
|
Quoted Prices in
Active Markets
(Level 1)
|
Significant Other
Observable Inputs
(Level 2)
|
||||||||||
Cash equivalents (1)
|
$
|
395,649
|
$
|
395,649
|
$
|
—
|
||||||
Corporate debt securities (2)
|
1,078,960
|
—
|
1,078,960
|
|||||||||
Debt securities issued by U.S. government agencies (3)
|
175,167
|
—
|
175,167
|
|||||||||
Debt securities issued by the U.S. Treasury (3)
|
164,053
|
164,053
|
—
|
|||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states (3)
|
80,658
|
—
|
80,658
|
|||||||||
Total
|
$
|
1,894,487
|
$
|
559,702
|
$
|
1,334,785
|
At
December 31, 2017
|
Quoted Prices in
Active Markets
(Level 1)
|
Significant Other
Observable Inputs
(Level 2)
|
||||||||||
Cash equivalents (1)
|
$
|
86,262
|
$
|
86,262
|
$
|
—
|
||||||
Corporate debt securities (3)
|
647,461
|
—
|
647,461
|
|||||||||
Debt securities issued by U.S. government agencies (3)
|
136,325
|
—
|
136,325
|
|||||||||
Debt securities issued by the U.S. Treasury (3)
|
30,818
|
30,818
|
—
|
|||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states (4)
|
93,932
|
—
|
93,932
|
|||||||||
Total
|
$
|
994,798
|
$
|
117,080
|
$
|
877,718
|
(1) |
Included in cash and cash equivalents on our condensed consolidated balance sheet.
|
(2) |
At September 30, 2018, $19.7 million was included in cash and cash equivalents on our condensed consolidated balance sheet, with the difference included in short-term investments on our condensed consolidated balance sheet.
|
(3) |
Included in short-term investments on our condensed consolidated balance sheet.
|
(4) |
At December 31, 2017, $3.5 million was included in cash and cash equivalents on our condensed consolidated balance sheet, with the difference included in short-term investments on our condensed consolidated balance sheet.
|
Beginning balance of Level 3 instruments at January 1, 2017
|
$
|
—
|
||
Value of the potential premium we would have received from Novartis at inception of the SPA (January 2017)
|
5,035
|
|||
Recurring fair value adjustment during the nine months ended September 30, 2017
|
(5,035
|
)
|
||
Ending balance of Level 3 instruments at September 30, 2017
|
$
|
—
|
(i)
|
a floating rate equal to the one-month London Interbank Offered Rate, or LIBOR, in effect plus 1.25 percent per annum;
|
(ii)
|
a fixed rate equal to LIBOR plus 1.25 percent for a period of one, two, three, four, six, or twelve months as elected by us; or
|
(iii)
|
a fixed rate equal to the LIBOR swap rate during the period of the loan.
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
SPINRAZA royalties (commercial revenue)
|
$
|
70.0
|
$
|
32.9
|
$
|
167.7
|
$
|
60.5
|
||||||||
R&D revenue
|
34.8
|
54.9
|
66.9
|
137.1
|
||||||||||||
Total revenue from our relationship with Biogen
|
104.8
|
87.8
|
234.6
|
197.6
|
||||||||||||
Percentage of total revenue
|
72
|
%
|
74
|
%
|
58
|
%
|
57
|
%
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
R&D revenue
|
$
|
14.2
|
$
|
4.8
|
$
|
86.5
|
$
|
14.8
|
||||||||
Percentage of total revenue
|
10
|
%
|
4
|
%
|
21
|
%
|
4
|
%
|
● |
We recognized $91.2 million for the exclusive license of IONIS-FXIRx in May 2015 because Bayer had full use of the license without any continuing involvement from us.
|
● |
We recognized $4.3 million for the R&D services for IONIS-FXIRx over the period of our performance, which ended in November 2016.
|
● |
We allocated $4.5 million for API, which we are recognizing into revenue as we deliver the API.
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
R&D revenue
|
$
|
1.9
|
$
|
0.4
|
$
|
3.3
|
$
|
66.0
|
||||||||
Percentage of total revenue
|
1
|
%
|
0
|
%
|
1
|
%
|
19
|
%
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
R&D revenue
|
$
|
0.9
|
$
|
3.4
|
$
|
6.6
|
$
|
18.1
|
||||||||
Percentage of total revenue
|
1
|
%
|
3
|
%
|
2
|
%
|
5
|
%
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
R&D revenue
|
$
|
1.8
|
$
|
4.5
|
$
|
5.4
|
$
|
5.9
|
||||||||
Percentage of total revenue
|
1
|
%
|
4
|
%
|
1
|
%
|
2
|
%
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
R&D revenue
|
$
|
0.1
|
$
|
4.6
|
$
|
1.5
|
$
|
14.4
|
||||||||
Percentage of total revenue
|
0
|
%
|
4
|
%
|
0
|
%
|
4
|
%
|
● |
R&D services for AKCEA-APO(a)-LRx;
|
● |
R&D services for AKCEA-APOCIII-LRx;
|
● |
API for AKCEA-APO(a)-LRx; and
|
● |
API for AKCEA-APOCIII-LRx.
|
● |
$75 million from the upfront payment;
|
● |
$28.4 million for the premium paid by Novartis for its purchase of our common stock at a premium in the first quarter of 2017; and
|
● |
$5.0 million for the potential premium Novartis would have paid if they purchased our common stock in the future.
|
● |
$64.0 million for the R&D services for AKCEA-APO(a)-LRx;
|
● |
$40.1 million for the R&D services for AKCEA-APOCIII-LRx;
|
● |
$1.5 million for the delivery of AKCEA-APO(a)-LRx API; and
|
● |
$2.8 million for the delivery of AKCEA-APOCIII-LRx API.
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
R&D revenue
|
$
|
7.2
|
$
|
9.9
|
$
|
42.7
|
$
|
21.7
|
||||||||
Percentage of total revenue
|
5
|
%
|
8
|
%
|
10
|
%
|
6
|
%
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
R&D revenue
|
$
|
12.0
|
$
|
0.0
|
$
|
12.0
|
$
|
0.0
|
||||||||
Percentage of total revenue
|
8
|
%
|
—
|
3
|
%
|
—
|
Three Months Ended September 30, 2018
|
Ionis Core
|
Akcea Therapeutics
|
Elimination of
Intercompany Activity
|
Total
|
||||||||||||
Revenue:
|
||||||||||||||||
Commercial revenue:
|
||||||||||||||||
SPINRAZA royalties
|
$
|
70,010
|
$
|
—
|
$
|
—
|
$
|
70,010
|
||||||||
Licensing and other royalty revenue
|
7,946
|
12,000
|
(7,200
|
)
|
12,746
|
|||||||||||
Total commercial revenue
|
77,956
|
12,000
|
(7,200
|
)
|
82,756
|
|||||||||||
R&D revenue under collaborative agreements
|
100,105
|
7,241
|
(44,707
|
)
|
62,639
|
|||||||||||
Total segment revenue
|
$
|
178,061
|
$
|
19,241
|
$
|
(51,907
|
)
|
$
|
145,395
|
|||||||
Total operating expenses
|
$
|
87,664
|
$
|
84,249
|
$
|
(7,946
|
)
|
$
|
163,967
|
|||||||
Income (loss) from operations
|
$
|
90,397
|
$
|
(65,008
|
)
|
$
|
(43,961
|
)
|
$
|
(18,572
|
)
|
Three Months Ended September 30, 2017 (as revised)
|
Ionis Core
|
Akcea Therapeutics
|
Elimination of
Intercompany Activity
|
Total
|
||||||||||||
Revenue:
|
||||||||||||||||
Commercial revenue:
|
||||||||||||||||
SPINRAZA royalties
|
$
|
32,890
|
$
|
—
|
$
|
—
|
$
|
32,890
|
||||||||
Licensing and other royalty revenue
|
1,727
|
—
|
—
|
1,727
|
||||||||||||
Total commercial revenue
|
34,617
|
—
|
—
|
34,617
|
||||||||||||
R&D revenue under collaborative agreements
|
73,791
|
9,906
|
—
|
83,697
|
||||||||||||
Total segment revenue
|
$
|
108,408
|
$
|
9,906
|
$
|
—
|
$
|
118,314
|
||||||||
Total operating expenses
|
$
|
81,019
|
$
|
26,013
|
$
|
(30
|
)
|
$
|
107,002
|
|||||||
Income (loss) from operations
|
$
|
27,389
|
$
|
(16,107
|
)
|
$
|
30
|
$
|
11,312
|
Nine Months Ended September 30, 2018
|
Ionis Core
|
Akcea Therapeutics
|
Elimination of
Intercompany Activity
|
Total
|
||||||||||||
Revenue:
|
||||||||||||||||
Commercial revenue:
|
||||||||||||||||
SPINRAZA royalties
|
$
|
167,743
|
$
|
—
|
$
|
—
|
$
|
167,743
|
||||||||
Licensing and other royalty revenue
|
9,432
|
12,000
|
(7,200
|
)
|
14,232
|
|||||||||||
Total commercial revenue
|
177,175
|
12,000
|
(7,200
|
)
|
181,975
|
|||||||||||
R&D revenue under collaborative agreements
|
232,850
|
42,670
|
(49,936
|
)
|
225,584
|
|||||||||||
Total segment revenue
|
$
|
410,025
|
$
|
54,670
|
$
|
(57,136
|
)
|
$
|
407,559
|
|||||||
Total operating expenses
|
$
|
279,084
|
$
|
213,428
|
$
|
(12,796
|
)
|
$
|
479,716
|
|||||||
Income (loss) from operations
|
$
|
130,941
|
$
|
(158,758
|
)
|
$
|
(44,340
|
)
|
$
|
(72,157
|
)
|
Nine Months Ended September 30, 2017 (as revised)
|
Ionis Core
|
Akcea Therapeutics
|
Elimination of
Intercompany Activity
|
Total
|
||||||||||||
Revenue:
|
||||||||||||||||
Commercial revenue:
|
||||||||||||||||
SPINRAZA royalties
|
$
|
60,467
|
$
|
—
|
$
|
—
|
$
|
60,467
|
||||||||
Licensing and other royalty revenue
|
5,639
|
—
|
—
|
5,639
|
||||||||||||
Total commercial revenue
|
66,106
|
—
|
—
|
66,106
|
||||||||||||
R&D revenue under collaborative agreements
|
312,976
|
21,712
|
(54,407
|
)
|
280,281
|
|||||||||||
Total segment revenue
|
$
|
379,082
|
$
|
21,712
|
$
|
(54,407
|
)
|
$
|
346,387
|
|||||||
Total operating expenses
|
$
|
242,753
|
$
|
120,884
|
$
|
(54,497
|
)
|
$
|
309,140
|
|||||||
Income (loss) from operations
|
$
|
136,329
|
$
|
(99,172
|
)
|
$
|
90
|
$
|
37,247
|
Total Assets
|
Ionis Core
|
Akcea Therapeutics
|
Elimination of
Intercompany Activity
|
Total
|
||||||||||||
September 30, 2018
|
$
|
2,446,425
|
$
|
379,128
|
$
|
(577,641
|
)
|
$
|
2,247,913
|
|||||||
December 31, 2017 (as revised)
|
$
|
1,342,578
|
$
|
268,804
|
$
|
(288,608
|
)
|
$
|
1,322,774
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||
(as revised)
|
(as revised)
|
||||||||||
Partner A
|
|
72%
|
|
|
74%
|
|
|
58%
|
|
|
57%
|
Partner B
|
|
10%
|
|
|
4%
|
|
|
21%
|
|
|
4%
|
Partner C
|
|
5%
|
|
|
8%
|
|
|
10%
|
|
|
6%
|
Partner D
|
8%
|
0%
|
3%
|
0%
|
|||||||
Partner E
|
1%
|
0%
|
1%
|
19%
|
ITEM 2 |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Total revenue
|
$
|
145,395
|
$
|
118,314
|
$
|
407,559
|
$
|
346,387
|
||||||||
Total operating expenses
|
$
|
163,967
|
$
|
107,002
|
$
|
479,716
|
$
|
309,140
|
||||||||
Income (loss) from operations
|
$
|
(18,572
|
)
|
$
|
11,312
|
$
|
(72,157
|
)
|
$
|
37,247
|
||||||
Net loss
|
$
|
(20,365
|
)
|
$
|
(7,493
|
)
|
$
|
(87,747
|
)
|
$
|
(1,616
|
)
|
||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders
|
$
|
(4,559
|
)
|
$
|
(2,611
|
)
|
$
|
(46,335
|
)
|
$
|
3,266
|
|
SPINRAZA – the first and only approved treatment for people with spinal muscular atrophy
|
o |
SPINRAZA sales continued to grow in the third quarter, both in the U.S. and ex-U.S., with global sales of more than $1 billion for year-to-date 2018, as reported by Biogen
|
o |
Nearly 6,000 SMA patients were on SPINRAZA as of the third quarter
|
o |
In the U.S., the number of adult patients on therapy grew by over 20 percent compared to the second quarter. Adult SMA patients, which represent the largest and most undertreated patient segment, accounted for more than 50 percent of start forms in the third quarter
|
o |
Access outside the U.S. expanded with formal reimbursement in 28 markets and continued revenue growth in the EU, Asia Pacific and Latin America
|
|
TEGSEDI (inotersen) – launched in multiple markets for the treatment of polyneuropathy of hATTR in adult patients
|
o |
TEGSEDI approved in the U.S., EU and Canada
|
o |
Commercial patients in Germany on TEGSEDI
|
o |
TEGSEDI prescriptions received in the U.S.
|
|
WAYLIVRA (volanesorsen) – under regulatory review for the treatment of people living with FCS
|
o |
Preparing for launch in the EU following approval
|
o |
Planning to confirm a path forward in the U.S. and Canada
|
|
We and Akcea reported positive top-line data from a Phase 2 study of AKCEA-APO(a)-LRx in people with high levels of Lp(a) and established cardiovascular disease demonstrating robust target reductions and a favorable safety and tolerability profile
|
|
We and Roche entered a new collaboration to develop IONIS-FB-LRx for the treatment of people with complement-mediated diseases. We received a $75 million upfront payment and will be eligible for development, regulatory and sales milestone payments and license fees of up to $684 million plus royalties of up to 20 percent on commercial sales
|
|
Positive Phase 1b/2 data for danvatirsen, in combination with durvalumab was presented at the European Society for Medical Oncology, or ESMO, 2018 Congress, demonstrating a response rate approximately double that of durvalumab alone, based on previous studies in patients with refractory head and neck cancer. We earned a $17.5 million milestone payment because AstraZeneca is advancing the program
|
|
We completed enrollment in a Phase 2b study of IONIS-FXIRx in patients with end-stage renal disease on dialysis, with data planned for mid-2019
|
|
We or our partners initiated clinical studies with IONIS-GHR-LRx (Phase 2), IONIS-C9Rx (Phase 1/2), IONIS-FXI-LRx and IONIS-AZ4-2.5-LRx (Phase 1)
|
|
We earned a $10 million milestone payment from AstraZeneca for advancing an undisclosed oncology program into development
|
|
We appointed Dr. Michael Hayden and Mr. Peter N. Reikes to our Board of Directors
|
|
Assessing the propriety of revenue recognition and associated deferred revenue;
|
|
Determining the proper valuation of investments in marketable securities;
|
|
Determining the appropriate cost estimates for unbilled preclinical studies and clinical development activities;
|
|
Estimating the impact of the Tax Act and our net deferred income tax asset valuation allowance;
|
|
Determining the fair value of convertible debt without the conversion feature; and
|
|
Valuing premiums received under our collaborations
|
|
Assessing the propriety of revenue recognition and associated deferred revenue.
|
At December 31, 2017
|
||||||||||||
As Previously
Reported under
Topic 605
|
Topic 606
Adjustment
|
As Revised
|
||||||||||
Current portion of deferred revenue
|
$
|
106,465
|
$
|
18,871
|
$
|
125,336
|
||||||
Long-term portion of deferred revenue
|
$
|
72,708
|
$
|
35,318
|
$
|
108,026
|
||||||
Accumulated deficit
|
$
|
(1,187,398
|
)
|
$
|
(53,636
|
)
|
$
|
(1,241,034
|
)
|
|||
Noncontrolling interest in Akcea Therapeutics, Inc.
|
$
|
87,847
|
$
|
(3,580
|
)
|
$
|
84,267
|
|||||
Total stockholders’ equity
|
$
|
418,719
|
$
|
(53,439
|
)
|
$
|
365,280
|
Three Months Ended September 30, 2017
|
||||||||||||
As Previously
Reported under
Topic 605
|
Topic 606
Adjustment
|
As Revised
|
||||||||||
Revenue:
|
||||||||||||
Commercial revenue:
|
||||||||||||
SPINRAZA royalties
|
$
|
32,890
|
$
|
—
|
$
|
32,890
|
||||||
Licensing and other royalty revenue
|
879
|
848
|
1,727
|
|||||||||
Total commercial revenue
|
33,769
|
848
|
34,617
|
|||||||||
Research and development revenue under collaborative agreements
|
87,142
|
(3,445
|
)
|
83,697
|
||||||||
Total revenue
|
$
|
120,911
|
$
|
(2,597
|
)
|
$
|
118,314
|
|||||
Income (loss) from operations
|
$
|
13,909
|
$
|
(2,597
|
)
|
$
|
11,312
|
|||||
Net income (loss)
|
$
|
(4,896
|
)
|
$
|
(2,597
|
)
|
$
|
(7,493
|
)
|
|||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders
|
$
|
(976
|
)
|
$
|
(1,635
|
)
|
$
|
(2,611
|
)
|
|||
Net income (loss) per share, basic and diluted
|
$
|
0.00
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
Nine Months Ended September 30, 2017
|
||||||||||||
As Previously
Reported under
Topic 605
|
Topic 606
Adjustment
|
As Revised
|
||||||||||
Revenue:
|
||||||||||||
Commercial revenue:
|
||||||||||||
SPINRAZA royalties
|
$
|
60,467
|
$
|
—
|
$
|
60,467
|
||||||
Licensing and other royalty revenue
|
4,983
|
656
|
5,639
|
|||||||||
Total commercial revenue
|
65,450
|
656
|
66,106
|
|||||||||
Research and development revenue under collaborative agreements
|
269,917
|
10,364
|
280,281
|
|||||||||
Total revenue
|
$
|
335,367
|
$
|
11,020
|
$
|
346,387
|
||||||
Income from operations
|
$
|
26,227
|
$
|
11,020
|
$
|
37,247
|
||||||
Net income (loss)
|
$
|
(12,636
|
)
|
$
|
11,020
|
$
|
(1,616
|
)
|
||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders
|
$
|
(8,716
|
)
|
$
|
11,982
|
$
|
3,266
|
|||||
Net income (loss) per share, basic
|
$
|
0.02
|
$
|
0.11
|
$
|
0.13
|
||||||
Net income (loss) per share, diluted
|
$
|
0.02
|
$
|
0.11
|
$
|
0.13
|
Nine Months Ended September 30, 2017
|
||||||||||||
As Previously
Reported under
Topic 605
|
Topic 606
Adjustment
|
As Revised
|
||||||||||
Net income (loss)
|
$
|
(12,636
|
)
|
$
|
11,020
|
$
|
(1,616
|
)
|
||||
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
||||||||||||
Deferred contract revenue
|
$
|
42,091
|
$
|
(11,020
|
)
|
$
|
31,071
|
|||||
Cash and cash equivalents at beginning of period
|
$
|
84,685
|
$
|
—
|
$
|
84,685
|
||||||
Cash and cash equivalents at end of period
|
$
|
159,184
|
$
|
—
|
$
|
159,184
|
● |
A change in how we recognize milestone payments: Topic 606 requires us to amortize more of the milestone payments we achieve, rather than recognizing the milestone payments in full in the period in which we achieved the milestone event as we did under Topic 605. This change resulted in an increase of $0.5 million and $27.9 million for the three and nine months ended September 30, 2017, respectively.
|
● |
A change in how we calculate revenue for payments we are recognizing into revenue over time: Under Topic 605, we amortized payments into revenue evenly over the period of our obligations. When we made a change to our estimated completion period, we recognized that change on a prospective basis. Under Topic 606, we are required to use an input method to determine the amount we amortize each reporting period. Each period, we review our “inputs” such as our level of effort expended, including the time we estimate it will take us to complete the activities, or costs incurred relative to the total expected inputs to satisfy the performance obligation. For certain collaborations, such as Bayer, Janssen and Novartis, the input method resulted in a change to the revenue we had previously recognized using a straight-line amortization method. This change resulted in a decrease of $4.0 million and $17.5 million for the three and nine months ended September 30, 2017, respectively.
|
1. |
Identify the contract
|
● |
We and our partner approved the contract and we are both committed to perform our obligations;
|
● |
We have identified our rights, our partner’s rights and the payment terms;
|
● |
We have concluded that the contract has commercial substance, meaning that the risk, timing, or amount of our future cash flows is expected to change as a result of the contract; and
|
● |
We believe collectability is probable.
|
2. |
Identify the performance obligations
|
3. |
Determine the transaction price
|
4. |
Allocate the transaction price
|
● |
Estimated future product sales;
|
● |
Estimated royalties on future product sales;
|
● |
Contractual milestone payments;
|
● |
Expenses we expect to incur;
|
● |
Income taxes; and
|
● |
A discount rate.
|
● |
The number of internal hours we estimate we will spend performing these services;
|
● |
The estimated cost of work we will perform;
|
● |
The estimated cost of work that we will contract with third parties to perform; and
|
● |
The estimated cost of API we will use.
|
5. |
Recognize revenue
|
1) |
If the additional goods and/or services are distinct from the other performance obligations in the original agreement; and
|
2) |
If the goods and/or services are at a stand-alone selling price.
|
● |
Whether the agreements were negotiated together with a single objective;
|
● |
Whether the amount of consideration in one contract depends on the price or performance of the other agreement; or
|
● |
Whether the goods and/or services promised under the agreements are a single performance obligation.
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2018
|
2017
|
2018
|
2017
|
||||||||||||
Revenue:
|
(as revised)
|
(as revised)
|
||||||||||||||
Commercial revenue:
|
||||||||||||||||
SPINRAZA royalties
|
$
|
70,010
|
$
|
32,890
|
$
|
167,743
|
$
|
60,467
|
||||||||
Licensing and other royalty revenue
|
12,746
|
1,727
|
14,232
|
5,639
|
||||||||||||
Total commercial revenue
|
82,756
|
34,617
|
181,975
|
66,106
|
||||||||||||
R&D revenue:
|
||||||||||||||||
Amortization from upfront payments
|
31,066
|
22,892
|
92,185
|
70,145
|
||||||||||||
Milestone payments
|
26,194
|
56,409
|
44,583
|
135,129
|
||||||||||||
License fees
|
1,649
|
424
|
64,227
|
64,942
|
||||||||||||
Other services
|
3,730
|
3,972
|
24,589
|
10,065
|
||||||||||||
Total R&D revenue
|
62,639
|
83,697
|
225,584
|
280,281
|
||||||||||||
Total revenue
|
$
|
145,395
|
$
|
118,314
|
$
|
407,559
|
$
|
346,387
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Ionis Core
|
$
|
65,512
|
$
|
64,239
|
$
|
213,114
|
$
|
190,924
|
||||||||
Akcea Therapeutics
|
71,518
|
21,321
|
182,188
|
109,071
|
||||||||||||
Elimination of intercompany activity
|
(7,946
|
)
|
(30
|
)
|
(12,796
|
)
|
(54,497
|
)
|
||||||||
Subtotal
|
129,084
|
85,530
|
382,506
|
245,498
|
||||||||||||
Non-cash compensation expense related to equity awards
|
34,883
|
21,472
|
97,210
|
63,642
|
||||||||||||
Total operating expenses
|
$
|
163,967
|
$
|
107,002
|
$
|
479,716
|
$
|
309,140
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Research, development and patent expenses
|
$
|
76,475
|
$
|
64,033
|
$
|
243,455
|
$
|
197,915
|
||||||||
Non-cash compensation expense related to equity awards
|
18,780
|
16,181
|
57,698
|
48,443
|
||||||||||||
Total research, development and patent expenses
|
$
|
95,255
|
$
|
80,214
|
$
|
301,153
|
$
|
246,358
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Ionis Core
|
$
|
49,452
|
$
|
48,776
|
$
|
158,860
|
$
|
157,363
|
||||||||
Akcea Therapeutics
|
27,068
|
15,287
|
89,940
|
95,049
|
||||||||||||
Elimination of intercompany activity
|
(45
|
)
|
(30
|
)
|
(5,345
|
)
|
(54,497
|
)
|
||||||||
Subtotal
|
76,475
|
64,033
|
243,455
|
197,915
|
||||||||||||
Non-cash compensation expense related to equity awards
|
18,780
|
16,181
|
57,698
|
48,443
|
||||||||||||
Total research, development and patent expenses
|
$
|
95,255
|
$
|
80,214
|
$
|
301,153
|
$
|
246,358
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Antisense drug discovery expenses, excluding non-cash compensation expense related to equity awards
|
$
|
14,475
|
$
|
14,071
|
$
|
41,970
|
$
|
39,831
|
||||||||
Non-cash compensation expense related to equity awards
|
4,379
|
3,935
|
13,204
|
11,644
|
||||||||||||
Total antisense drug discovery expenses
|
$
|
18,854
|
$
|
18,006
|
$
|
55,174
|
$
|
51,475
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
SPINRAZA
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
10,561
|
||||||||
WAYLIVRA
|
3,469
|
4,401
|
15,919
|
14,603
|
||||||||||||
TEGSEDI
|
3,373
|
4,230
|
14,404
|
16,340
|
||||||||||||
Other antisense development projects
|
21,413
|
11,183
|
62,580
|
32,852
|
||||||||||||
Development overhead expenses
|
17,648
|
13,796
|
55,286
|
36,635
|
||||||||||||
Total antisense drug development, excluding non-cash compensation expense related to equity awards
|
45,903
|
33,610
|
148,189
|
110,991
|
||||||||||||
Non-cash compensation expense related to equity awards
|
8,434
|
6,968
|
25,922
|
20,980
|
||||||||||||
Total antisense drug development expenses
|
$
|
54,337
|
$
|
40,578
|
$
|
174,111
|
$
|
131,971
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Ionis Core
|
$
|
20,821
|
$
|
20,521
|
$
|
71,767
|
$
|
74,655
|
||||||||
Akcea Therapeutics
|
25,082
|
13,089
|
76,422
|
84,730
|
||||||||||||
Elimination of intercompany activity
|
—
|
—
|
—
|
(48,394
|
)
|
|||||||||||
Subtotal
|
45,903
|
33,610
|
148,189
|
110,991
|
||||||||||||
Non-cash compensation expense related to equity awards
|
8,434
|
6,968
|
25,922
|
20,980
|
||||||||||||
Total antisense drug development expenses
|
$
|
54,337
|
$
|
40,578
|
$
|
174,111
|
$
|
131,971
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Manufacturing and operations expenses, excluding non-cash compensation expense related to equity awards
|
$
|
8,085
|
$
|
9,167
|
$
|
30,083
|
$
|
26,260
|
||||||||
Non-cash compensation expense related to equity awards
|
2,236
|
1,693
|
7,024
|
5,143
|
||||||||||||
Total manufacturing and operations expenses
|
$
|
10,321
|
$
|
10,860
|
$
|
37,107
|
$
|
31,403
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Ionis Core
|
$
|
6,931
|
$
|
7,743
|
$
|
24,659
|
$
|
23,575
|
||||||||
Akcea Therapeutics
|
1,154
|
1,424
|
10,653
|
8,698
|
||||||||||||
Elimination of intercompany activity
|
—
|
—
|
(5,229
|
)
|
(6,013
|
)
|
||||||||||
Subtotal
|
8,085
|
9,167
|
30,083
|
26,260
|
||||||||||||
Non-cash compensation expense related to equity awards
|
2,236
|
1,693
|
7,024
|
5,143
|
||||||||||||
Total manufacturing and operations expenses
|
$
|
10,321
|
$
|
10,860
|
$
|
37,107
|
$
|
31,403
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Personnel costs
|
$
|
3,259
|
$
|
2,608
|
$
|
9,456
|
$
|
8,174
|
||||||||
Occupancy
|
2,379
|
2,132
|
6,281
|
6,086
|
||||||||||||
Patent expenses
|
513
|
465
|
1,745
|
1,459
|
||||||||||||
Depreciation and amortization
|
115
|
51
|
315
|
175
|
||||||||||||
Insurance
|
364
|
480
|
1,991
|
1,153
|
||||||||||||
Other
|
1,382
|
1,449
|
3,425
|
3,786
|
||||||||||||
Total R&D support expenses, excluding non-cash compensation expense related to equity awards
|
8,012
|
7,185
|
23,213
|
20,833
|
||||||||||||
Non-cash compensation expense related to equity awards
|
3,731
|
3,585
|
11,548
|
10,676
|
||||||||||||
Total R&D support expenses
|
$
|
11,743
|
$
|
10,770
|
$
|
34,761
|
$
|
31,509
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Ionis Core
|
$
|
7,225
|
$
|
6,441
|
$
|
20,464
|
$
|
19,303
|
||||||||
Akcea Therapeutics
|
832
|
774
|
2,865
|
1,620
|
||||||||||||
Elimination of intercompany activity
|
(45
|
)
|
(30
|
)
|
(116
|
)
|
(90
|
)
|
||||||||
Subtotal
|
8,012
|
7,185
|
23,213
|
20,833
|
||||||||||||
Non-cash compensation expense related to equity awards
|
3,731
|
3,585
|
11,548
|
10,676
|
||||||||||||
Total R&D support expenses
|
$
|
11,743
|
$
|
10,770
|
$
|
34,761
|
$
|
31,509
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Selling, general and administrative expenses, excluding non-cash compensation expense related to equity awards
|
$
|
52,609
|
$
|
21,497
|
$
|
139,051
|
$
|
47,583
|
||||||||
Non-cash compensation expense related to equity awards
|
16,103
|
5,291
|
39,512
|
15,199
|
||||||||||||
Total selling, general and administrative expenses
|
$
|
68,712
|
$
|
26,788
|
$
|
178,563
|
$
|
62,782
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Ionis Core
|
$
|
16,060
|
$
|
15,463
|
$
|
54,254
|
$
|
33,561
|
||||||||
Akcea Therapeutics
|
44,450
|
6,034
|
92,248
|
14,022
|
||||||||||||
Elimination of intercompany activity
|
(7,901
|
)
|
—
|
(7,451
|
)
|
—
|
||||||||||
Subtotal
|
52,609
|
21,497
|
139,051
|
—
|
||||||||||||
Non-cash compensation expense related to equity awards
|
16,103
|
5,291
|
39,512
|
15,199
|
||||||||||||
Total selling, general and administrative expenses
|
$
|
68,712
|
$
|
26,788
|
$
|
178,563
|
$
|
62,782
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Development and patent expenses
|
$
|
27,068
|
$
|
15,287
|
$
|
89,940
|
$
|
95,049
|
||||||||
Selling, general and administrative expenses
|
44,450
|
6,034
|
92,248
|
14,022
|
||||||||||||
Total operating expenses, excluding non-cash compensation expense related to equity awards
|
71,518
|
21,321
|
182,188
|
109,071
|
||||||||||||
Non-cash compensation expense related to equity awards
|
12,731
|
4,692
|
31,240
|
11,814
|
||||||||||||
Total Akcea Therapeutics operating expenses
|
$
|
84,249
|
$
|
26,013
|
$
|
213,428
|
$
|
120,885
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2018
|
2017
|
2018
|
2017
|
|||||||||||||
Convertible notes:
|
||||||||||||||||
Non-cash amortization of the debt discount and debt issuance costs
|
$
|
8,856
|
$
|
8,208
|
$
|
26,072
|
$
|
24,165
|
||||||||
Interest expense payable in cash
|
1,714
|
1,714
|
5,141
|
5,373
|
||||||||||||
Non-cash interest expense for long-term financing liability
|
—
|
308
|
—
|
3,660
|
||||||||||||
Interest on mortgage for primary R&D and manufacturing facilities
|
607
|
505
|
1,802
|
505
|
||||||||||||
Other
|
105
|
90
|
317
|
263
|
||||||||||||
Total interest expense
|
$
|
11,282
|
$
|
10,825
|
$
|
33,332
|
$
|
33,966
|
|
Payments Due by Period (in millions)
|
|||||||||||||||||||
Contractual Obligations (selected balances described below)
|
Total
|
Less than 1 year
|
1-3 years
|
3-5 years
|
After 5 years
|
|||||||||||||||
Convertible senior notes (principal and interest payable)
|
$
|
709.4
|
$
|
6.9
|
$
|
13.7
|
$
|
688.8
|
$
|
—
|
||||||||||
Building mortgage payments
|
$
|
81.4
|
$
|
2.4
|
$
|
4.8
|
$
|
5.9
|
$
|
68.3
|
||||||||||
Financing arrangements (principal and interest payable)
|
$
|
12.8
|
$
|
12.8
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||
Other obligations (principal and interest payable)
|
$
|
1.1
|
$
|
0.1
|
$
|
0.1
|
$
|
0.1
|
$
|
0.8
|
||||||||||
Operating leases
|
$
|
26.6
|
$
|
3.1
|
$
|
5.9
|
$
|
5.2
|
$
|
12.4
|
||||||||||
Total
|
$
|
831.3
|
$
|
25.3
|
$
|
24.5
|
$
|
700.0
|
$
|
81.5
|
1 Percent Convertible
Senior Notes
|
||||
Outstanding principal balance
|
$
|
685.5
|
||
Original issue date ($500 million of principal)
|
November 2014
|
|||
Additional issue date ($185.5 million of principal)
|
December 2016
|
|||
Maturity date
|
November 2021
|
|||
Interest rate
|
1 percent
|
|||
Conversion price per share
|
$
|
66.81
|
||
Total shares of common stock subject to conversion
|
10.3
|
(i)
|
a floating rate equal to the one-month London Interbank Offered Rate, or LIBOR, in effect plus 1.25 percent per annum;
|
(ii)
|
a fixed rate equal to LIBOR plus 1.25 percent for a period of one, two, three, four, six, or twelve months as elected by us; or
|
(iii)
|
a fixed rate equal to the LIBOR swap rate during the period of the loan.
|
ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
ITEM 4. |
CONTROLS AND PROCEDURES
|
ITEM 1. |
LEGAL PROCEEDINGS
|
ITEM 1A. |
RISK FACTORS
|
● |
receipt and scope of marketing authorizations;
|
● |
establishment and demonstration in the medical and patient community of the efficacy and safety of our drugs and their potential advantages over competing products;
|
● |
cost and effectiveness of our drugs compared to other available therapies;
|
● |
patient convenience of the dosing regimen for our drugs; and
|
● |
reimbursement policies of government and third-party payors.
|
● |
priced lower than our drugs;
|
● |
reimbursed more favorably by government and other third-party payors than our drugs;
|
● |
safer than our drugs;
|
● |
more effective than our drugs; or
|
● |
more convenient to use than our drugs.
|
● |
In the United States, TEGSEDI’s label contains a boxed warning for thrombocytopenia and glomerulonephritis,
|
● |
TEGSEDI requires periodic blood and urine monitoring, and
|
● |
in the United States TEGSEDI is available only through a Risk Evaluation and Mitigation Strategy, or REMS, program.
|
● |
fund our development activities for SPINRAZA;
|
● |
seek and obtain regulatory approvals for SPINRAZA; and
|
● |
successfully commercialize SPINRAZA.
|
● |
the clinical study may produce negative or inconclusive results;
|
● |
regulators may require that we hold, suspend or terminate clinical research for noncompliance with regulatory requirements;
|
● |
we, our partners, the FDA or foreign regulatory authorities could suspend or terminate a clinical study due to adverse side effects of a drug on subjects in the trial;
|
● |
we may decide, or regulators may require us, to conduct additional preclinical testing or clinical studies;
|
● |
enrollment in our clinical studies may be slower than we anticipate;
|
● |
people who enroll in the clinical study may later drop out due to adverse events, a perception they are not benefiting from participating in the study, fatigue with the clinical study process or personal issues;
|
● |
the cost of our clinical studies may be greater than we anticipate; and
|
● |
the supply or quality of our drugs or other materials necessary to conduct our clinical studies may be insufficient, inadequate or delayed.
|
● |
conduct clinical studies;
|
● |
seek and obtain marketing authorization; and
|
● |
manufacture, market and sell our drugs.
|
● |
pursue alternative technologies or develop alternative products that may be competitive with the drug that is part of the collaboration with us;
|
● |
pursue higher-priority programs or change the focus of its own development programs; or
|
● |
choose to devote fewer resources to our drugs than it does for its own drugs.
|
● |
successful commercialization for SPINRAZA and TEGSEDI;
|
● |
marketing approvals for WAYLIVRA;
|
● |
the profile and launch timing of our drugs, including WAYLIVRA and TEGSEDI;
|
● |
changes in existing collaborative relationships and our ability to establish and maintain additional collaborative arrangements;
|
● |
continued scientific progress in our research, drug discovery and development programs;
|
● |
the size of our programs and progress with preclinical and clinical studies;
|
● |
the time and costs involved in obtaining marketing authorizations; and
|
● |
competing technological and market developments, including the introduction by others of new therapies that address our markets.
|
● |
interruption of our research, development and manufacturing efforts;
|
● |
injury to our employees and others;
|
● |
environmental damage resulting in costly clean up; and
|
● |
liabilities under federal, state and local laws and regulations governing health and human safety, as well as the use, storage, handling and disposal of these materials and resultant waste products.
|
ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
ITEM 3. |
DEFAULT UPON SENIOR SECURITIES
|
ITEM 4. |
MINE SAFETY DISCLOSURES
|
ITEM 5. |
OTHER INFORMATION
|
ITEM 6. |
EXHIBITS
|
a. |
Exhibits
|
Exhibit Number
|
Description of Document
|
|
Second Amendment to Research Collaboration, Option and License Agreement of December 22, 2014, by and between Ionis Pharmaceuticals, Inc. and Janssen Biotech Inc. Portions of this exhibit have been omitted and separately filed with the SEC.
|
||
Certification by Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended.
|
||
Certification by Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended.
|
||
Certification Pursuant to 18 U.S.C. Section 1350 as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
||
101
|
The following financial statements from the Ionis Pharmaceuticals, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, formatted in Extensive Business Reporting Language (XBRL): (i) condensed consolidated balance sheets, (ii) condensed consolidated statements of operations, (iii) condensed consolidated statements of comprehensive income (loss), (iv) condensed consolidated statements of cash flows and (v) notes to condensed consolidated financial statements (detail tagged).
|
* |
This certification is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.
|
Signatures
|
Title
|
Date
|
||
/s/ STANLEY T. CROOKE
|
Chairman of the Board, President, and Chief Executive Officer
|
|||
Stanley T. Crooke, M.D., Ph.D.
|
(Principal executive officer)
|
November 6, 2018
|
||
/s/ ELIZABETH L. HOUGEN
|
Senior Vice President, Finance and Chief Financial Officer
|
|||
Elizabeth L. Hougen
|
(Principal financial and accounting officer)
|
November 6, 2018
|
Ionis Pharmaceuticals, Inc.
2855 Gazelle Court
Carlsbad, CA 92010
Attention: Chief Operating Officer
|
Ionis Pharmaceuticals, Inc.
2855 Gazelle Court
Carlsbad, CA 92010
Attention: General Counsel
|
Re: |
Second Amendment to Research Collaboration, Option and License Agreement of December 22, 2014
|
Very truly yours,
|
||
/s/ Catherine Owen
|
||
Catherine Owen
|
||
President, JBI Biotech, Inc.
|
AGREED & ACCEPTED:
|
|
/s/ Brett Monia
|
|
Name: Brett Monia
|
|
Title: Chief Operating Officer
|
|
Date: August 13, 2018
|
|
Ionis Pharmaceuticals, Inc.
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of Ionis Pharmaceuticals, Inc.;
|
2. |
Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
|
3. |
Based on my knowledge, the condensed consolidated financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, condensed consolidated results of operations and condensed consolidated cash flows of the registrant as of, and for, the periods presented in this quarterly report;
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
|
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Dated: November 6, 2018
|
|
|
|
/s/ STANLEY T. CROOKE
|
|
Stanley T. Crooke, M.D., Ph.D.
|
|
Chief Executive Officer
|
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of Ionis Pharmaceuticals, Inc.;
|
2. |
Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
|
3. |
Based on my knowledge, the condensed consolidated financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, condensed consolidated results of operations and condensed consolidated cash flows of the registrant as of, and for, the periods presented in this quarterly report;
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c) |
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d) |
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
|
a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Dated: November 6, 2018
|
|
|
|
/s/ ELIZABETH L. HOUGEN
|
|
Elizabeth L. Hougen
|
|
Chief Financial Officer
|
|
1. |
The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2018, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and
|
2. |
The information contained in the Periodic Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Periodic Report and the results of operations of the Company for the period covered by the Periodic Report.
|
Dated: November 6, 2018
|
|
|
|
|
|
/s/ STANLEY T. CROOKE
|
|
/s/ ELIZABETH L. HOUGEN
|
Stanley T. Crooke, M.D., Ph.D.
|
|
Elizabeth L. Hougen
|
Chief Executive Officer
|
|
Chief Financial Officer
|
Document and Entity Information - shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2018 |
Oct. 31, 2018 |
|
Document and Entity Information [Abstract] | ||
Entity Registrant Name | IONIS PHARMACEUTICALS INC | |
Entity Central Index Key | 0000874015 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Ex Transition Period | false | |
Entity Common Stock, Shares Outstanding | 137,571,510 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2018 | |
Document Fiscal Period Focus | Q3 |
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares |
Sep. 30, 2018 |
Dec. 31, 2017 |
---|---|---|
Stockholders' equity: | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 137,506,203 | 124,976,373 |
Common stock, shares outstanding (in shares) | 137,506,203 | 124,976,373 |
1 Percent Convertible Senior Notes [Member] | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Interest rate on convertible senior notes | 1.00% | 1.00% |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Unaudited) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2018 |
Sep. 30, 2017 |
Sep. 30, 2018 |
Sep. 30, 2017 |
|
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) [Abstract] | ||||
Net loss | $ (20,365) | $ (7,493) | $ (87,747) | $ (1,616) |
Unrealized gains (losses) on debt securities, net of tax | 133 | 215 | (834) | 610 |
Reclassification adjustment for realized gains included in net income (loss) | 0 | 0 | 0 | (374) |
Currency translation adjustment | (28) | (42) | 61 | (77) |
Comprehensive loss | (20,260) | (7,320) | (88,520) | (1,457) |
Comprehensive loss attributable to noncontrolling interests | 15,797 | 3,952 | 41,455 | 3,952 |
Comprehensive income (loss) attributable to Ionis Pharmaceuticals, Inc. stockholders | $ (4,463) | $ (3,368) | $ (47,065) | $ 2,495 |
Basis of Presentation |
9 Months Ended |
---|---|
Sep. 30, 2018 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | 1. Basis of Presentation We prepared the unaudited interim condensed consolidated financial statements for the three and nine months ended September 30, 2018 and 2017 on the same basis as the audited financial statements for the year ended December 31, 2017. We included all normal recurring adjustments in the financial statements, which we considered necessary for a fair presentation of our financial position at such dates and our operating results and cash flows for those periods. Results for the interim periods are not necessarily indicative of the results for the entire year. For more complete financial information, these financial statements, and notes thereto, should be read in conjunction with the audited financial statements for the year ended December 31, 2017 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC. In the condensed consolidated financial statements, we included the accounts of Ionis Pharmaceuticals, Inc. and the consolidated results of our majority owned affiliate, Akcea Therapeutics, Inc. and its wholly owned subsidiaries, which we formed in December 2014. Prior to Akcea’s initial public offering, or IPO, in July 2017, we owned 100 percent of Akcea. From the closing of Akcea’s IPO in July 2017 through mid-April 2018, we owned approximately 68 percent of Akcea. In the second and third quarters of 2018, we received additional shares of Akcea’s stock related to our license of TEGSEDI and AKCEA-TTR-LRx to Akcea, increasing our ownership percentage to approximately 75 percent. We reflected the increase in our ownership in these financial statements. In October 2018, we received an additional 1.7 million shares of Akcea’s stock when TEGSEDI received marketing authorization in the U.S., increasing our ownership to approximately 76 percent. Refer to the section titled “Noncontrolling Interest in Akcea” in Note 2, Significant Accounting Policies, for further information related to our accounting for our investment in Akcea. Unless the context requires otherwise, “Ionis”, “Company,” “we,” “our,” and “us” refers to Ionis Pharmaceuticals, Inc. and its majority owned affiliate, Akcea Therapeutics, Inc. and its wholly owned subsidiaries. |
Significant Accounting Policies |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Significant Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Significant Accounting Policies | 2. Significant Accounting Policies Revenue Recognition Adoption of New Revenue Recognition Accounting Standard (Topic 606) In May 2014, the FASB issued accounting guidance on the recognition of revenue from customers. This guidance supersedes the revenue recognition requirements we previously followed in Accounting Standards Codification, or ASC, Topic 605, Revenue Recognition, or Topic 605, and created a new Topic 606, Revenue from Contracts with Customers, or Topic 606. Under Topic 606, an entity will recognize revenue when it transfers control of promised goods or services to customers in an amount that reflects what the entity expects to receive in exchange for the goods or services. Further, an entity will recognize revenue upon satisfying the performance obligation(s) under the related contract. We adopted Topic 606 on January 1, 2018 under the full retrospective approach, which required us to revise our prior period revenue. Under Topic 606, we were required to review all of our ongoing collaboration agreements in which we recognized revenue after January 1, 2016. We were required to assess what our revenue would have been for the period from January 1, 2016 to December 31, 2017 under Topic 606. As a result of this analysis, we determined that the cumulative revenue we would have recognized under Topic 606 decreased by $53.6 million. We recorded this amount as a cumulative adjustment to our accumulated deficit as of December 31, 2017. We have labeled our prior period financial statements “as revised” to indicate the change required under the accounting rules. The following tables summarize the adjustments we were required to make to amounts we originally reported in 2017 to adopt Topic 606 (in thousands, except per share amounts): Condensed Consolidated Balance Sheet
Condensed Consolidated Statement of Operations
Condensed Consolidated Statement of Cash Flows
Under Topic 606, compared to Topic 605, our revenue decreased $2.6 million for the three months ended September 30, 2017, and increased $11.0 million for the nine months ended September 30, 2017. The change in our revenue was primarily due to:
Our updated revenue recognition policy reflecting Topic 606 is as follows: Our Revenue Sources We generally recognize revenue when we have satisfied all contractual obligations and are reasonably assured of collecting the resulting receivable. We are often entitled to bill our customers and receive payment from our customers in advance of recognizing the revenue. In the instances in which we have received payment from our customers in advance of recognizing revenue, we include the amounts in deferred revenue on our condensed consolidated balance sheet. Commercial Revenue: SPINRAZA royalties and Licensing and other royalty revenue We earn commercial revenue primarily in the form of royalty payments on net sales of SPINRAZA. We expect to add product sales from TEGSEDI to our commercial revenue in the fourth quarter of 2018 as a result of TEGSEDI’s approval in the U.S., EU and Canada. We will also recognize as commercial revenue future sales milestone payments and royalties we earn under our partnerships. Research and development revenue under collaborative agreements We often enter into collaboration agreements to license and sell our technology on an exclusive or non-exclusive basis. Our collaboration agreements typically contain multiple elements, or performance obligations, including technology licenses or options to obtain technology licenses, research and development, or R&D, services, and manufacturing services. Our collaboration agreements are detailed in Note 6, Collaborative Arrangements and Licensing Agreements. Under each collaboration note we discuss our specific revenue recognition conclusions, including our significant performance obligations under each collaboration. Steps to Recognize Revenue We use a five step process to determine the amount of revenue we should recognize and when we should recognize it. The five step process is as follows:
Accounting rules require us to first determine if we have a contract with our partner, including confirming that we have met each of the following criteria:
We next identify the distinct goods and services we are required to provide under the contract. Accounting rules refer to these as our performance obligations. We typically have only one performance obligation at the inception of a contract, which is to perform R&D services. Often times when we enter into a collaboration agreement in which we provide our partner with an option to license a drug in the future. We may also provide our partner with an option to request that we provide additional goods or services in the future, such as active pharmaceutical ingredient, or API. We evaluate whether these options are material rights at the inception of the agreement. If we determine an option is a material right, we will consider the option a separate performance obligation. Historically, we have concluded that the options we grant to license a drug in the future or to provide additional goods and services as requested by our partner are not material rights. These items are contingent upon future events that may not occur. When a partner exercises its option to license a drug or requests additional goods or services, then we identify a new performance obligation for that item. In some cases, we deliver a license at the start of an agreement. If we determine that our partner has full use of the license and we do not have any additional performance obligations related to the license after delivery, then we consider the license to be a separate performance obligation.
We then determine the transaction price by reviewing the amount of consideration we are eligible to earn under the collaboration agreement, including any variable consideration. Under our collaboration agreements, consideration typically includes fixed consideration in the form of an upfront payment and variable consideration in the form of potential milestone payments, license fees and royalties. At the start of an agreement, our transaction price usually consists of only the upfront payment. We do not typically include any payments we may receive in the future in our initial transaction price because the payments are not probable. We reassess the total transaction price at each reporting period to determine if we should include additional payments in the transaction price. Milestone payments are our most common type of variable consideration. We recognize milestone payments using the most likely amount method because we will either receive the milestone payment or we will not, which makes the potential milestone payment a binary event. The most likely amount method requires us to determine the likelihood of earning the milestone payment. We include a milestone payment in the transaction price once it is probable we will achieve the milestone event. Most often, we do not consider our milestone payments probable until we or our partner achieve the milestone event because the majority of our milestone payments are contingent upon events that are not within our control.
Next, we allocate the transaction price to each of our performance obligations. When we have to allocate the transaction price to more than one performance obligation, we make estimates of the relative stand-alone selling price of each performance obligation because we do not typically sell our goods or services on a stand-alone basis. We then allocate the transaction price to each performance obligation based on the relative stand-alone selling price. We may engage a third party, independent valuation specialist to assist us with determining a stand-alone selling price for collaborations in which we deliver a license at the start of an agreement. We estimate the stand-alone selling price of these licenses using valuation methodologies, such as the relief from royalty method. Under this method, we estimate the amount of income, net of taxes, for the license. We then discount the projected income to present value. The significant inputs we use to determine the projected income of a license could include:
We typically estimate the selling price of R&D services by using our internal estimates of the cost to perform the specific services. The significant inputs we use to determine the selling price of our R&D services include:
For purposes of determining the stand-alone selling price of the R&D services we perform and the API we will deliver, accounting guidance requires us to include a markup for a reasonable profit margin. We do not reallocate the transaction price after the start of an agreement to reflect subsequent changes in stand-alone selling prices.
We recognize revenue in one of two ways, over time or at a point in time. We recognize revenue over time when we are executing on our performance obligation over time and our partner receives benefit over time. For example, we recognize revenue over time when we provide R&D services. We recognize revenue at a point in time when our partner receives full use of an item at a specific point in time. For example, we recognize revenue at a point in time when we deliver a license or API to a partner. For R&D services that we recognize over time, we measure our progress using an input method. The input methods we use are based on the effort we expend or costs we incur toward the satisfaction of our performance obligation. We estimate the amount of effort we expend, including the time we estimate it will take us to complete the activities, or costs we incur in a given period, relative to the estimated total effort or costs to satisfy the performance obligation. This results in a percentage that we multiply by the transaction price to determine the amount of revenue we recognize each period. This approach requires us to make numerous estimates and use significant judgement. If our estimates or judgements change over the course of the collaboration, they may affect the timing and amount of revenue that we recognize in the current and future periods. The following are examples of when we typically recognize revenue based on the types of payments we receive. Commercial Revenue: SPINRAZA royalties and Licensing and other royalty revenue We recognize royalty revenue in the period in which the counterparty sells the related product, which in certain cases may require us to estimate our royalty revenue. We recognize royalties from SPINRAZA sales in the period Biogen records the sale of SPINRAZA. Our accounting for SPINRAZA royalties did not change as a result of adopting Topic 606. Research and development revenue under collaboration agreements: Upfront Payments When we enter into a collaboration agreement with an upfront payment, we typically record the entire upfront payment as deferred revenue if our only performance obligation is for R&D services we will provide in the future. We amortize the upfront payment into revenue as we perform the R&D services. For example, under our new SMA collaboration with Biogen, we received a $25 million upfront payment in December 2017. We allocated the upfront payment to our single performance obligation, R&D services. We are amortizing the $25 million upfront payment using an input method over the estimated period of time we are providing R&D services. Refer to Note 6, Collaborative Arrangements and Licensing Agreements, for further discussion. Under Topic 605, we amortized upfront payments evenly over the period of our obligation. Milestone Payments We typically include milestone payments for R&D services in the transaction price when they are achieved. We include these milestone payments when they are achieved because there is considerable uncertainty in the research and development processes that trigger these payments under our collaboration agreements. Similarly, we include approval milestone payments in the transaction price once the drug is approved by the applicable regulator. We will recognize sales based milestone payments in the period we achieve the milestone under the sales-based royalty exception allowed under accounting rules. We recognize milestone payments that relate to an ongoing performance obligation over our period of performance. For example, in the third quarter of 2017, we initiated a Phase 1/2a clinical study of IONIS-MAPTRx in patients with mild Alzheimer’s disease. We earned a $10 million milestone payment from Biogen related to the initiation of this study. Under Topic 606, we allocated this payment to our R&D services performance obligation. We are recognizing revenue from this milestone payment over our estimated period of performance. Under Topic 605, this milestone payment was recognized in full in the third quarter of 2017, which was the period in which we achieved the milestone event. Conversely, we recognize in full those milestone payments that we earn based on our partners’ activities when our partner achieves the milestone event. For example, in the third quarter of 2018, we earned a $10 million milestone payment when AstraZeneca initiated a Phase 1 study of IONIS-AZ4-2.5-LRx. Our revenue recognition of milestone payments we earn based on our partners’ activities did not change as a result of adopting Topic 606. License Fees We generally recognize as revenue the total amount we determine to be the stand-alone selling price of a license when we deliver the license to our partner. This is because our partner has full use of the license and we do not have any additional performance obligations related to the license after delivery. For example, in the third quarter of 2018, we earned a $12 million license fee when our majority-owned affiliate, Akcea, entered into an exclusive license agreement with PTC Therapeutics to commercialize TEGSEDI and WAYLIVRA in Latin America. Our recognition of license fees did not change as a result of adopting Topic 606. Amendments to Agreements From time to time we amend our collaboration agreements. When this occurs, we are required to assess the following items to determine the accounting for the amendment:
If we conclude the goods and/or services in the amendment are distinct from the performance obligations in the original agreement and at a stand-alone selling price, we account for the amendment as a separate agreement. If we conclude the goods and/or services are not distinct and at their standalone selling price, we then assess whether the remaining goods or services are distinct from those already provided. If the goods and/or services are distinct from what we have already provided, then we allocate the remaining transaction price from the original agreement and the additional transaction price from the amendment to the remaining goods and/or services. If the goods and/or services are not distinct from what we have already provided, we update the transaction price for our single performance obligation and recognize any change in our estimated revenue as a cumulative adjustment. For example, in May 2015, we entered into an exclusive license agreement with Bayer to develop and commercialize IONIS-FXIRx for the prevention of thrombosis. As part of the agreement, Bayer paid us a $100 million upfront payment. At the onset of the agreement, we were responsible for completing a Phase 2 study of IONIS-FXIRx in people with end-stage renal disease on hemodialysis and for providing an initial supply of API. In February 2017, we amended our agreement with Bayer to advance IONIS-FXIRx and to initiate development of IONIS-FXI-LRx, which Bayer licensed. As part of the 2017 amendment, Bayer paid us $75 million. We are also eligible to receive milestone payments and tiered royalties on gross margins of IONIS-FXIRx and IONIS-FXI-LRx. Under the 2017 amendment, we concluded we had a new agreement with three performance obligations. These performance obligations were to deliver the license of IONIS-FXI-LRx, to provide R&D services and to deliver API. We allocated the $75 million transaction price to these performance obligations. Refer to Note 6, Collaborative Arrangements and Licensing Agreements, for further discussion of our accounting treatment for our Bayer collaboration. Our allocation of the consideration we received for the Bayer amendment did not change as a result of adopting Topic 606. However, the method in which we are recognizing revenue related to our R&D services performance obligation did change. We are amortizing revenue related to our R&D services performance obligation using the input method under Topic 606. Multiple Agreements From time to time, we may enter into separate agreements at or near the same time with the same partner. We evaluate such agreements to determine whether we should account for them individually as distinct arrangements or whether the separate agreements should be combined and accounted for together. We evaluate the following to determine the accounting for the agreements:
Our evaluation involves significant judgment to determine whether a group of agreements might be so closely related that accounting guidance requires us to account for them as a combined arrangement. For example, in the second quarter of 2018, we entered into two separate agreements with Biogen at the same time: a new strategic neurology collaboration agreement and a stock purchase agreement, or SPA. We evaluated the Biogen agreements to determine whether we should treat the agreements separately or combine them. We considered that the agreements were negotiated concurrently and in contemplation of one another. Based on these facts and circumstances, we concluded that we should evaluate the provisions of the agreements on a combined basis. Refer to Note 6, Collaborative Arrangements and Licensing Agreements for further discussion of the accounting treatment for the 2018 strategic neurology collaboration with Biogen. Contracts Receivable Our contracts receivable balance represents the amounts we have billed our partners for goods we have delivered or services we have performed that are due to us unconditionally. When we bill our partners with payment terms based on the passage of time, we consider the contract receivable to be unconditional. We typically receive payment within one quarter of billing our partner. Our contracts receivable balance as of December 31, 2017 did not change when we adopted Topic 606. Unbilled SPINRAZA Royalties Our unbilled SPINRAZA royalties represent our right to receive consideration from Biogen in advance of when we are eligible to bill Biogen for SPINRAZA royalties. We include these unbilled amounts in other current assets on our condensed consolidated balance sheet. Our unbilled SPINRAZA royalties as of December 31, 2017 did not change when we adopted Topic 606. Deferred Revenue We are often entitled to bill our customers and receive payment from our customers in advance of our obligation to provide services or transfer goods to our partners. In these instances, we include the amounts in deferred revenue on our condensed consolidated balance sheet. During the three and nine months ended September 30, 2018, we recognized $37.2 million and $80.4 million of revenue from amounts that were in our beginning deferred revenue balances for those periods, respectively. During the three and nine months ended September 30, 2017, we recognized $31.6 million and $84.4 million of revenue from amounts that were in our beginning deferred revenue balances for those periods, respectively. Refer to our revenue recognition policy above detailing how we recognize revenue for further discussion. The following table summarizes the adjustments we were required to make to our deferred revenue amounts to adopt Topic 606 (in thousands):
Our deferred revenue balance increased $54.2 million at December 31, 2017 under Topic 606, compared to Topic 605. The increase was primarily related to the change in the accounting for certain milestone payments and the way in which we amortize payments. Under Topic 605, we previously recognized the majority of the milestone payments we earned in the period we achieved the milestone event, which did not impact our deferred revenue balance. Under Topic 606 we are now amortizing more milestone payments over the period of our performance obligation, which adds to our deferred revenue balance. Additionally, under Topic 605 we amortized payments evenly over the period of our obligation. Under Topic 606, we are required to use an input method to determine the amount we amortize each reporting period. The increase in deferred revenue relates to agreements with the following partners:
Noncontrolling Interest in Akcea Therapeutics, Inc. Prior to Akcea’s IPO in July 2017, we owned 100 percent of Akcea. From the closing of Akcea’s IPO in July 2017 through mid-April 2018, we owned approximately 68 percent of Akcea. In the second and third quarters of 2018, we received additional shares of Akcea’s stock related to our license of TEGSEDI and AKCEA-TTR-LRx to Akcea, increasing our ownership percentage to approximately 75 percent. We reflected this increase in our ownership percentage in these financial statements as an adjustment to noncontrolling interest. In October 2018, we received an additional 1.7 million shares of Akcea’s stock when TEGSEDI received marketing authorization in the U.S., increasing our ownership to approximately 76 percent. The shares third parties own represent an interest in Akcea’s equity that is not controlled by us. However, as we continue to maintain overall control of Akcea through our voting interest, we reflect the assets, liabilities and results of operations of Akcea in our consolidated financial statements. We reflect the noncontrolling interest attributable to other owners of Akcea’s common stock in a separate line on the statement of operations and a separate line within stockholders’ equity in our condensed consolidated balance sheet. In addition, we record a noncontrolling interest adjustment to account for the stock options Akcea grants, which if exercised, will dilute our ownership in Akcea. This adjustment is a reclassification within stockholders’ equity from additional paid-in capital to noncontrolling interest in Akcea equal to the amount of stock-based compensation expense Akcea had recognized. Cash, cash equivalents and investments We consider all liquid investments with maturities of three months or less when we purchase them to be cash equivalents. Our short-term investments have initial maturities of greater than three months from date of purchase. We classify our short-term debt investments as “available-for-sale” and carry them at fair market value based upon prices on the last day of the fiscal period for identical or similar items. We record unrealized gains and losses on debt securities as a separate component of comprehensive income (loss) and include net realized gains and losses in gain (loss) on investments. We use the specific identification method to determine the cost of securities sold. We also have equity investments of less than 20 percent ownership in publicly and privately held biotechnology companies that we received as part of a technology license or partner agreement. At September 30, 2018, we held an equity investment in one publicly held company, Antisense Therapeutics Limited, or ATL. We also held equity investments in four privately-held companies, Atlantic Pharmaceuticals Limited, Dynacure SAS, Seventh Sense Biosystems and Suzhou Ribo Life Science Co, Ltd. In January 2018, we adopted the amended accounting guidance related to the recognition, measurement, presentation, and disclosure of certain financial instruments. The amended guidance requires us to measure and record our equity investments at fair value. Additionally, the amended accounting guidance requires us to recognize the changes in fair value in our consolidated statement of operations, instead of through accumulated other comprehensive income. Prior to 2018, we accounted for our equity investments in privately held companies under the cost method of accounting. Under the amended guidance we account for our equity investments in privately held companies at their cost minus impairments, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer. Our adoption of this guidance did not have an impact on our results. Inventory valuation We reflect our inventory on our consolidated balance sheet at the lower of cost or market value under the first-in, first-out method, or FIFO. We capitalize the costs of raw materials that we purchase for use in producing our drugs because until we use these raw materials they have alternative future uses. We include in inventory raw material costs for drugs that we manufacture for our partners under contractual terms and that we use primarily in our clinical development activities and drug products. We can use each of our raw materials in multiple products and, as a result, each raw material has future economic value independent of the development status of any single drug. For example, if one of our drugs failed, we could use the raw materials for that drug to manufacture our other drugs. We expense these costs as R&D expenses when we begin to manufacture API for a particular drug if the drug has not been approved for marketing by a regulatory agency. We obtained the first regulatory approval for TEGSEDI in July 2018. At September 30, 2018 and December 31, 2017, our physical inventory for TEGSEDI included API that we produced prior to when we obtained regulatory approval and accordingly has no cost basis as we had previously expensed the costs as R&D expenses. We review our inventory periodically and reduce the carrying value of items we consider to be slow moving or obsolete to their estimated net realizable value based on forecasted demand compared to quantities on hand. We consider several factors in estimating the net realizable value, including shelf life of our inventory, alternative uses for our drugs and historical write-offs. We did not record any inventory write-offs for the nine months ended September 30, 2018 and 2017. Research, development and patent expenses Our research and development expenses include wages, benefits, facilities, supplies, external services, clinical trial and manufacturing costs and other expenses that are directly related to our research and development operations. We expense research and development costs as we incur them. When we make payments for research and development services prior to the services being rendered, we record those amounts as prepaid assets on our condensed consolidated balance sheet and we expense them as the services are provided. We capitalize costs consisting principally of outside legal costs and filing fees related to obtaining patents. We amortize patent costs over the useful life of the patent, beginning with the date the United States Patent and Trademark Office, or foreign equivalent, issues the patent. We review our capitalized patent costs regularly to ensure that they include costs for patents and patent applications that have future value. We evaluate patents and patent applications that we are not actively pursuing and write off any associated costs. Long-lived assets We evaluate long-lived assets, which include property, plant and equipment and patent costs acquired from third parties, for impairment on at least a quarterly basis and whenever events or changes in circumstances indicate that we may not be able to recover the carrying amount of such assets. Use of estimates The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the amounts reported in our condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Basic and diluted net income (loss) per share Basic net income (loss) per share We compute basic net income (loss) per share by dividing the total net income (loss) attributable to our common stockholders by our weighted-average number of common shares outstanding during the period. The calculation of total net income (loss) attributable to our common stockholders for the three and nine months ended September 30, 2018 and 2017 considered our net income for Ionis on a stand-alone basis plus our share of Akcea’s net loss for the period. To calculate the portion of Akcea’s net loss attributable to our ownership, we multiplied Akcea’s loss per share by the weighted average shares we owned in Akcea during the period. As a result of this calculation, our total net income (loss) available to Ionis common stockholders for the calculation of net income (loss) per share is different than net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders in the condensed consolidated statements of operations. Our basic net loss per share for the three months ended September 30, 2018, was calculated as follows (in thousands, except per share amounts):
Akcea’s net loss per share calculation for the nine months ended September 30, 2018 included two components: (1) Akcea’s net loss from its statement of operations and (2) deemed distributions related to the license of TEGSEDI in the second quarter of 2018. Because we own more than 50 percent of Akcea, we and Akcea are under common control. As such, Akcea accounted for the TEGSEDI transaction using common control guidance. Accordingly, Akcea recorded the license we granted to them at carrying value. In addition, Akcea recorded the consideration it paid to us in excess of the carrying value as a deemed distribution. Accounting rules required Akcea to include these deemed distributions in their net loss per share calculation as if Akcea had paid us a dividend. Our basic net loss per share for the nine months ended September 30, 2018, was calculated as follows (in thousands, except per share amounts):
Prior to Akcea’s IPO in July 2017, we owned Akcea series A convertible preferred stock, which included a six percent cumulative dividend. Upon completion of Akcea’s IPO in July 2017, our preferred stock was converted into common stock on a 1:1 basis. The preferred stock dividend was not paid at the IPO because the IPO was not a liquidation event or a change in control. During the three and nine months ended September 30, 2017, Akcea used a two-class method to compute its net income (loss) per share because it had both common and preferred shares outstanding during the periods. The two-class method required Akcea to calculate its net income (loss) per share for each class of stock by dividing total distributable losses applicable to preferred and common stock, including the six percent cumulative dividend contractually due to series A convertible preferred shareholders, by the weighted-average of preferred and common shares outstanding during the requisite period. Since Akcea used the two-class method, accounting rules required us to include our portion of Akcea's net income (loss) per share for both Akcea's common and preferred shares that we owned in our calculation of basic and diluted net income (loss) per share for three and nine months ended September 30, 2017. Our basic net income per share for the three months ended September 30, 2017, was calculated as follows (in thousands, except per share amounts):
Our basic net income per share for the nine months ended September 30, 2017, was calculated as follows (in thousands, except per share amounts):
Dilutive net income (loss per share) For the three and nine months ended September 30, 2018 and for the three months ended September 30, 2017, we incurred a net loss; therefore, we did not include dilutive common equivalent shares in the computation of diluted net loss per share because the effect would have been anti-dilutive. Common stock from the following would have had an anti-dilutive effect on net loss per share:
For the nine months ended September 30, 2017, we had net income available to Ionis common stockholders. As a result, we computed diluted net income per share using the weighted-average number of common shares and dilutive common equivalent shares outstanding during those periods. Diluted common equivalent shares for the nine months ended September 30, 2017 consisted of the following (in thousands except per share amounts):
For the nine months ended September 30, 2017, the calculation excluded the 1 percent and 2¾ percent notes because the effect on diluted earnings per share was anti-dilutive. Accumulated other comprehensive loss We include unrealized gains and losses on investments, net of taxes, in accumulated other comprehensive income (loss) along with adjustments we make to reclassify realized gains and losses on investments from other accumulated comprehensive income (loss) to our condensed consolidated statement of operations. The following table summarizes changes in accumulated other comprehensive income (loss) for the three and nine months ended September 30, 2018 and 2017 (in thousands):
Convertible debt We account for convertible debt instruments that may be settled in cash upon conversion (including partial cash settlement) by separating the liability and equity components of the instruments in a manner that reflects our nonconvertible debt borrowing rate. We determine the carrying amount of the liability component by measuring the fair value of similar debt instruments that do not have the conversion feature. If no similar debt instrument exists, we estimate fair value by using assumptions that market participants would use in pricing a debt instrument, including market interest rates, credit standing, yield curves and volatilities. To determine the fair value of the debt component we are required to use accounting estimates and assumptions. These estimates and assumptions are judgmental in nature and could have a significant impact on the determination of the debt component, and the associated non-cash interest expense. We assigned a value to the debt component of our convertible notes equal to the estimated fair value of similar debt instruments without the conversion feature, which resulted in us recording our debt at a discount. We are amortizing our debt issuance costs and debt discount over the life of the convertible notes as additional non-cash interest expense utilizing the effective interest method. Segment information We have two operating segments, our Ionis Core segment and Akcea Therapeutics, our majority owned affiliate. Akcea is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with rare and serious diseases. We provide segment financial information and results for our Ionis Core segment and our Akcea Therapeutics segment based on the segregation of revenues and expenses that our chief decision maker reviews to assess operating performance and to make operating decisions. We allocate a portion of Ionis’ development, R&D support and general and administrative expenses to Akcea for work Ionis performs on behalf of Akcea. Stock-based compensation expense We measure stock-based compensation expense for equity-classified awards, principally related to stock options, restricted stock units, or RSUs, and stock purchase rights under our ESPP, based on the estimated fair value of the award on the date of grant. We recognize the value of the portion of the award that we ultimately expect to vest as stock-based compensation expense over the requisite service period in our condensed consolidated statements of operations. We reduce stock-based compensation expense for estimated forfeitures at the time of grant and revise in subsequent periods if actual forfeitures differ from those estimates. We use the Black-Scholes model to estimate the fair value of stock options granted and stock purchase rights under our ESPP. The expected term of stock options granted represents the period of time that we expect them to be outstanding. We estimate the expected term of options granted based on historical exercise patterns. For the nine months ended September 30, 2018 and 2017, we used the following weighted-average assumptions in our Black-Scholes calculations: Employee Stock Options:
Board of Director Stock Options:
ESPP:
The fair value of RSUs is based on the market price of our common stock on the date of grant. RSUs vest annually over a four-year period. The weighted-average grant date fair value of RSUs granted to employees and members of our board of directors for the nine months ended September 30, 2018 was $51.83 and $42.88 per share, respectively. The following table summarizes stock-based compensation expense for the three and nine months ended September 30, 2018 and 2017 (in thousands). Our consolidated non-cash stock-based compensation expense includes $12.7 million and $4.7 million of stock-based compensation expense for Akcea for the three months ended September 30, 2018 and 2017, respectively, and $31.2 million and $11.8 million for the nine months ended September 30, 2018 and 2017, respectively.
As of September 30, 2018, total unrecognized estimated non-cash stock-based compensation expense related to non-vested stock options and RSUs was $139.5 million and $32.6 million, respectively. We will adjust total unrecognized compensation cost for future forfeitures. We expect to recognize the cost of non-cash stock-based compensation expense related to non-vested stock options and RSUs over a weighted average amortization period of 1.3 years and 1.6 years, respectively. Impact of recently issued accounting standards In February 2016, the FASB issued amended accounting guidance related to lease accounting, which will require us to record all leases with a term longer than one year on our balance sheet. When we record leases on our balance sheet under the new guidance, we will record a liability with a value equal to the present value of payments we will make over the life of the lease and an asset representing the underlying leased asset. The new accounting guidance requires us to determine if our leases are operating or financing leases. We will record expense for operating leases on a straight-line basis as an operating expense. If we determine a lease is a financing lease, we will record both interest and amortization expense and generally the expense will be higher in the earlier periods of the lease. The new lease standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted. We will adopt this guidance on January 1, 2019. We can choose from two methods of adoption. The first method requires us to reflect our leases on our balance sheet in the earliest comparative period presented in our financial statements. The second method requires us to reflect the impact of adoption on the date we adopt the new guidance and recognize a cumulative-effect adjustment to the opening balance of our accumulated deficit in that period. We are currently determining the method we will use to adopt the new guidance and assessing the effects the new guidance will have on our consolidated financial statements and disclosures. In June 2016, the FASB issued guidance that changes the measurement of credit losses for most financial assets and certain other instruments. If we have credit losses, this updated guidance requires us to record allowances for these instruments under a new expected credit loss model. This model requires us to estimate the expected credit loss of an instrument over its lifetime, which represents the portion of the amortized cost basis we do not expect to collect. The new guidance requires us to remeasure our allowance in each reporting period we have credit losses. The new standard is effective for annual and interim periods beginning after December 15, 2019. Early adoption is permitted for periods beginning after December 15, 2018. When we adopt the new standard, we will make any adjustments to beginning balances through a cumulative-effect adjustment to accumulated deficit on that date. We plan to adopt this guidance on January 1, 2020. We are currently assessing the effects it will have on our consolidated financial statements and disclosures. In December 2017, the SEC staff issued guidance to address how companies should account for the Tax Act of 2017, or the Tax Act, when an entity does not have the necessary information to complete the accounting for the Tax Act and gives entities up to one year from the enactment of the Tax Act to finalize their amounts. We recognized provisional amounts in our 2017 financial statements and in these financial statements. The ultimate impact may differ materially from these provisional amounts due to, among other things, additional analysis, changes in our interpretations and assumptions, additional regulatory guidance that may be issued, and other actions we may take resulting from the Tax Act. We will assess and update our provisional amounts and disclosures, as necessary, at year end 2018. In February 2018, the FASB issued updated guidance for reclassification of tax effects from accumulated other comprehensive income (loss). The updated guidance gives entities an option to reclassify amounts included in accumulated other comprehensive income (loss) that under the Tax Act do not have a way to be relieved, and allows a one-time reclassification to retained earnings. The updated guidance is effective for all entities for fiscal years beginning after December 31, 2018, and interim periods within those fiscal years. Early adoption is permitted, and adoption is optional. We are currently assessing the effects this updated guidance could have on our consolidated financial statements and timing of potential adoption. In June 2018, the FASB issued updated guidance to simplify the accounting for stock-based compensation expense for nonemployees. Specifically, we are now expensing grants to nonemployees in a similar manner as grants to employees and our Board of Directors. Previously, we had to re-value these grants at each reporting period to reflect the current fair value. Under the amended guidance, we value grants to nonemployees when we grant them and we will not adjust their value for future changes. We adopted this guidance in the second quarter of 2018 on a prospective basis. The updated guidance did not have a material impact to our financial results. In August 2018, the FASB issued clarifying guidance on how to account for implementation costs related to cloud-servicing arrangements. The guidance states that if these fees qualify to be capitalized and amortized over the service period, they need to be expensed in the same line item as the service expense and recognized in the same balance sheet category. The update can be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The updated guidance is effective for fiscal years beginning after December 31, 2019, and interim periods within those fiscal years. Early adoption is permitted in any interim period. We are currently assessing the effects this updated guidance could have on our consolidated financial statements and timing of adoption. In August 2018, the FASB updated its disclosure requirements related to Level 1, 2 and 3 fair value measurements. The update included deletion and modification of certain disclosure requirements and additional disclosure related to Level 3 measurements. The guidance is effective for fiscal years beginning after December 31, 2019 and early adoption is permitted. We anticipate we will adopt this updated guidance on January 1, 2019 and we do not expect it to have a significant impact on our disclosures. |
Investments |
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Investments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments | 3. Investments As of September 30, 2018, we had invested our excess cash primarily in debt instruments of the U.S. Treasury, financial institutions, corporations, and U.S. government agencies with strong credit ratings and an investment grade rating at or above A-1, P-1 or F-1 by Moody’s, Standard & Poor’s, or S&P, or Fitch, respectively. We have established guidelines relative to diversification and maturities that maintain safety and liquidity. We periodically review and modify these guidelines to maximize trends in yields and interest rates without compromising safety and liquidity. The following table summarizes the contract maturity of the available-for-sale securities we held as of September 30, 2018:
As illustrated above, at September 30, 2018, 95 percent of our available-for-sale securities had a maturity of less than two years. All of our available-for-sale securities are available to us for use in our current operations. As a result, we categorize all of these securities as current assets even though the stated maturity of some individual securities may be one year or more beyond the balance sheet date. At September 30, 2018, we had an ownership interest of less than 20 percent in four private companies and one public company with which we conduct business. The privately-held companies are Atlantic Pharmaceuticals Limited, Dynacure SAS, Seventh Sense Biosystems and Suzhou Ribo Life Science Co, Ltd. The publicly-traded company is Antisense Therapeutics Limited. The following is a summary of our investments (in thousands):
The following is a summary of our investments we consider to be temporarily impaired at September 30, 2018. We believe that the decline in value of these securities is temporary and is primarily related to the change in market interest rates since purchase. We believe it is more likely than not that we will be able to hold our debt securities to maturity. Therefore, we anticipate full recovery of our debt securities’ amortized cost basis at maturity.
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Fair Value Measurements |
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Fair Value Measurements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | 4. Fair Value Measurements We use a three-tier fair value hierarchy to prioritize the inputs used in our fair value measurements. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets for identical assets, which includes our money market funds and treasury securities classified as available-for-sale securities and our investment in equity securities in publicly-held biotechnology companies; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable, which includes our fixed income securities and commercial paper classified as available-for-sale securities; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring us to develop our own assumptions. We classify the majority of our securities as Level 2. We obtain the fair value of our Level 2 investments from our custodian bank or from a professional pricing service. We validate the fair value of our Level 2 investments by understanding the pricing model used by the custodian banks or professional pricing service provider and comparing that fair value to the fair value based on observable market prices. During the nine months ended September 30, 2018, there were no transfers between our Level 1 and Level 2 investments. When we recognize transfers between levels of the fair value hierarchy, we recognize the transfer on the date the event or change in circumstances that caused the transfer occurs. The following tables present the major security types we held at September 30, 2018 and December 31, 2017 that are regularly measured and carried at fair value. At September 30, 2018 and December 31, 2017, we did not have any financial instruments that we valued using Level 3 inputs. The tables segregate each security type by the level within the fair value hierarchy of the valuation techniques we utilized to determine the respective securities’ fair value (in thousands):
Other Fair Value Disclosures Novartis Future Stock Purchase In January 2017, we and Akcea entered into a SPA with Novartis. As part of the SPA, Novartis was required to purchase $50 million of Akcea’s common stock at the IPO price or our common stock at a premium if an IPO did not occur by April 2018. Therefore, at the inception of the SPA, we recorded a $5.0 million asset representing the fair value of the potential future premium we could have received if Novartis purchased our common stock. We determined the fair value of the future premium by calculating the value based on the stated premium in the SPA and estimating the probability of an Akcea IPO. We also included a lack of marketability discount when we determined the fair value of the premium because we would have issued unregistered shares to Novartis if they had purchased our common stock. We measured this asset using Level 3 inputs and recorded it in other assets on our consolidated balance sheet. Because Akcea completed its IPO before April 2018, Novartis did not purchase additional shares of Ionis stock. Therefore, we wrote-off the remaining balance to other expenses in the third quarter of 2017 because this asset no longer had any value. The following is a reconciliation of the potential premium we would have received if Akcea had not completed its IPO, measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the nine months ended September 30, 2017 (in thousands):
Convertible Notes Our 1 percent notes had a fair value of $725.7 million at September 30, 2018. We determine the fair value of our notes based on quoted market prices for these notes, which are Level 2 measurements because the notes do not trade regularly. |
Other Obligations |
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Other Obligations [Abstract] | |||||||
Other Obligations | 5. Other Obligations Line of Credit Arrangement In June 2015, we entered into a five-year revolving line of credit agreement with Morgan Stanley Private Bank, National Association, or Morgan Stanley. We amended the credit agreement in February 2016 to increase the amount available for us to borrow. Under the amended credit agreement, we can borrow up to a maximum of $30 million of revolving credit for general working capital purposes. Under the credit agreement interest is payable monthly in arrears on the outstanding principal at a borrowing rate based on our option of:
Additionally, we pay 0.25 percent per annum, payable quarterly in arrears, for any amount unused under the credit facility. As of September 30, 2018 we had $12.5 million in outstanding borrowings under the credit facility with a 2.31 percent fixed interest rate and a maturity date of September 2019, which we used to fund our capital equipment needs consistent with our historical practice to finance these costs. The credit agreement includes customary affirmative and negative covenants and restrictions. We are in compliance with all covenants of the credit agreement. Research and Development and Manufacturing Facilities In July 2017, we purchased the building that houses our primary R&D facility and the building that houses our manufacturing facility for $79.4 million and $14.0 million, respectively. We financed the purchase of our primary R&D facility and our manufacturing facility, with mortgage debt of $51.3 million and $9.1 million, respectively. Our primary R&D facility mortgage has an interest rate of 3.88 percent. Our manufacturing facility has an interest rate of 4.20 percent. During the first five years of both mortgages, we are only required to make interest payments. Both mortgages mature in August 2027. |
Collaborative Arrangements and Licensing Agreements |
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Collaborative Arrangements and Licensing Agreements | 6. Collaborative Arrangements and Licensing Agreements Below, we have included all of our significant collaborations because we adopted Topic 606 on January 1, 2018. We have included new disclosures for each of our collaborations as required under Topic 606. Strategic Partnership Biogen We have several strategic collaborations with Biogen focused on using antisense technology to advance the treatment of neurological disorders. These collaborations combine our expertise in creating antisense drugs with Biogen's expertise in developing therapies for neurological disorders. We developed and licensed to Biogen SPINRAZA, our approved drug to treat people with spinal muscular atrophy, or SMA. In December 2017, we entered into a collaboration with Biogen to identify new antisense drugs for the treatment of SMA. Additionally, we and Biogen are currently developing six other drugs to treat neurodegenerative diseases under these collaborations, including IONIS-SOD1Rx for ALS, IONIS-MAPTRx for Alzheimer’s disease, IONIS-C9Rx for ALS, and IONIS-BIIB6Rx, IONIS-BIIB7Rx and IONIS-BIIB8Rx to treat undisclosed neurodegenerative diseases. In addition to these drugs, we and Biogen are evaluating numerous additional targets to develop drugs to treat neurological diseases. Most recently, in April 2018, we entered into a new strategic collaboration for the treatment of neurological diseases with Biogen. From inception through September 2018, we have received over $1.9 billion from our Biogen collaborations, including $1 billion we received from Biogen in the second quarter of 2018 when we entered into the 2018 strategic neurology collaboration. SPINRAZA In January 2012, we entered into a collaboration agreement with Biogen to develop and commercialize SPINRAZA, an RNA-targeted therapy for the treatment of SMA. In December 2016, the FDA approved SPINRAZA for the treatment of SMA in pediatric and adult patients. From inception through September 2018, we earned $717 million in total revenue under our SPINRAZA collaboration, including $281 million in revenue from SPINRAZA royalties and $436 million in R&D revenue. We are receiving tiered royalties ranging from 11 percent to 15 percent on any sales of SPINRAZA. We have exclusively in-licensed patents related to SPINRAZA from Cold Spring Harbor Laboratory and the University of Massachusetts. We pay Cold Spring Harbor Laboratory and the University of Massachusetts a low single digit royalty on sales of SPINRAZA. Biogen is responsible for all further global development, regulatory and commercialization activities and costs for SPINRAZA. Over the course of our SPINRAZA collaboration, we identified two performance obligations, which were to perform R&D services and to deliver the SPINRAZA license to Biogen. As we achieved milestone payments for our R&D services, we included these amounts in our transaction price for our R&D services performance obligation. We recognized revenue for our R&D services performance obligation over our period of performance through December 2016. We recognized the $75 million license fee for SPINRAZA as revenue when we delivered the license to Biogen in July 2016 because Biogen had full use of the license without any continuing involvement from us. Additionally, we did not have any further performance obligations related to the license after we delivered it to Biogen. We also earned additional milestone payments subsequent to delivering the license to Biogen that we recognized in full in the period each milestone payment became probable because we did not have a performance obligation related to each milestone payment. For example, we received $90 million of milestone payments for the approval of SPINRAZA in the EU and Japan in 2017 and recognized the full amounts into revenue in the period Biogen achieved the milestone events. Neurology In December 2012, we and Biogen entered into a collaboration agreement to develop and commercialize novel antisense drugs to up to three targets to treat neurodegenerative diseases. We are responsible for the development of each of the drugs through the completion of the initial Phase 2 clinical study for such drug. Biogen has the option to license a drug from each of the three programs through the completion of the first Phase 2 study for each program. We are currently advancing IONIS-MAPTRx for Alzheimer’s disease under this collaboration. If Biogen exercises its option for a drug, it will assume all further global development, regulatory and commercialization responsibilities and costs for that drug. Under the terms of the agreement, we received an upfront payment of $30 million. Over the term of the collaboration, we are eligible to receive up to $210 million in a license fee and milestone payments per program, plus a mark-up on the cost estimate of the Phase 1 and 2 studies. The $210 million per program consists of up to $10 million in development milestone payments, plus a mark-up on the cost estimate of the Phase 1 and 2 studies and up to $130 million in milestone payments if Biogen achieves pre-specified regulatory milestones. In addition, we are eligible to receive tiered royalties up to the mid-teens on sales of any drugs resulting from each of the three programs. From inception through September 2018, we have received $58 million in milestone payments and upfront fees under this collaboration. We will achieve the next payment of $7.5 million if we continue to advance IONIS-MAPTRx. At the commencement of this collaboration, we identified one performance obligation, which was to perform R&D services for Biogen. At inception, we determined the transaction price to be the $30 million upfront payment we received and allocated it to our single performance obligation. As we achieve milestone payments for our R&D services, we include these amounts in our transaction price for our R&D services performance obligation. We are recognizing revenue for our R&D services performance obligation as we perform services based on our effort to satisfy our performance obligation relative to our total effort expected to satisfy our performance obligation. We currently estimate we will satisfy our performance obligation in December 2020. From inception through September 2018, we have included $40 million in total payments in the transaction price for our R&D services performance obligation. 2013 Strategic Neurology In September 2013, we and Biogen entered into a long-term strategic relationship focused on applying antisense technology to advance the treatment of neurodegenerative diseases. As part of the collaboration, Biogen gained exclusive rights to the use of our antisense technology to develop therapies for neurological diseases and has the option to license drugs resulting from this collaboration. The exclusivity for neurological diseases will last through September 2019, and may be extended for any drug development programs Biogen is pursuing under the collaboration. We will usually be responsible for drug discovery and early development of antisense drugs and Biogen will have the option to license antisense drugs after Phase 2 proof of concept. In October 2016, we expanded our collaboration to include additional research activities we will perform. If Biogen exercises its option for a drug, it will assume all further global development, regulatory and commercialization responsibilities and costs for that drug. We are currently advancing five drugs, IONIS-SOD1Rx, IONIS-C9Rx, IONIS-BIIB6Rx, IONIS-BIIB7Rx and IONIS-BIIB8Rx under this collaboration. Biogen will be responsible for all of the drug discovery and development activities for drugs using other modalities. Under the terms of the agreement, we received an upfront payment of $100 million and are eligible to receive milestone payments, license fees and royalty payments for all drugs developed through this collaboration, with the specific amounts dependent upon the modality of the molecule advanced by Biogen. For each antisense molecule that is chosen for drug discovery and development under this collaboration, we are eligible to receive up to approximately $260 million in a license fee and milestone payments per program. The $260 million per program consists of approximately $60 million in development milestones, including amounts related to the cost of clinical trials, and up to $130 million in milestone payments if Biogen achieves pre-specified regulatory milestones. In addition, we are eligible to receive tiered royalties up to the mid-teens on sales from any antisense drugs developed under this collaboration. If Biogen chooses to advance drugs using other modalities, such as small molecules or monoclonal antibodies, we are eligible to receive up to $90 million in milestone payments per program. The $90 million per program consists of up to $35 million in development milestone payments and up to $55 million in milestone payments if Biogen achieves pre-specified regulatory milestones. In addition, we are eligible to receive tiered single-digit royalties on sales from any drugs using non-antisense modalities developed under this collaboration. From inception through September 2018, we have received over $170 million in upfront fees, milestone payments and other payments under this collaboration, not including a $10 million milestone payment we earned in the third quarter of 2018 for Biogen’s initiation of a Phase 1 study for IONIS-C9Rx which we received in the fourth quarter of 2018. We will achieve the next payment of up to $10 million if we advance a program under this collaboration. At the commencement of our strategic neurology collaboration, we identified one performance obligation, which was to perform R&D services for Biogen. At inception, we determined the transaction price to be the $100 million upfront payment we received and allocated it to our single performance obligation. As we achieve milestone payments for our R&D services, we include these amounts in our transaction price for our R&D services performance obligation. We are recognizing revenue for our R&D services performance obligation based on our effort to satisfy our performance obligation relative to our total effort expected to satisfy our performance obligation. We currently estimate we will satisfy our performance obligation in September 2019. From inception through September 2018, we have included $145 million in total payments in the transaction price for our R&D services performance obligation. In the third quarter of 2018, we earned a $10 million milestone payment when Biogen initiated a Phase 1 study of IONIS-C9Rx. We recognized this milestone payment in full in the third quarter because we do not have any performance obligations related to this milestone payment. Additionally, we concluded that the payment is not related to our R&D services performance obligation. New antisense drugs for the treatment of SMA In December 2017, we entered into a collaboration agreement with Biogen to identify new antisense drugs for the treatment of SMA. Biogen will have the option to license therapies arising out of this collaboration following the completion of preclinical studies. Upon licensing, Biogen will be responsible for all further global development, regulatory and commercialization activities and costs for such therapies. Under the collaboration agreement, we received a $25 million upfront payment in December 2017. We will receive development and regulatory milestone payments from Biogen if new drugs advance towards marketing approval. In total over the term of our collaboration, we are eligible to receive up to $1.2 billion in license fees, milestone payments and other payments, including up to $80 million for the achievement of development milestones, up to $180 million for the achievement of commercialization milestones and up to $800 million for the achievement of sales milestones. In addition, we are eligible to receive tiered royalties from the mid-teens to mid-20 percent range on net sales. We will achieve the next payment of up to $60 millionfor the license of a drug under this collaboration. At the commencement of this collaboration, we identified one performance obligation, which was to perform R&D services for Biogen. We determined the transaction price to be the $25 million upfront payment we received when we entered into the collaboration. We allocated the transaction price to our single performance obligation. We are recognizing revenue for our R&D services performance obligation as we perform services based on our effort to satisfy our performance obligation relative to our total effort expected to satisfy our performance obligation. We currently estimate we will satisfy our performance obligation in December 2020. 2018 Strategic Neurology Collaboration In April 2018, we and Biogen entered into a new strategic collaboration to develop novel antisense drugs for a broad range of neurological diseases and entered into a SPA. As part of the collaboration, Biogen gained exclusive rights to the use of our antisense technology to develop therapies for these diseases for 10 years. We are responsible for the identification of antisense drug candidates based on selected targets, while Biogen will have the option to license therapies arising out of this collaboration and will be responsible for and pay for non-clinical studies, clinical development, manufacturing, and commercialization. In the second quarter of 2018, we received $1 billion from Biogen, comprised of $625 million to purchase our stock at a 25 percent cash premium and $375 million in an upfront payment. We are eligible to receive up to $270 million for each drug that achieves marketing approval. In addition, we are eligible to receive tiered royalties up to the 20 percent range on net sales. We will achieve the next payment of $7.5 million if Biogen designates a target under this collaboration. At the commencement of this collaboration, we identified one performance obligation, which was to perform R&D services for Biogen. We determined our transaction price to be $552 million, comprised of $375 million from the upfront payment and $177 million for the premium paid by Biogen for its purchase of our common stock. We determined the fair value of the premium we received by using the stated premium in the SPA and applying a lack of marketability discount. We included a lack of marketability discount in our valuation of the premium because Biogen received restricted shares. We allocated the transaction price to our single performance obligation. We are recognizing revenue for our R&D services performance obligation as we perform services based on our effort to satisfy our performance obligation relative to our total effort expected to satisfy our performance obligation. We currently estimate we will satisfy our performance obligation in June 2028. During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with Biogen (in millions, except percentage amounts):
Our condensed consolidated balance sheet at September 30, 2018 and December 31, 2017 included deferred revenue of $593.6 million and $93.6 million, respectively, related to our relationship with Biogen. Research, Development and Commercialization Partners AstraZeneca Cardiac, Renal and Metabolic Diseases Collaboration In July 2015, we and AstraZeneca formed a collaboration to discover and develop antisense therapies for treating cardiac, renal and metabolic diseases. Under our collaboration AstraZeneca has licensed three drugs from us. As part of the agreement, we granted AstraZeneca an exclusive license to IONIS-AZ4-2.5-LRx, a drug we designed to treat cardiovascular disease and our first drug that combines our Generation 2.5 and LIgand-Conjugated Antisense, or LICA, technology. We also granted AstraZeneca the option to license a drug for each additional target advanced under this research collaboration. In February 2018, AstraZeneca licensed a second drug under our collaboration, IONIS-AZ5-2.5Rx, a drug we designed to treat a genetically associated form of kidney disease. In March 2018, AstraZeneca licensed a third drug under our collaboration, IONIS-AZ6-2.5-LRx, a drug we designed to inhibit an undisclosed target to treat patients with nonalcoholic steatohepatitis, or NASH. AstraZeneca is responsible for all further global development, regulatory and commercialization activities and costs for IONIS-AZ4-2.5-LRx, IONIS-AZ5-2.5Rx and IONIS-AZ6-2.5-LRx and any other future drugs AstraZeneca licenses. Under the terms of the agreement, we received a $65 million upfront payment. We are eligible to receive license fees and milestone payments of up to more than $4 billion as drugs under this collaboration advance, including up to $1.1 billion for the achievement of development milestones and up to $2.9 billion for regulatory milestones. In addition, we are eligible to receive tiered royalties up to the low teens on sales from any product that AstraZeneca successfully commercializes under this collaboration agreement. From inception through September 2018, we have received over $165 million in upfront fees, license fees, milestone payments, and other payments under this collaboration, including a $10 million milestone payment we earned in the third quarter of 2018 when AstraZeneca initiated a Phase 1 trial for IONIS-AZ4-2.5-LRx. We will achieve the next payment of $10 million under this collaboration if we advance a drug under this collaboration. At the commencement of this collaboration, we identified one performance obligation, which was to perform R&D services for AstraZeneca. We determined the transaction price to be the $65 million upfront payment we received and we allocated it to our single performance obligation. We are recognizing revenue for our R&D services performance obligation as we perform services based on our effort to satisfy this performance obligation relative to our total effort expected to satisfy our performance obligation. We currently estimate we will satisfy this performance obligation in August 2021. As we achieve milestone payments for our R&D services, we include these amounts in our transaction price for our R&D services performance obligation. From inception through September 2018, we have included $90 million in payments in the transaction price for our R&D services performance obligation. We identified separate performance obligations upon AstraZeneca’s license of IONIS-AZ5-2.5Rx and IONIS-AZ6-2.5-LRx in the first quarter of 2018 because the licenses are distinct from our other performance obligation and each other. We recognized each $30 million license fee in the first quarter of 2018 because AstraZeneca had full use of the licenses without any continuing involvement from us. Additionally, we did not have any further performance obligations related to the licenses after we delivered them to AstraZeneca. In the third quarter of 2018, we earned a $10 million milestone payment when AstraZeneca initiated a Phase 1 study of IONIS-AZ4-2.5-LRx. We recognized this milestone payment in full in the third quarter because we do not have any performance obligations related to this milestone payment. Additionally, we concluded that the payment is not related to our R&D services performance obligation. Oncology Collaboration In December 2012, we entered into a collaboration agreement with AstraZeneca to discover and develop antisense drugs to treat cancer. As part of the agreement, we granted AstraZeneca an exclusive license to develop and commercialize danvatirsen (formerly IONIS-STAT3-2.5Rx) for the treatment of cancer. AstraZeneca is now responsible for all global development, regulatory and commercialization activities for danvatirsen. We and AstraZeneca have evaluated danvatirsen in people with head and neck cancer, advanced lymphoma and advanced metastatic hepatocellular carcinoma. AstraZeneca is evaluating danvatirsen in combination with Imfinzi (durvalumab), AstraZeneca’s programmed death ligand, or PD-L1, blocking drug, in people with head and neck cancer, metastatic bladder cancer and metastatic non-small cell lung cancer. In addition, we and AstraZeneca established an oncology research program. AstraZeneca has the option to license drugs resulting from the program, and if AstraZeneca exercises its option for a drug, it will be responsible for all further global development, regulatory and commercialization activities and costs for such drug. Under the terms of this agreement, we received $31 million in upfront payments. We are eligible to receive milestone payments and license fees from AstraZeneca as programs advance in development. If AstraZeneca successfully develops danvatirsen and another drug under the research program, we could receive license fees and milestone payments of up to more than $450 million, including up to $152 million for the achievement of development milestones and up to $275 million for the achievement of regulatory milestones. In addition, we are eligible to receive tiered royalties up to the low to mid-teens on sales from any drugs resulting from these programs. From inception through September 2018, we have received $97.8 million in upfront fees, milestone payments, and other payments under this oncology collaboration, not including nearly $30 million in milestone payments we achieved when AstraZeneca advanced two programs in the fourth quarter of 2018. We will achieve the next payment of up to $25.0 million if we advance a drug under our cancer research program with AstraZeneca. At the commencement of this collaboration, we identified four performance obligations. We determined the transaction price to be the $31 million in upfront payments we received. We allocated the transaction price based on the estimated stand-alone selling price of each of our performance obligations and recognized the associated revenue over the period of our performance. We recognized revenue for three of our obligations over our period of performance, concluding in March 2014. Our remaining performance obligation was to perform R&D services. We allocated $7.6 million to this performance obligation and recognized the associated revenue over the period of our performance, which ended in February 2018. As we achieved milestone payments for our R&D services, we included these amounts in our transaction price for our R&D services performance obligation. During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with AstraZeneca (in millions, except percentage amounts):
Our condensed consolidated balance sheet at September 30, 2018 and December 31, 2017 included deferred revenue of $44.9 million and $57.7 million, respectively, related to our relationship with AstraZeneca. Bayer In May 2015, we entered into an exclusive license agreement with Bayer to develop and commercialize IONIS-FXIRx for the prevention of thrombosis. We were responsible for completing a Phase 2 study of IONIS-FXIRx in people with end-stage renal disease on hemodialysis. Under the terms of the agreement, we received a $100 million upfront payment in the second quarter of 2015. In February 2017, we amended our agreement with Bayer to advance IONIS-FXIRx and to initiate development of IONIS-FXI-LRx, which Bayer licensed. In conjunction with the decision to advance these programs, we received a $75 million payment from Bayer. We are conducting a Phase 2b study evaluating IONIS-FXIRx in people with end-stage renal disease on hemodialysis to finalize dose selection. Additionally, we plan to develop IONIS-FXI-LRx through Phase 1. Following these studies and Bayer's decision to further advance these programs, Bayer will be responsible for all global development, regulatory and commercialization activities and costs for both drugs. We are eligible to receive additional milestone payments as each drug advances toward the market. In total over the term of this collaboration, we are eligible to receive up to $385 million in license fees, milestone payments and other payments, including up to $125 million for the achievement of development milestones and up to $110 million for the achievement of commercialization milestones. In addition, we are eligible to receive tiered royalties in the low to high 20 percent range on gross margins of both drugs combined. From inception through September 2018, we have received over $175 million from our Bayer collaboration. We will achieve the next payment of $10 million if a program advances under this collaboration. At the commencement of this collaboration, we identified three performance obligations. We determined the transaction price to be the $100 million in upfront payment we received. We allocated the transaction price based on the relative stand-alone selling prices of each of our performance obligations and recognized the associated revenue as follows:
In February 2017, when we amended our collaboration with Bayer, we identified two new performance obligations, one for the license of IONIS-FXI-LRx and one for R&D services. We determined the transaction price to be the $75 million payment. We allocated $64.9 million to the license of IONIS-FXI-LRx based on its estimated stand-alone selling price and recognized the associated revenue upon our delivery of the license in the first quarter of 2017. We allocated $10.1 million to our R&D services performance obligation based on an estimated stand-alone selling price. We are recognizing revenue for our R&D services performance obligation as we perform services based on our effort to satisfy our performance obligation relative to our total effort expected to satisfy our performance obligation. We currently estimate we will satisfy our R&D services performance obligation in May 2019. During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with Bayer (in millions, except percentage amounts):
Our condensed consolidated balance sheet at September 30, 2018 and December 31, 2017 included deferred revenue of $6.0 million and $9.3 million, respectively, related to our relationship with Bayer. Janssen Biotech, Inc. In December 2014, we entered into a collaboration agreement with Janssen Biotech, Inc. to discover and develop antisense drugs that can be locally administered, including oral delivery, to treat autoimmune disorders of the gastrointestinal tract. Janssen has the option to license drugs from us through the designation of a development candidate for up to three programs. Prior to option exercise we are responsible for the discovery activities to identify a development candidate. If Janssen exercises an option for one of the programs, it will be responsible for the global development, regulatory and commercial activities under that program. Under the terms of the agreement, we received $35 million in upfront payments. We are eligible to receive up to more than $800 million in license fees and milestone payments for these programs, including up to $175 million for the achievement of development milestones, up to $440 million for the achievement of regulatory milestones and up to $180 million for the achievement of commercialization milestones. From inception through September 2018, we have received $75 million, including $15 million in license fees when Janssen licensed IONIS-JBI1-2.5Rx and IONIS-JBI2-2.5Rx from us in 2016 and 2017, respectively. We also received $5 million in January 2018 for the initiation of a Phase 1 study of IONIS-JBI1-2.5Rx in late 2017. In addition, we are eligible to receive tiered royalties up to the near teens on sales from any drugs resulting from this collaboration. We will achieve the next payment of $5 million if Janssen continues to advance a target under this collaboration. At the commencement of this collaboration, we identified one performance obligation, which was to perform R&D services for Janssen. We determined the transaction price to be the $35 million upfront payments we received. We allocated the $35 million to our single performance obligation. As we achieved milestone payments for our R&D services, we included these amounts in our transaction price for our R&D services performance obligation. We recognized revenue for our R&D services performance obligation over our period of performance, through November 2017. We identified separate performance obligations each time Janssen licensed one of our drugs under our collaboration because the licenses we granted to Janssen were distinct from our other performance obligations. We recognized the $10 million license fee for IONIS-JBI1-2.5Rx in July 2016 and $5 million for the license of IONIS-JBI2-2.5Rx in November 2017, because Janssen had full use of the licenses without any continuing involvement from us. Additionally, we did not have any further performance obligations related to the licenses after we delivered them to Janssen. During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with Janssen (in millions, except percentage amounts):
We did not have any deferred revenue from our relationship with Janssen at September 30, 2018 or December 31, 2017. Roche Huntington's Disease In April 2013, we formed an alliance with Hoffman-La Roche Inc. and F. Hoffmann-La Roche Ltd., collectively Roche, to develop treatments for Huntington's disease, or HD, based on our antisense technology. Roche had the option to license the drugs from us through the completion of the first Phase 1 trial. Under the agreement, we are responsible for the discovery and development of an antisense drug targeting huntingtin, or HTT, protein. We evaluated a drug targeting HTT, IONIS-HTTRx, in a Phase 1/2a clinical study in people with early stage HD. In December 2017, upon completion of the Phase 1/2a study, Roche exercised its option to license IONIS-HTTRx and is now responsible for the global development, regulatory and commercialization activities for IONIS-HTTRx. Under the terms of the agreement, we received an upfront payment of $30 million in April 2013. In December 2016, we updated development activities for IONIS-HTTRx and as a result we were eligible for an additional $3 million payment, which we achieved in 2017. We are eligible to receive up to $365 million in a license fee and milestone payments including up to $70 million for the achievement of development milestones, up to $170 million for the achievement of regulatory milestones and up to $80 million for the achievement of commercialization milestones. In addition, we are eligible to receive up to $136.5 million in milestone payments for each additional drug successfully developed. We are also eligible to receive tiered royalties up to the mid-teens on any sales of any product resulting from this alliance. From inception through September 2018, we have received over $110 million in upfront fees, milestone payments and license fees for advancing IONIS-HTTRx, including the $45 million license fee we received in January 2018 for IONIS-HTTRx. We will achieve the next payment of $35 million if Roche initiates a pivotal study for IONIS-HTTRx. At the commencement of this collaboration, we identified one performance obligation, which was to perform R&D services for Roche. We determined the transaction price to be the $30 million upfront payment we received and allocated it to our single performance obligation. As we achieved milestone payments for our R&D services, we included these amounts in our transaction price for our R&D services performance obligation. We recognized revenue for our R&D services performance obligation over our period of performance, through September 2017. We identified a second performance obligation upon Roche’s license of IONIS-HTTRx in the fourth quarter of 2017 because the license we granted to Roche is distinct from our other performance obligation. We recognized the $45 million license fee for IONIS-HTTRx as revenue at that time because Roche had full use of the license without any continuing involvement from us. Additionally, we did not have any further performance obligations related to the license after we delivered it to Roche. We do not have any remaining performance obligations related to IONIS-HTTRx under this collaboration with Roche, however we can still earn additional payments and royalties as Roche advances IONIS-HTTRx. IONIS-FB-LRx for Complement-Mediated Diseases In October 2018, we entered into a collaboration agreement with Roche to develop IONIS-FB-LRx for the treatment of complement-mediated diseases. The first indication we plan to pursue is the treatment of patients with Geographic Atrophy, or GA, the advanced stage of dry age-related macular degeneration, or AMD. We are responsible for conducting a Phase 2 study in patients with dry AMD. In addition, we are exploring the drug in a severe and rare renal indication. Roche has the option to license IONIS-FB-LRx at the completion of these studies. Upon licensing, Roche will be responsible for all further global development, regulatory and commercialization activities and costs. Under this new collaboration agreement, we received a $75 million upfront payment in October 2018. We are eligible to receive up to $684 million in development, regulatory and sales milestone payments and license fees. In addition, we are also eligible to receive tiered royalties from the high teens to twenty percent on net sales. We will achieve the next payment of $20 million when we advance the Phase 2 study in patients with dry AMD. During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with Roche (in millions, except percentage amounts):
We did not have any deferred revenue from our relationship with Roche at September 30, 2018 or December 31, 2017. GSK In March 2010, we entered into an alliance with GSK using our antisense drug discovery platform to discover and develop new drugs against targets for rare and serious diseases, including infectious diseases and some conditions causing blindness. Under the terms of the agreement, we received upfront payments of $35 million. GSK is advancing two drugs targeting hepatitis B virus, or HBV, under our collaboration: IONIS-HBVRx and IONIS-HBV-LRx. GSK is currently conducting Phase 2 studies for both of these drugs, which we designed to reduce the production of viral proteins associated with HBV infection. In March 2016, we and GSK amended the development plan for IONIS-HBVRx to allow GSK to conduct all further development activities for this program. GSK has the exclusive option to license the drugs resulting from this alliance at Phase 2 proof-of-concept for a license fee. Under our agreement, if GSK successfully develops these drugs and achieves pre-agreed sales targets, we could receive license fees and milestone payments of $262 million, including up to $47.5 million for the achievement of development milestones, up to $120 million for the achievement of regulatory milestones and up to $70 million for the achievement of commercialization milestones. In addition, we are eligible to receive tiered royalties up to the mid-teens on sales from any product that GSK successfully commercializes under this alliance. From inception through September 2018, we have received more than $162 million in payments under this alliance with GSK. We will achieve the next payment of up to $25 million if GSK licenses a drug under this program. At the commencement of this collaboration, we identified one performance obligation, which was to perform R&D services for GSK. We determined the transaction price to be the $35 million upfront payment we received and allocated it to our single performance obligation. As we achieved milestone payments for our R&D services, we included these amounts in our transaction price for our R&D services performance obligation. We recognized revenue for our R&D services performance obligation over our period of performance, through March 2015. We do not have any remaining performance obligations under our collaboration with GSK, however we can still earn additional payments and royalties as GSK advances these drugs. During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with GSK (in millions, except percentage amounts):
Our revenue for the nine months ended September 30, 2017, was from our work on the programs under our collaboration with GSK. We did not have any deferred revenue from our relationship with GSK at September 30, 2018 or December 31, 2017. Akcea Collaborations The following collaboration agreements relate to Akcea, our majority owned affiliate. Our consolidated results include all the revenue earned and cash received under these collaboration agreements. We reflect the noncontrolling interest attributable to other owners of Akcea’s common stock in a separate line on the statement of operations and a separate line within stockholders’ equity in our condensed consolidated balance sheet. Novartis In January 2017, we and Akcea initiated a collaboration with Novartis to develop and commercialize AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx. Under the collaboration agreement, Novartis has an exclusive option to further develop and commercialize AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx. Akcea is responsible for completing a Phase 2 program, conducting an end-of-Phase 2 meeting with the FDA and providing initial quantities of API for each drug. If Novartis exercises an option for one of these drugs, Novartis will be responsible for all further global development, regulatory and co-commercialization activities and costs for such drug. Akcea received a $75 million upfront payment in the first quarter of 2017, of which it retained $60 million and paid us $15 million as a sublicense fee. If Novartis exercises its option for a drug, Novartis will pay Akcea a license fee equal to $150 million for each drug it licenses. In addition, for AKCEA-APO(a)-LRx, Akcea is eligible to receive up to $600 million in milestone payments, including $25 million for the achievement of a development milestone, up to $290 million for the achievement of regulatory milestones and up to $285 million for the achievement of commercialization milestones. In addition, for AKCEA-APOCIII-LRx, Akcea is eligible to receive up to $530 million in milestone payments, including $25 million for the achievement of a development milestone, up to $240 million for the achievement of regulatory milestones and up to $265 million for the achievement of commercialization milestones. Akcea is also eligible to receive tiered royalties in the mid-teens to low 20 percent range on net sales of AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx. Novartis will reduce these royalties upon the expiration of certain patents or if a generic competitor negatively impacts the product in a specific country. Akcea will pay 50 percent of these license fees, milestone payments and royalties to us as a sublicense fee. Akcea plans to co-commercialize any licensed drug commercialized by Novartis in selected markets under terms and conditions that we plan to negotiate with Novartis in the future, through its specialized sales force. In conjunction with this collaboration, we and Akcea entered into a SPA with Novartis. As part of the SPA, Novartis purchased 1.6 million shares of our common stock for $100 million in the first quarter of 2017. As part of the SPA, Novartis was required to purchase $50 million of Akcea’s common stock at the IPO price or our common stock at a premium if an IPO did not occur by April 2018. Under the SPA, in July 2017, Novartis purchased $50 million of Akcea’s common stock in a separate private placement concurrent with the completion of its IPO at a price per share equal to the IPO price. At the commencement of this collaboration, we identified four separate performance obligations:
We determined that the R&D services for each drug and the API for each drug were distinct from our other performance obligations. We determined our transaction price to be $108.4 million, comprised of the following:
We allocated the transaction price based on the estimated stand-alone selling price of each performance obligation as follows:
We are recognizing revenue related to the R&D services for the AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx performance obligations as we perform services based on our effort to satisfy our performance obligation relative to our total effort expected to satisfy our performance obligation. We currently estimate we will satisfy the significant portion of our performance obligation for AKCEA-APO(a)-LRx by December 2018 with the remainder by the end of March 2019. We currently estimate we will satisfy the significant portion of our performance obligation for AKCEA-APOCIII-LRx by June 2019 with the remainder by the end of December 2019. We recognized the amount attributed to the API supply for AKCEA-APO(a)-LRx when we delivered it to Novartis in 2017. We recognized the amount attributed to the API supply for AKCEA-APOCIII-LRx when we delivered it to Novartis in May 2018. Akcea is responsible for the development activities under this collaboration. As such, Akcea is recognizing the associated revenue in its statement of operations, and we reflect all of Akcea’s revenue in our consolidated results. Akcea pays us sublicense fees for payments that it receives under the collaboration and we recognize those fees as revenue in our Ionis Core operating segment results and Akcea recognizes the fees as R&D expense. In our consolidated results, we eliminate this sublicense revenue and expense. Any cash Akcea receives is included in our consolidated balance sheet. During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with Novartis (in millions, except percentage amounts):
Our condensed consolidated balance sheet at September 30, 2018 and December 31, 2017 included deferred revenue of $34.8 million and $70.7 million, respectively, related to our relationship with Novartis. PTC Therapeutics In August 2018, Akcea entered into an exclusive license agreement with PTC Therapeutics to commercialize TEGSEDI and WAYLIVRA in Latin America. Under the license agreement, Akcea will receive up to $26 million of payments, including $12 million which it received in the third quarter of 2018, $6 million upon the earlier of FDA or EMA approval of WAYLIVRA and up to $8 million of regulatory milestone payments. Akcea will receive royalties from PTC in the mid-20 percent range on net sales in Latin America for each drug. PTC's obligation to pay Akcea royalties begins on the earlier of 12 months after the first commercial sale of a product in Brazil or the date that PTC recognizes revenue of at least $10 million in Latin America. These royalties may be reduced upon expiration of certain patents or if a generic competitor negatively impacts PTC’s market share. Consistent with the agreements between Ionis and Akcea, the companies will share all payments, including royalties. At the commencement of this collaboration, we identified two performance obligations, which were the licenses Akcea granted to PTC to commercialize TEGSEDI and WAYLIVRA in Latin America in the third quarter of 2018. Akcea recognized $12 million in license fee revenue at that time because PTC had full use of both licenses without any continuing involvement from Akcea. Akcea does not have any remaining performance obligations under its collaboration with PTC. Akcea can still earn additional payments and royalties as PTC commercializes the drugs. Akcea is responsible for the activities under this collaboration. As such, Akcea is recognizing the associated revenue in its statement of operations, and we reflect all of Akcea’s revenue in our consolidated results. Akcea pays us sublicense fees for payments that it receives under the collaboration and we recognize those fees as revenue in our Ionis Core operating segment results and Akcea recognizes the fees as SG&A expense. For example, during the third quarter of 2018, we recognized $7.2 million of sublicense revenue in our Ionis Core operating segment results related to our portion of the PTC license fee Akcea paid us. In our consolidated results, we eliminate this sublicense revenue and expense. Any cash Akcea receives is included in our consolidated balance sheet. During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with PTC (in millions, except percentage amounts):
Our condensed consolidated balance sheet at September 30, 2018 and December 31, 2017 did not include any deferred revenue related to our relationship with PTC. |
Segment Information and Concentration of Business Risk |
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Segment Information and Concentration of Business Risk | 7. Segment Information and Concentration of Business Risk We have two reportable segments Ionis Core and Akcea Therapeutics. At September 30, 2018 we owned approximately 75 percent of Akcea. In October 2018, we received an additional 1.7 million shares of Akcea’s stock when TEGSEDI was approved by the FDA, increasing our ownership percentage to 76 percent. Segment income (loss) from operations includes revenue less operating expenses attributable to each segment. In our Ionis Core segment we are exploiting our antisense technology to generate a broad pipeline of first-in-class and/or best-in-class drugs for us and our partners. Our Ionis Core segment generates revenue from a multifaceted partnering strategy. Akcea is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with rare and serious diseases. The following tables show our segment revenue and income (loss) from operations for the three and nine months ended September 30, 2018 and 2017 (in thousands), respectively.
The following table shows our total assets by segment at September 30, 2018 and December 31, 2017 (in thousands), respectively.
We have historically funded our operations from collaborations with corporate partners and a relatively small number of partners have accounted for a significant percentage of our revenue. Revenue from significant partners, which is defined as ten percent or more of our total revenue, was as follows:
Contracts receivables from two significant partners comprised approximately 84 percent of our contracts receivables at September 30, 2018 and December 31, 2017. |
Basis of Presentation (Policies) |
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Basis of Presentation [Abstract] | |
Basis of Presentation | We prepared the unaudited interim condensed consolidated financial statements for the three and nine months ended September 30, 2018 and 2017 on the same basis as the audited financial statements for the year ended December 31, 2017. We included all normal recurring adjustments in the financial statements, which we considered necessary for a fair presentation of our financial position at such dates and our operating results and cash flows for those periods. Results for the interim periods are not necessarily indicative of the results for the entire year. For more complete financial information, these financial statements, and notes thereto, should be read in conjunction with the audited financial statements for the year ended December 31, 2017 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC. |
Consolidation | In the condensed consolidated financial statements, we included the accounts of Ionis Pharmaceuticals, Inc. and the consolidated results of our majority owned affiliate, Akcea Therapeutics, Inc. and its wholly owned subsidiaries, which we formed in December 2014. Prior to Akcea’s initial public offering, or IPO, in July 2017, we owned 100 percent of Akcea. From the closing of Akcea’s IPO in July 2017 through mid-April 2018, we owned approximately 68 percent of Akcea. In the second and third quarters of 2018, we received additional shares of Akcea’s stock related to our license of TEGSEDI and AKCEA-TTR-LRx to Akcea, increasing our ownership percentage to approximately 75 percent. We reflected the increase in our ownership in these financial statements. In October 2018, we received an additional 1.7 million shares of Akcea’s stock when TEGSEDI received marketing authorization in the U.S., increasing our ownership to approximately 76 percent. Refer to the section titled “Noncontrolling Interest in Akcea” in Note 2, Significant Accounting Policies, for further information related to our accounting for our investment in Akcea. |
Significant Accounting Policies (Policies) |
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Revenue Recognition | Revenue Recognition Adoption of New Revenue Recognition Accounting Standard (Topic 606) In May 2014, the FASB issued accounting guidance on the recognition of revenue from customers. This guidance supersedes the revenue recognition requirements we previously followed in Accounting Standards Codification, or ASC, Topic 605, Revenue Recognition, or Topic 605, and created a new Topic 606, Revenue from Contracts with Customers, or Topic 606. Under Topic 606, an entity will recognize revenue when it transfers control of promised goods or services to customers in an amount that reflects what the entity expects to receive in exchange for the goods or services. Further, an entity will recognize revenue upon satisfying the performance obligation(s) under the related contract. We adopted Topic 606 on January 1, 2018 under the full retrospective approach, which required us to revise our prior period revenue. Under Topic 606, we were required to review all of our ongoing collaboration agreements in which we recognized revenue after January 1, 2016. We were required to assess what our revenue would have been for the period from January 1, 2016 to December 31, 2017 under Topic 606. As a result of this analysis, we determined that the cumulative revenue we would have recognized under Topic 606 decreased by $53.6 million. We recorded this amount as a cumulative adjustment to our accumulated deficit as of December 31, 2017. We have labeled our prior period financial statements “as revised” to indicate the change required under the accounting rules. The following tables summarize the adjustments we were required to make to amounts we originally reported in 2017 to adopt Topic 606 (in thousands, except per share amounts): Condensed Consolidated Balance Sheet
Condensed Consolidated Statement of Operations
Condensed Consolidated Statement of Cash Flows
Under Topic 606, compared to Topic 605, our revenue decreased $2.6 million for the three months ended September 30, 2017, and increased $11.0 million for the nine months ended September 30, 2017. The change in our revenue was primarily due to:
Our updated revenue recognition policy reflecting Topic 606 is as follows: Our Revenue Sources We generally recognize revenue when we have satisfied all contractual obligations and are reasonably assured of collecting the resulting receivable. We are often entitled to bill our customers and receive payment from our customers in advance of recognizing the revenue. In the instances in which we have received payment from our customers in advance of recognizing revenue, we include the amounts in deferred revenue on our condensed consolidated balance sheet. Commercial Revenue: SPINRAZA royalties and Licensing and other royalty revenue We earn commercial revenue primarily in the form of royalty payments on net sales of SPINRAZA. We expect to add product sales from TEGSEDI to our commercial revenue in the fourth quarter of 2018 as a result of TEGSEDI’s approval in the U.S., EU and Canada. We will also recognize as commercial revenue future sales milestone payments and royalties we earn under our partnerships. Research and development revenue under collaborative agreements We often enter into collaboration agreements to license and sell our technology on an exclusive or non-exclusive basis. Our collaboration agreements typically contain multiple elements, or performance obligations, including technology licenses or options to obtain technology licenses, research and development, or R&D, services, and manufacturing services. Our collaboration agreements are detailed in Note 6, Collaborative Arrangements and Licensing Agreements. Under each collaboration note we discuss our specific revenue recognition conclusions, including our significant performance obligations under each collaboration. Steps to Recognize Revenue We use a five step process to determine the amount of revenue we should recognize and when we should recognize it. The five step process is as follows:
Accounting rules require us to first determine if we have a contract with our partner, including confirming that we have met each of the following criteria:
We next identify the distinct goods and services we are required to provide under the contract. Accounting rules refer to these as our performance obligations. We typically have only one performance obligation at the inception of a contract, which is to perform R&D services. Often times when we enter into a collaboration agreement in which we provide our partner with an option to license a drug in the future. We may also provide our partner with an option to request that we provide additional goods or services in the future, such as active pharmaceutical ingredient, or API. We evaluate whether these options are material rights at the inception of the agreement. If we determine an option is a material right, we will consider the option a separate performance obligation. Historically, we have concluded that the options we grant to license a drug in the future or to provide additional goods and services as requested by our partner are not material rights. These items are contingent upon future events that may not occur. When a partner exercises its option to license a drug or requests additional goods or services, then we identify a new performance obligation for that item. In some cases, we deliver a license at the start of an agreement. If we determine that our partner has full use of the license and we do not have any additional performance obligations related to the license after delivery, then we consider the license to be a separate performance obligation.
We then determine the transaction price by reviewing the amount of consideration we are eligible to earn under the collaboration agreement, including any variable consideration. Under our collaboration agreements, consideration typically includes fixed consideration in the form of an upfront payment and variable consideration in the form of potential milestone payments, license fees and royalties. At the start of an agreement, our transaction price usually consists of only the upfront payment. We do not typically include any payments we may receive in the future in our initial transaction price because the payments are not probable. We reassess the total transaction price at each reporting period to determine if we should include additional payments in the transaction price. Milestone payments are our most common type of variable consideration. We recognize milestone payments using the most likely amount method because we will either receive the milestone payment or we will not, which makes the potential milestone payment a binary event. The most likely amount method requires us to determine the likelihood of earning the milestone payment. We include a milestone payment in the transaction price once it is probable we will achieve the milestone event. Most often, we do not consider our milestone payments probable until we or our partner achieve the milestone event because the majority of our milestone payments are contingent upon events that are not within our control.
Next, we allocate the transaction price to each of our performance obligations. When we have to allocate the transaction price to more than one performance obligation, we make estimates of the relative stand-alone selling price of each performance obligation because we do not typically sell our goods or services on a stand-alone basis. We then allocate the transaction price to each performance obligation based on the relative stand-alone selling price. We may engage a third party, independent valuation specialist to assist us with determining a stand-alone selling price for collaborations in which we deliver a license at the start of an agreement. We estimate the stand-alone selling price of these licenses using valuation methodologies, such as the relief from royalty method. Under this method, we estimate the amount of income, net of taxes, for the license. We then discount the projected income to present value. The significant inputs we use to determine the projected income of a license could include:
We typically estimate the selling price of R&D services by using our internal estimates of the cost to perform the specific services. The significant inputs we use to determine the selling price of our R&D services include:
For purposes of determining the stand-alone selling price of the R&D services we perform and the API we will deliver, accounting guidance requires us to include a markup for a reasonable profit margin. We do not reallocate the transaction price after the start of an agreement to reflect subsequent changes in stand-alone selling prices.
We recognize revenue in one of two ways, over time or at a point in time. We recognize revenue over time when we are executing on our performance obligation over time and our partner receives benefit over time. For example, we recognize revenue over time when we provide R&D services. We recognize revenue at a point in time when our partner receives full use of an item at a specific point in time. For example, we recognize revenue at a point in time when we deliver a license or API to a partner. For R&D services that we recognize over time, we measure our progress using an input method. The input methods we use are based on the effort we expend or costs we incur toward the satisfaction of our performance obligation. We estimate the amount of effort we expend, including the time we estimate it will take us to complete the activities, or costs we incur in a given period, relative to the estimated total effort or costs to satisfy the performance obligation. This results in a percentage that we multiply by the transaction price to determine the amount of revenue we recognize each period. This approach requires us to make numerous estimates and use significant judgement. If our estimates or judgements change over the course of the collaboration, they may affect the timing and amount of revenue that we recognize in the current and future periods. The following are examples of when we typically recognize revenue based on the types of payments we receive. Commercial Revenue: SPINRAZA royalties and Licensing and other royalty revenue We recognize royalty revenue in the period in which the counterparty sells the related product, which in certain cases may require us to estimate our royalty revenue. We recognize royalties from SPINRAZA sales in the period Biogen records the sale of SPINRAZA. Our accounting for SPINRAZA royalties did not change as a result of adopting Topic 606. Research and development revenue under collaboration agreements: Upfront Payments When we enter into a collaboration agreement with an upfront payment, we typically record the entire upfront payment as deferred revenue if our only performance obligation is for R&D services we will provide in the future. We amortize the upfront payment into revenue as we perform the R&D services. For example, under our new SMA collaboration with Biogen, we received a $25 million upfront payment in December 2017. We allocated the upfront payment to our single performance obligation, R&D services. We are amortizing the $25 million upfront payment using an input method over the estimated period of time we are providing R&D services. Refer to Note 6, Collaborative Arrangements and Licensing Agreements, for further discussion. Under Topic 605, we amortized upfront payments evenly over the period of our obligation. Milestone Payments We typically include milestone payments for R&D services in the transaction price when they are achieved. We include these milestone payments when they are achieved because there is considerable uncertainty in the research and development processes that trigger these payments under our collaboration agreements. Similarly, we include approval milestone payments in the transaction price once the drug is approved by the applicable regulator. We will recognize sales based milestone payments in the period we achieve the milestone under the sales-based royalty exception allowed under accounting rules. We recognize milestone payments that relate to an ongoing performance obligation over our period of performance. For example, in the third quarter of 2017, we initiated a Phase 1/2a clinical study of IONIS-MAPTRx in patients with mild Alzheimer’s disease. We earned a $10 million milestone payment from Biogen related to the initiation of this study. Under Topic 606, we allocated this payment to our R&D services performance obligation. We are recognizing revenue from this milestone payment over our estimated period of performance. Under Topic 605, this milestone payment was recognized in full in the third quarter of 2017, which was the period in which we achieved the milestone event. Conversely, we recognize in full those milestone payments that we earn based on our partners’ activities when our partner achieves the milestone event. For example, in the third quarter of 2018, we earned a $10 million milestone payment when AstraZeneca initiated a Phase 1 study of IONIS-AZ4-2.5-LRx. Our revenue recognition of milestone payments we earn based on our partners’ activities did not change as a result of adopting Topic 606. License Fees We generally recognize as revenue the total amount we determine to be the stand-alone selling price of a license when we deliver the license to our partner. This is because our partner has full use of the license and we do not have any additional performance obligations related to the license after delivery. For example, in the third quarter of 2018, we earned a $12 million license fee when our majority-owned affiliate, Akcea, entered into an exclusive license agreement with PTC Therapeutics to commercialize TEGSEDI and WAYLIVRA in Latin America. Our recognition of license fees did not change as a result of adopting Topic 606. Amendments to Agreements From time to time we amend our collaboration agreements. When this occurs, we are required to assess the following items to determine the accounting for the amendment:
If we conclude the goods and/or services in the amendment are distinct from the performance obligations in the original agreement and at a stand-alone selling price, we account for the amendment as a separate agreement. If we conclude the goods and/or services are not distinct and at their standalone selling price, we then assess whether the remaining goods or services are distinct from those already provided. If the goods and/or services are distinct from what we have already provided, then we allocate the remaining transaction price from the original agreement and the additional transaction price from the amendment to the remaining goods and/or services. If the goods and/or services are not distinct from what we have already provided, we update the transaction price for our single performance obligation and recognize any change in our estimated revenue as a cumulative adjustment. For example, in May 2015, we entered into an exclusive license agreement with Bayer to develop and commercialize IONIS-FXIRx for the prevention of thrombosis. As part of the agreement, Bayer paid us a $100 million upfront payment. At the onset of the agreement, we were responsible for completing a Phase 2 study of IONIS-FXIRx in people with end-stage renal disease on hemodialysis and for providing an initial supply of API. In February 2017, we amended our agreement with Bayer to advance IONIS-FXIRx and to initiate development of IONIS-FXI-LRx, which Bayer licensed. As part of the 2017 amendment, Bayer paid us $75 million. We are also eligible to receive milestone payments and tiered royalties on gross margins of IONIS-FXIRx and IONIS-FXI-LRx. Under the 2017 amendment, we concluded we had a new agreement with three performance obligations. These performance obligations were to deliver the license of IONIS-FXI-LRx, to provide R&D services and to deliver API. We allocated the $75 million transaction price to these performance obligations. Refer to Note 6, Collaborative Arrangements and Licensing Agreements, for further discussion of our accounting treatment for our Bayer collaboration. Our allocation of the consideration we received for the Bayer amendment did not change as a result of adopting Topic 606. However, the method in which we are recognizing revenue related to our R&D services performance obligation did change. We are amortizing revenue related to our R&D services performance obligation using the input method under Topic 606. Multiple Agreements From time to time, we may enter into separate agreements at or near the same time with the same partner. We evaluate such agreements to determine whether we should account for them individually as distinct arrangements or whether the separate agreements should be combined and accounted for together. We evaluate the following to determine the accounting for the agreements:
Our evaluation involves significant judgment to determine whether a group of agreements might be so closely related that accounting guidance requires us to account for them as a combined arrangement. For example, in the second quarter of 2018, we entered into two separate agreements with Biogen at the same time: a new strategic neurology collaboration agreement and a stock purchase agreement, or SPA. We evaluated the Biogen agreements to determine whether we should treat the agreements separately or combine them. We considered that the agreements were negotiated concurrently and in contemplation of one another. Based on these facts and circumstances, we concluded that we should evaluate the provisions of the agreements on a combined basis. Refer to Note 6, Collaborative Arrangements and Licensing Agreements for further discussion of the accounting treatment for the 2018 strategic neurology collaboration with Biogen. Contracts Receivable Our contracts receivable balance represents the amounts we have billed our partners for goods we have delivered or services we have performed that are due to us unconditionally. When we bill our partners with payment terms based on the passage of time, we consider the contract receivable to be unconditional. We typically receive payment within one quarter of billing our partner. Our contracts receivable balance as of December 31, 2017 did not change when we adopted Topic 606. Unbilled SPINRAZA Royalties Our unbilled SPINRAZA royalties represent our right to receive consideration from Biogen in advance of when we are eligible to bill Biogen for SPINRAZA royalties. We include these unbilled amounts in other current assets on our condensed consolidated balance sheet. Our unbilled SPINRAZA royalties as of December 31, 2017 did not change when we adopted Topic 606. Deferred Revenue We are often entitled to bill our customers and receive payment from our customers in advance of our obligation to provide services or transfer goods to our partners. In these instances, we include the amounts in deferred revenue on our condensed consolidated balance sheet. During the three and nine months ended September 30, 2018, we recognized $37.2 million and $80.4 million of revenue from amounts that were in our beginning deferred revenue balances for those periods, respectively. During the three and nine months ended September 30, 2017, we recognized $31.6 million and $84.4 million of revenue from amounts that were in our beginning deferred revenue balances for those periods, respectively. Refer to our revenue recognition policy above detailing how we recognize revenue for further discussion. The following table summarizes the adjustments we were required to make to our deferred revenue amounts to adopt Topic 606 (in thousands):
Our deferred revenue balance increased $54.2 million at December 31, 2017 under Topic 606, compared to Topic 605. The increase was primarily related to the change in the accounting for certain milestone payments and the way in which we amortize payments. Under Topic 605, we previously recognized the majority of the milestone payments we earned in the period we achieved the milestone event, which did not impact our deferred revenue balance. Under Topic 606 we are now amortizing more milestone payments over the period of our performance obligation, which adds to our deferred revenue balance. Additionally, under Topic 605 we amortized payments evenly over the period of our obligation. Under Topic 606, we are required to use an input method to determine the amount we amortize each reporting period. The increase in deferred revenue relates to agreements with the following partners:
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Noncontrolling Interest in Akcea Therapeutics, Inc. | Noncontrolling Interest in Akcea Therapeutics, Inc. Prior to Akcea’s IPO in July 2017, we owned 100 percent of Akcea. From the closing of Akcea’s IPO in July 2017 through mid-April 2018, we owned approximately 68 percent of Akcea. In the second and third quarters of 2018, we received additional shares of Akcea’s stock related to our license of TEGSEDI and AKCEA-TTR-LRx to Akcea, increasing our ownership percentage to approximately 75 percent. We reflected this increase in our ownership percentage in these financial statements as an adjustment to noncontrolling interest. In October 2018, we received an additional 1.7 million shares of Akcea’s stock when TEGSEDI received marketing authorization in the U.S., increasing our ownership to approximately 76 percent. The shares third parties own represent an interest in Akcea’s equity that is not controlled by us. However, as we continue to maintain overall control of Akcea through our voting interest, we reflect the assets, liabilities and results of operations of Akcea in our consolidated financial statements. We reflect the noncontrolling interest attributable to other owners of Akcea’s common stock in a separate line on the statement of operations and a separate line within stockholders’ equity in our condensed consolidated balance sheet. In addition, we record a noncontrolling interest adjustment to account for the stock options Akcea grants, which if exercised, will dilute our ownership in Akcea. This adjustment is a reclassification within stockholders’ equity from additional paid-in capital to noncontrolling interest in Akcea equal to the amount of stock-based compensation expense Akcea had recognized. |
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Cash, Cash Equivalents and Investments | Cash, cash equivalents and investments We consider all liquid investments with maturities of three months or less when we purchase them to be cash equivalents. Our short-term investments have initial maturities of greater than three months from date of purchase. We classify our short-term debt investments as “available-for-sale” and carry them at fair market value based upon prices on the last day of the fiscal period for identical or similar items. We record unrealized gains and losses on debt securities as a separate component of comprehensive income (loss) and include net realized gains and losses in gain (loss) on investments. We use the specific identification method to determine the cost of securities sold. We also have equity investments of less than 20 percent ownership in publicly and privately held biotechnology companies that we received as part of a technology license or partner agreement. At September 30, 2018, we held an equity investment in one publicly held company, Antisense Therapeutics Limited, or ATL. We also held equity investments in four privately-held companies, Atlantic Pharmaceuticals Limited, Dynacure SAS, Seventh Sense Biosystems and Suzhou Ribo Life Science Co, Ltd. In January 2018, we adopted the amended accounting guidance related to the recognition, measurement, presentation, and disclosure of certain financial instruments. The amended guidance requires us to measure and record our equity investments at fair value. Additionally, the amended accounting guidance requires us to recognize the changes in fair value in our consolidated statement of operations, instead of through accumulated other comprehensive income. Prior to 2018, we accounted for our equity investments in privately held companies under the cost method of accounting. Under the amended guidance we account for our equity investments in privately held companies at their cost minus impairments, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer. Our adoption of this guidance did not have an impact on our results. |
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Inventory Valuation | Inventory valuation We reflect our inventory on our consolidated balance sheet at the lower of cost or market value under the first-in, first-out method, or FIFO. We capitalize the costs of raw materials that we purchase for use in producing our drugs because until we use these raw materials they have alternative future uses. We include in inventory raw material costs for drugs that we manufacture for our partners under contractual terms and that we use primarily in our clinical development activities and drug products. We can use each of our raw materials in multiple products and, as a result, each raw material has future economic value independent of the development status of any single drug. For example, if one of our drugs failed, we could use the raw materials for that drug to manufacture our other drugs. We expense these costs as R&D expenses when we begin to manufacture API for a particular drug if the drug has not been approved for marketing by a regulatory agency. We obtained the first regulatory approval for TEGSEDI in July 2018. At September 30, 2018 and December 31, 2017, our physical inventory for TEGSEDI included API that we produced prior to when we obtained regulatory approval and accordingly has no cost basis as we had previously expensed the costs as R&D expenses. We review our inventory periodically and reduce the carrying value of items we consider to be slow moving or obsolete to their estimated net realizable value based on forecasted demand compared to quantities on hand. We consider several factors in estimating the net realizable value, including shelf life of our inventory, alternative uses for our drugs and historical write-offs. We did not record any inventory write-offs for the nine months ended September 30, 2018 and 2017. |
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Research and Development Expenses | Research, development and patent expenses Our research and development expenses include wages, benefits, facilities, supplies, external services, clinical trial and manufacturing costs and other expenses that are directly related to our research and development operations. We expense research and development costs as we incur them. When we make payments for research and development services prior to the services being rendered, we record those amounts as prepaid assets on our condensed consolidated balance sheet and we expense them as the services are provided. We capitalize costs consisting principally of outside legal costs and filing fees related to obtaining patents. We amortize patent costs over the useful life of the patent, beginning with the date the United States Patent and Trademark Office, or foreign equivalent, issues the patent. We review our capitalized patent costs regularly to ensure that they include costs for patents and patent applications that have future value. We evaluate patents and patent applications that we are not actively pursuing and write off any associated costs. |
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Patent Expenses | We capitalize costs consisting principally of outside legal costs and filing fees related to obtaining patents. We amortize patent costs over the useful life of the patent, beginning with the date the United States Patent and Trademark Office, or foreign equivalent, issues the patent. We review our capitalized patent costs regularly to ensure that they include costs for patents and patent applications that have future value. We evaluate patents and patent applications that we are not actively pursuing and write off any associated costs. |
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Long-Lived Assets | Long-lived assets We evaluate long-lived assets, which include property, plant and equipment and patent costs acquired from third parties, for impairment on at least a quarterly basis and whenever events or changes in circumstances indicate that we may not be able to recover the carrying amount of such assets. |
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Use of Estimates | Use of estimates The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the amounts reported in our condensed consolidated financial statements and accompanying notes. Actual results could differ from those estimates. |
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Basic and Diluted Net Income (Loss) per Share | Basic and diluted net income (loss) per share Basic net income (loss) per share We compute basic net income (loss) per share by dividing the total net income (loss) attributable to our common stockholders by our weighted-average number of common shares outstanding during the period. The calculation of total net income (loss) attributable to our common stockholders for the three and nine months ended September 30, 2018 and 2017 considered our net income for Ionis on a stand-alone basis plus our share of Akcea’s net loss for the period. To calculate the portion of Akcea’s net loss attributable to our ownership, we multiplied Akcea’s loss per share by the weighted average shares we owned in Akcea during the period. As a result of this calculation, our total net income (loss) available to Ionis common stockholders for the calculation of net income (loss) per share is different than net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders in the condensed consolidated statements of operations. Our basic net loss per share for the three months ended September 30, 2018, was calculated as follows (in thousands, except per share amounts):
Akcea’s net loss per share calculation for the nine months ended September 30, 2018 included two components: (1) Akcea’s net loss from its statement of operations and (2) deemed distributions related to the license of TEGSEDI in the second quarter of 2018. Because we own more than 50 percent of Akcea, we and Akcea are under common control. As such, Akcea accounted for the TEGSEDI transaction using common control guidance. Accordingly, Akcea recorded the license we granted to them at carrying value. In addition, Akcea recorded the consideration it paid to us in excess of the carrying value as a deemed distribution. Accounting rules required Akcea to include these deemed distributions in their net loss per share calculation as if Akcea had paid us a dividend. Our basic net loss per share for the nine months ended September 30, 2018, was calculated as follows (in thousands, except per share amounts):
Prior to Akcea’s IPO in July 2017, we owned Akcea series A convertible preferred stock, which included a six percent cumulative dividend. Upon completion of Akcea’s IPO in July 2017, our preferred stock was converted into common stock on a 1:1 basis. The preferred stock dividend was not paid at the IPO because the IPO was not a liquidation event or a change in control. During the three and nine months ended September 30, 2017, Akcea used a two-class method to compute its net income (loss) per share because it had both common and preferred shares outstanding during the periods. The two-class method required Akcea to calculate its net income (loss) per share for each class of stock by dividing total distributable losses applicable to preferred and common stock, including the six percent cumulative dividend contractually due to series A convertible preferred shareholders, by the weighted-average of preferred and common shares outstanding during the requisite period. Since Akcea used the two-class method, accounting rules required us to include our portion of Akcea's net income (loss) per share for both Akcea's common and preferred shares that we owned in our calculation of basic and diluted net income (loss) per share for three and nine months ended September 30, 2017. Our basic net income per share for the three months ended September 30, 2017, was calculated as follows (in thousands, except per share amounts):
Our basic net income per share for the nine months ended September 30, 2017, was calculated as follows (in thousands, except per share amounts):
Dilutive net income (loss per share) For the three and nine months ended September 30, 2018 and for the three months ended September 30, 2017, we incurred a net loss; therefore, we did not include dilutive common equivalent shares in the computation of diluted net loss per share because the effect would have been anti-dilutive. Common stock from the following would have had an anti-dilutive effect on net loss per share:
For the nine months ended September 30, 2017, we had net income available to Ionis common stockholders. As a result, we computed diluted net income per share using the weighted-average number of common shares and dilutive common equivalent shares outstanding during those periods. Diluted common equivalent shares for the nine months ended September 30, 2017 consisted of the following (in thousands except per share amounts):
For the nine months ended September 30, 2017, the calculation excluded the 1 percent and 2¾ percent notes because the effect on diluted earnings per share was anti-dilutive. |
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Accumulated Other Comprehensive Loss | Accumulated other comprehensive loss We include unrealized gains and losses on investments, net of taxes, in accumulated other comprehensive income (loss) along with adjustments we make to reclassify realized gains and losses on investments from other accumulated comprehensive income (loss) to our condensed consolidated statement of operations. The following table summarizes changes in accumulated other comprehensive income (loss) for the three and nine months ended September 30, 2018 and 2017 (in thousands):
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Convertible Debt | Convertible debt We account for convertible debt instruments that may be settled in cash upon conversion (including partial cash settlement) by separating the liability and equity components of the instruments in a manner that reflects our nonconvertible debt borrowing rate. We determine the carrying amount of the liability component by measuring the fair value of similar debt instruments that do not have the conversion feature. If no similar debt instrument exists, we estimate fair value by using assumptions that market participants would use in pricing a debt instrument, including market interest rates, credit standing, yield curves and volatilities. To determine the fair value of the debt component we are required to use accounting estimates and assumptions. These estimates and assumptions are judgmental in nature and could have a significant impact on the determination of the debt component, and the associated non-cash interest expense. We assigned a value to the debt component of our convertible notes equal to the estimated fair value of similar debt instruments without the conversion feature, which resulted in us recording our debt at a discount. We are amortizing our debt issuance costs and debt discount over the life of the convertible notes as additional non-cash interest expense utilizing the effective interest method. |
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Segment Information | Segment information We have two operating segments, our Ionis Core segment and Akcea Therapeutics, our majority owned affiliate. Akcea is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with rare and serious diseases. We provide segment financial information and results for our Ionis Core segment and our Akcea Therapeutics segment based on the segregation of revenues and expenses that our chief decision maker reviews to assess operating performance and to make operating decisions. We allocate a portion of Ionis’ development, R&D support and general and administrative expenses to Akcea for work Ionis performs on behalf of Akcea. |
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Stock-Based Compensation Expense | Stock-based compensation expense We measure stock-based compensation expense for equity-classified awards, principally related to stock options, restricted stock units, or RSUs, and stock purchase rights under our ESPP, based on the estimated fair value of the award on the date of grant. We recognize the value of the portion of the award that we ultimately expect to vest as stock-based compensation expense over the requisite service period in our condensed consolidated statements of operations. We reduce stock-based compensation expense for estimated forfeitures at the time of grant and revise in subsequent periods if actual forfeitures differ from those estimates. We use the Black-Scholes model to estimate the fair value of stock options granted and stock purchase rights under our ESPP. The expected term of stock options granted represents the period of time that we expect them to be outstanding. We estimate the expected term of options granted based on historical exercise patterns. For the nine months ended September 30, 2018 and 2017, we used the following weighted-average assumptions in our Black-Scholes calculations: Employee Stock Options:
Board of Director Stock Options:
ESPP:
The fair value of RSUs is based on the market price of our common stock on the date of grant. RSUs vest annually over a four-year period. The weighted-average grant date fair value of RSUs granted to employees and members of our board of directors for the nine months ended September 30, 2018 was $51.83 and $42.88 per share, respectively. The following table summarizes stock-based compensation expense for the three and nine months ended September 30, 2018 and 2017 (in thousands). Our consolidated non-cash stock-based compensation expense includes $12.7 million and $4.7 million of stock-based compensation expense for Akcea for the three months ended September 30, 2018 and 2017, respectively, and $31.2 million and $11.8 million for the nine months ended September 30, 2018 and 2017, respectively.
As of September 30, 2018, total unrecognized estimated non-cash stock-based compensation expense related to non-vested stock options and RSUs was $139.5 million and $32.6 million, respectively. We will adjust total unrecognized compensation cost for future forfeitures. We expect to recognize the cost of non-cash stock-based compensation expense related to non-vested stock options and RSUs over a weighted average amortization period of 1.3 years and 1.6 years, respectively. |
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Impact of Recently Issued Accounting Standards | Impact of recently issued accounting standards In February 2016, the FASB issued amended accounting guidance related to lease accounting, which will require us to record all leases with a term longer than one year on our balance sheet. When we record leases on our balance sheet under the new guidance, we will record a liability with a value equal to the present value of payments we will make over the life of the lease and an asset representing the underlying leased asset. The new accounting guidance requires us to determine if our leases are operating or financing leases. We will record expense for operating leases on a straight-line basis as an operating expense. If we determine a lease is a financing lease, we will record both interest and amortization expense and generally the expense will be higher in the earlier periods of the lease. The new lease standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted. We will adopt this guidance on January 1, 2019. We can choose from two methods of adoption. The first method requires us to reflect our leases on our balance sheet in the earliest comparative period presented in our financial statements. The second method requires us to reflect the impact of adoption on the date we adopt the new guidance and recognize a cumulative-effect adjustment to the opening balance of our accumulated deficit in that period. We are currently determining the method we will use to adopt the new guidance and assessing the effects the new guidance will have on our consolidated financial statements and disclosures. In June 2016, the FASB issued guidance that changes the measurement of credit losses for most financial assets and certain other instruments. If we have credit losses, this updated guidance requires us to record allowances for these instruments under a new expected credit loss model. This model requires us to estimate the expected credit loss of an instrument over its lifetime, which represents the portion of the amortized cost basis we do not expect to collect. The new guidance requires us to remeasure our allowance in each reporting period we have credit losses. The new standard is effective for annual and interim periods beginning after December 15, 2019. Early adoption is permitted for periods beginning after December 15, 2018. When we adopt the new standard, we will make any adjustments to beginning balances through a cumulative-effect adjustment to accumulated deficit on that date. We plan to adopt this guidance on January 1, 2020. We are currently assessing the effects it will have on our consolidated financial statements and disclosures. In December 2017, the SEC staff issued guidance to address how companies should account for the Tax Act of 2017, or the Tax Act, when an entity does not have the necessary information to complete the accounting for the Tax Act and gives entities up to one year from the enactment of the Tax Act to finalize their amounts. We recognized provisional amounts in our 2017 financial statements and in these financial statements. The ultimate impact may differ materially from these provisional amounts due to, among other things, additional analysis, changes in our interpretations and assumptions, additional regulatory guidance that may be issued, and other actions we may take resulting from the Tax Act. We will assess and update our provisional amounts and disclosures, as necessary, at year end 2018. In February 2018, the FASB issued updated guidance for reclassification of tax effects from accumulated other comprehensive income (loss). The updated guidance gives entities an option to reclassify amounts included in accumulated other comprehensive income (loss) that under the Tax Act do not have a way to be relieved, and allows a one-time reclassification to retained earnings. The updated guidance is effective for all entities for fiscal years beginning after December 31, 2018, and interim periods within those fiscal years. Early adoption is permitted, and adoption is optional. We are currently assessing the effects this updated guidance could have on our consolidated financial statements and timing of potential adoption. In June 2018, the FASB issued updated guidance to simplify the accounting for stock-based compensation expense for nonemployees. Specifically, we are now expensing grants to nonemployees in a similar manner as grants to employees and our Board of Directors. Previously, we had to re-value these grants at each reporting period to reflect the current fair value. Under the amended guidance, we value grants to nonemployees when we grant them and we will not adjust their value for future changes. We adopted this guidance in the second quarter of 2018 on a prospective basis. The updated guidance did not have a material impact to our financial results. In August 2018, the FASB issued clarifying guidance on how to account for implementation costs related to cloud-servicing arrangements. The guidance states that if these fees qualify to be capitalized and amortized over the service period, they need to be expensed in the same line item as the service expense and recognized in the same balance sheet category. The update can be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. The updated guidance is effective for fiscal years beginning after December 31, 2019, and interim periods within those fiscal years. Early adoption is permitted in any interim period. We are currently assessing the effects this updated guidance could have on our consolidated financial statements and timing of adoption. In August 2018, the FASB updated its disclosure requirements related to Level 1, 2 and 3 fair value measurements. The update included deletion and modification of certain disclosure requirements and additional disclosure related to Level 3 measurements. The guidance is effective for fiscal years beginning after December 31, 2019 and early adoption is permitted. We anticipate we will adopt this updated guidance on January 1, 2019 and we do not expect it to have a significant impact on our disclosures. |
Significant Accounting Policies (Tables) |
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Significant Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adjustments Made to Adopt New Revenue Accounting Guidance | The following tables summarize the adjustments we were required to make to amounts we originally reported in 2017 to adopt Topic 606 (in thousands, except per share amounts): Condensed Consolidated Balance Sheet
Condensed Consolidated Statement of Operations
Condensed Consolidated Statement of Cash Flows
The following table summarizes the adjustments we were required to make to our deferred revenue amounts to adopt Topic 606 (in thousands):
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Basic Net Loss per Share | Our basic net loss per share for the three months ended September 30, 2018, was calculated as follows (in thousands, except per share amounts):
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Basic and Diluted Net Income Per Share | For the nine months ended September 30, 2017, we had net income available to Ionis common stockholders. As a result, we computed diluted net income per share using the weighted-average number of common shares and dilutive common equivalent shares outstanding during those periods. Diluted common equivalent shares for the nine months ended September 30, 2017 consisted of the following (in thousands except per share amounts):
For the nine months ended September 30, 2017, the calculation excluded the 1 percent and 2¾ percent notes because the effect on diluted earnings per share was anti-dilutive. |
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Changes in Accumulated Other Comprehensive Income (Loss) | We include unrealized gains and losses on investments, net of taxes, in accumulated other comprehensive income (loss) along with adjustments we make to reclassify realized gains and losses on investments from other accumulated comprehensive income (loss) to our condensed consolidated statement of operations. The following table summarizes changes in accumulated other comprehensive income (loss) for the three and nine months ended September 30, 2018 and 2017 (in thousands):
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Weighted-Average Assumptions for Stock Options | We use the Black-Scholes model to estimate the fair value of stock options granted and stock purchase rights under our ESPP. The expected term of stock options granted represents the period of time that we expect them to be outstanding. We estimate the expected term of options granted based on historical exercise patterns. For the nine months ended September 30, 2018 and 2017, we used the following weighted-average assumptions in our Black-Scholes calculations: Employee Stock Options:
Board of Director Stock Options:
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Weighted-Average Assumptions for ESPP | ESPP:
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Stock-Based Compensation Expense | The following table summarizes stock-based compensation expense for the three and nine months ended September 30, 2018 and 2017 (in thousands). Our consolidated non-cash stock-based compensation expense includes $12.7 million and $4.7 million of stock-based compensation expense for Akcea for the three months ended September 30, 2018 and 2017, respectively, and $31.2 million and $11.8 million for the nine months ended September 30, 2018 and 2017, respectively.
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Investments (Tables) |
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Investments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Contract Maturity of Available-for-Sale Securities | The following table summarizes the contract maturity of the available-for-sale securities we held as of September 30, 2018:
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Summary of Investments | The following is a summary of our investments (in thousands):
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Temporarily Impaired Investments | The following is a summary of our investments we consider to be temporarily impaired at September 30, 2018. We believe that the decline in value of these securities is temporary and is primarily related to the change in market interest rates since purchase. We believe it is more likely than not that we will be able to hold our debt securities to maturity. Therefore, we anticipate full recovery of our debt securities’ amortized cost basis at maturity.
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Fair Value Measurements (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assets Measured at Fair Value on a Recurring Basis | The following tables present the major security types we held at September 30, 2018 and December 31, 2017 that are regularly measured and carried at fair value. At September 30, 2018 and December 31, 2017, we did not have any financial instruments that we valued using Level 3 inputs. The tables segregate each security type by the level within the fair value hierarchy of the valuation techniques we utilized to determine the respective securities’ fair value (in thousands):
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Reconciliation of Assets Measured at Fair Value on a Recurring Basis Using Significant Unobservable Inputs (Level 3) | The following is a reconciliation of the potential premium we would have received if Akcea had not completed its IPO, measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the nine months ended September 30, 2017 (in thousands):
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Collaborative Arrangements and Licensing Agreements (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
AstraZeneca [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements and Licensing Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with AstraZeneca (in millions, except percentage amounts):
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Biogen [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements and Licensing Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with Biogen (in millions, except percentage amounts):
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Bayer [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements and Licensing Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with Bayer (in millions, except percentage amounts):
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Janssen Biotech, Inc. [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements and Licensing Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with Janssen (in millions, except percentage amounts):
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Novartis [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements and Licensing Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with Novartis (in millions, except percentage amounts):
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Roche [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements and Licensing Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with Roche (in millions, except percentage amounts):
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GSK [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements and Licensing Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with GSK (in millions, except percentage amounts):
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PTC Therapeutics [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements and Licensing Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Collaborative Relationship | During the three and nine months ended September 30, 2018 and 2017, we earned the following revenue from our relationship with PTC (in millions, except percentage amounts):
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Segment Information and Concentration of Business Risk (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Information and Concentration of Business Risk [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Information | The following tables show our segment revenue and income (loss) from operations for the three and nine months ended September 30, 2018 and 2017 (in thousands), respectively.
The following table shows our total assets by segment at September 30, 2018 and December 31, 2017 (in thousands), respectively.
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Revenue from Significant Partners | We have historically funded our operations from collaborations with corporate partners and a relatively small number of partners have accounted for a significant percentage of our revenue. Revenue from significant partners, which is defined as ten percent or more of our total revenue, was as follows:
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Basis of Presentation (Details) - Akcea [Member] - shares shares in Millions |
1 Months Ended | 7 Months Ended | |||
---|---|---|---|---|---|
Oct. 31, 2018 |
Jul. 31, 2017 |
Sep. 30, 2018 |
Apr. 30, 2018 |
Mar. 31, 2018 |
|
Basis of Presentation [Abstract] | |||||
Percentage ownership before IPO | 100.00% | ||||
Percentage ownership | 68.00% | 75.00% | 75.00% | 68.00% | |
Subsequent Event [Member] | |||||
Basis of Presentation [Abstract] | |||||
Percentage ownership | 76.00% | ||||
Additional shares of Akcea stock received when TEGSEDI received marketing authorization in the U.S. (in shares) | 1.7 |
Significant Accounting Policies, Noncontrolling Interest in Akcea (Details) - Akcea [Member] - shares shares in Millions |
1 Months Ended | 7 Months Ended | |||
---|---|---|---|---|---|
Oct. 31, 2018 |
Jul. 31, 2017 |
Sep. 30, 2018 |
Apr. 30, 2018 |
Mar. 31, 2018 |
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Noncontrolling Interest in Akcea Therapeutics, Inc. [Abstract] | |||||
Percentage ownership before IPO | 100.00% | ||||
Percentage ownership | 68.00% | 75.00% | 75.00% | 68.00% | |
Subsequent Event [Member] | |||||
Noncontrolling Interest in Akcea Therapeutics, Inc. [Abstract] | |||||
Percentage ownership | 76.00% | ||||
Additional shares of Akcea stock received when TEGSEDI received marketing authorization in the U.S. (in shares) | 1.7 |
Significant Accounting Policies, Cash, Cash Equivalents and Investments (Details) |
Sep. 30, 2018
Company
|
---|---|
Cash, Cash Equivalents and Investments [Abstract] | |
Number of publicly-held companies in which there is an equity ownership interest of less than 20% | 1 |
Number of privately-held companies in which there is an equity ownership interest of less than 20% | 4 |
Significant Accounting Policies, Inventory Valuation (Details) - USD ($) $ in Thousands |
9 Months Ended | |
---|---|---|
Sep. 30, 2018 |
Sep. 30, 2017 |
|
Inventory Valuation [Abstract] | ||
Inventory write-off | $ 0 | $ 0 |
Significant Accounting Policies, Segment Information (Details) |
9 Months Ended |
---|---|
Sep. 30, 2018
Segment
| |
Segment Information [Abstract] | |
Number of operating segments | 2 |
Significant Accounting Policies, Stock-Based Compensation Expense (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2018 |
Sep. 30, 2017 |
Sep. 30, 2018 |
Sep. 30, 2017 |
|
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation expense | $ 34,883 | $ 21,472 | $ 97,210 | $ 63,642 |
Research, Development and Patent [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation expense | 18,780 | 16,181 | 57,698 | 48,443 |
Selling, General and Administrative [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation expense | 16,103 | 5,291 | $ 39,512 | $ 15,199 |
Employee Stock Options [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Risk-free interest rate | 2.30% | 1.80% | ||
Dividend yield | 0.00% | 0.00% | ||
Volatility | 63.10% | 66.10% | ||
Expected life | 4 years 7 months 6 days | 4 years 6 months | ||
Unrecognized Compensation Expense [Abstract] | ||||
Unrecognized compensation expense related to non-vested stock options | 139,500 | $ 139,500 | ||
Weighted average period for recognition | 1 year 3 months 18 days | |||
Board of Director Stock Options [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Risk-free interest rate | 2.80% | 2.20% | ||
Dividend yield | 0.00% | 0.00% | ||
Volatility | 61.50% | 61.20% | ||
Expected life | 6 years 7 months 6 days | 6 years 7 months 6 days | ||
ESPP [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Risk-free interest rate | 1.80% | 0.80% | ||
Dividend yield | 0.00% | 0.00% | ||
Volatility | 47.30% | 59.90% | ||
Expected life | 6 months | 6 months | ||
RSUs [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Vesting period | 4 years | |||
Unrecognized Compensation Expense [Abstract] | ||||
Unrecognized compensation cost related to non-vested RSUs | 32,600 | $ 32,600 | ||
Weighted average period for recognition | 1 year 7 months 6 days | |||
RSUs [Member] | Employees [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Weighted-average grant date fair value (in dollars per share) | $ 51.83 | |||
RSUs [Member] | Board of Directors [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Weighted-average grant date fair value (in dollars per share) | $ 42.88 | |||
Akcea [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation expense | $ 12,700 | $ 4,700 | $ 31,200 | $ 11,800 |
Investments, Contract Maturity of Available-for-Sale Securities (Details) |
9 Months Ended |
---|---|
Sep. 30, 2018
Company
| |
Contract Maturity of Available-for-Sale Securities [Abstract] | |
One year or less | 80.00% |
After one year but within two years | 15.00% |
After two years but within three years | 5.00% |
Total | 100.00% |
Percentage of available-for-sale securities with a maturity of less than two years | 95.00% |
Maximum contract maturity period, range 1 | 1 year |
Maximum contract maturity period, range 2 | 2 years |
Maximum contract maturity period, range 3 | 3 years |
Ownership Interests in Private and Public Companies [Abstract] | |
Number of privately-held companies in which there is an equity ownership interest of less than 20% | 4 |
Number of publicly-held companies in which there is an equity ownership interest of less than 20% | 1 |
Investments, Summary of Investments (Details) - USD ($) $ in Thousands |
Sep. 30, 2018 |
Dec. 31, 2017 |
||||||
---|---|---|---|---|---|---|---|---|
Available-for-sale Securities [Member] | ||||||||
Summary of Investments [Abstract] | ||||||||
Cost | [1] | $ 1,502,739 | $ 911,594 | |||||
Gross unrealized gains | 41 | 14 | ||||||
Gross unrealized losses | (3,942) | (3,072) | ||||||
Estimated fair value | 1,498,838 | 908,536 | ||||||
Available-for-sale Securities [Member] | Securities with Maturity of One Year or Less [Member] | ||||||||
Summary of Investments [Abstract] | ||||||||
Cost | [1] | 1,188,558 | 643,193 | |||||
Gross unrealized gains | 25 | 6 | ||||||
Gross unrealized losses | (1,852) | (1,103) | ||||||
Estimated fair value | 1,186,731 | 642,096 | ||||||
Available-for-sale Securities [Member] | Securities with Maturity of More than One Year [Member] | ||||||||
Summary of Investments [Abstract] | ||||||||
Cost | [1] | 314,181 | 268,401 | |||||
Gross unrealized gains | 16 | 8 | ||||||
Gross unrealized losses | (2,090) | (1,969) | ||||||
Estimated fair value | 312,107 | 266,440 | ||||||
Corporate Debt Securities [Member] | Securities with Maturity of One Year or Less [Member] | ||||||||
Summary of Investments [Abstract] | ||||||||
Cost | [1] | 841,397 | [2] | 500,599 | ||||
Gross unrealized gains | 23 | 2 | ||||||
Gross unrealized losses | (1,264) | (752) | ||||||
Estimated fair value | 840,156 | 499,849 | ||||||
Corporate Debt Securities [Member] | Securities with Maturity of More than One Year [Member] | ||||||||
Summary of Investments [Abstract] | ||||||||
Cost | [1] | 240,208 | 148,663 | |||||
Gross unrealized gains | 16 | 8 | ||||||
Gross unrealized losses | (1,420) | (1,059) | ||||||
Estimated fair value | 238,804 | 147,612 | ||||||
Debt Securities issued by U.S. Government Agencies [Member] | Securities with Maturity of One Year or Less [Member] | ||||||||
Summary of Investments [Abstract] | ||||||||
Cost | [1] | 143,008 | 83,926 | |||||
Gross unrealized gains | 2 | 0 | ||||||
Gross unrealized losses | (169) | (212) | ||||||
Estimated fair value | 142,841 | 83,714 | ||||||
Debt Securities issued by U.S. Government Agencies [Member] | Securities with Maturity of More than One Year [Member] | ||||||||
Summary of Investments [Abstract] | ||||||||
Cost | [1] | 32,435 | 52,779 | |||||
Gross unrealized gains | 0 | 0 | ||||||
Gross unrealized losses | (109) | (168) | ||||||
Estimated fair value | 32,326 | 52,611 | ||||||
Debt Securities issued by the U.S. Treasury [Member] | Securities with Maturity of One Year or Less [Member] | ||||||||
Summary of Investments [Abstract] | ||||||||
Cost | [1] | 154,280 | [2] | 29,428 | ||||
Gross unrealized gains | 0 | 0 | ||||||
Gross unrealized losses | (89) | (17) | ||||||
Estimated fair value | 154,191 | 29,411 | ||||||
Debt Securities issued by the U.S. Treasury [Member] | Securities with Maturity of More than One Year [Member] | ||||||||
Summary of Investments [Abstract] | ||||||||
Cost | 9,872 | [1] | 1,409 | |||||
Gross unrealized gains | 0 | 0 | ||||||
Gross unrealized losses | (10) | (2) | ||||||
Estimated fair value | 9,862 | 1,407 | ||||||
Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | Securities with Maturity of One Year or Less [Member] | ||||||||
Summary of Investments [Abstract] | ||||||||
Cost | [1],[2] | 49,873 | 29,240 | |||||
Gross unrealized gains | 0 | 4 | ||||||
Gross unrealized losses | (330) | (122) | ||||||
Estimated fair value | 49,543 | 29,122 | ||||||
Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | Securities with Maturity of More than One Year [Member] | ||||||||
Summary of Investments [Abstract] | ||||||||
Cost | [1] | 31,666 | 65,550 | |||||
Gross unrealized gains | 0 | 0 | ||||||
Gross unrealized losses | (551) | (740) | ||||||
Estimated fair value | $ 31,115 | $ 64,810 | ||||||
|
Investments, Investments Temporarily Impaired (Details) $ in Thousands |
Sep. 30, 2018
USD ($)
Investment
|
---|---|
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 626 |
Estimated fair value, less than 12 months of temporary impairment | $ 1,211,143 |
Unrealized losses, less than 12 months of temporary impairment | (2,116) |
Estimated fair value, more than 12 months of temporary impairment | 162,315 |
Unrealized losses, more than 12 months of temporary impairment | (1,826) |
Estimated fair value, total temporary impairment | 1,373,458 |
Unrealized losses, total temporary impairment | $ (3,942) |
Corporate Debt Securities [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 495 |
Estimated fair value, less than 12 months of temporary impairment | $ 889,172 |
Unrealized losses, less than 12 months of temporary impairment | (1,687) |
Estimated fair value, more than 12 months of temporary impairment | 83,706 |
Unrealized losses, more than 12 months of temporary impairment | (997) |
Estimated fair value, total temporary impairment | 972,878 |
Unrealized losses, total temporary impairment | $ (2,684) |
Debt Securities issued by U.S. Government Agencies [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 51 |
Estimated fair value, less than 12 months of temporary impairment | $ 132,231 |
Unrealized losses, less than 12 months of temporary impairment | (139) |
Estimated fair value, more than 12 months of temporary impairment | 26,862 |
Unrealized losses, more than 12 months of temporary impairment | (139) |
Estimated fair value, total temporary impairment | 159,093 |
Unrealized losses, total temporary impairment | $ (278) |
Debt Securities issued by the U.S. Treasury [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 32 |
Estimated fair value, less than 12 months of temporary impairment | $ 164,053 |
Unrealized losses, less than 12 months of temporary impairment | (99) |
Estimated fair value, more than 12 months of temporary impairment | 0 |
Unrealized losses, more than 12 months of temporary impairment | 0 |
Estimated fair value, total temporary impairment | 164,053 |
Unrealized losses, total temporary impairment | $ (99) |
Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 48 |
Estimated fair value, less than 12 months of temporary impairment | $ 25,687 |
Unrealized losses, less than 12 months of temporary impairment | (191) |
Estimated fair value, more than 12 months of temporary impairment | 51,747 |
Unrealized losses, more than 12 months of temporary impairment | (690) |
Estimated fair value, total temporary impairment | 77,434 |
Unrealized losses, total temporary impairment | $ (881) |
Fair Value Measurements, Fair Value Measurements on a Recurring Basis (Details) - USD ($) $ in Thousands |
Sep. 30, 2018 |
Dec. 31, 2017 |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fair Value Measurements [Abstract] | |||||||||||||
Transfers from Level 1 to Level 2 | $ 0 | ||||||||||||
Transfers from Level 2 to Level 1 | 0 | ||||||||||||
Recurring Basis [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Cash equivalents | [1] | 395,649 | $ 86,262 | ||||||||||
Total | 1,894,487 | 994,798 | |||||||||||
Recurring Basis [Member] | Corporate Debt Securities [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | 1,078,960 | [2] | 647,461 | [3] | |||||||||
Recurring Basis [Member] | Corporate Debt Securities [Member] | Cash and Cash Equivalents [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | 19,700 | ||||||||||||
Recurring Basis [Member] | Debt Securities issued by U.S. Government Agencies [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | [3] | 175,167 | 136,325 | ||||||||||
Recurring Basis [Member] | Debt Securities issued by the U.S. Treasury [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | [3] | 164,053 | 30,818 | ||||||||||
Recurring Basis [Member] | Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | 80,658 | [3] | 93,932 | [4] | |||||||||
Recurring Basis [Member] | Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | Cash and Cash Equivalents [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | 3,500 | ||||||||||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Cash equivalents | 395,649 | 86,262 | |||||||||||
Total | 559,702 | 117,080 | |||||||||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Corporate Debt Securities [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | 0 | 0 | |||||||||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Debt Securities issued by U.S. Government Agencies [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | 0 | 0 | |||||||||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Debt Securities issued by the U.S. Treasury [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | 164,053 | 30,818 | |||||||||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | 0 | 0 | |||||||||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Cash equivalents | 0 | 0 | |||||||||||
Total | 1,334,785 | 877,718 | |||||||||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Corporate Debt Securities [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | 1,078,960 | [2] | 647,461 | ||||||||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Debt Securities issued by U.S. Government Agencies [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | 175,167 | 136,325 | |||||||||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Debt Securities issued by the U.S. Treasury [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | 0 | 0 | |||||||||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | |||||||||||||
Fair Value Measurements [Abstract] | |||||||||||||
Available-for-sale securities | $ 80,658 | $ 93,932 | |||||||||||
|
Fair Value Measurements, Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (Details) - USD ($) $ in Thousands |
9 Months Ended | |||
---|---|---|---|---|
Sep. 30, 2017 |
Sep. 30, 2018 |
Dec. 31, 2017 |
Jan. 31, 2017 |
|
Novartis [Member] | ||||
Novartis Future Stock Purchase [Abstract] | ||||
Fair value of potential future premium | $ 5,000 | |||
1 Percent Convertible Senior Notes [Member] | ||||
Fair Value Measurements [Abstract] | ||||
Interest rate on convertible senior notes | 1.00% | 1.00% | 1.00% | |
Significant Other Observable Inputs (Level 2) [Member] | 1 Percent Convertible Senior Notes [Member] | ||||
Fair Value Measurements [Abstract] | ||||
Fair value of convertible notes | $ 725,700 | |||
Significant Unobservable Inputs (Level 3) [Member] | ||||
Fair Value Measurements [Abstract] | ||||
Financial instruments | $ 0 | $ 0 | ||
Akcea [Member] | Novartis [Member] | ||||
Novartis Future Stock Purchase [Abstract] | ||||
Additional amount of common stock required to be purchased | $ 50,000 | |||
Potential Future Premium [Member] | ||||
Unobservable Inputs (Level 3) [Roll Forward] | ||||
Beginning balance of Level 3 instruments | $ 0 | |||
Value of the potential premium we would have received from Novartis at inception of the SPA (January 2017) | 5,035 | |||
Recurring fair value adjustment during the nine months ended September 30, 2017 | (5,035) | |||
Ending balance of Level 3 instruments | $ 0 |
Other Obligations, Line of Credit Arrangement (Details) $ in Millions |
9 Months Ended |
---|---|
Sep. 30, 2018
USD ($)
| |
Fixed Rate Note with Morgan Stanley [Member] | |
Line of Credit Arrangement [Abstract] | |
Outstanding borrowings | $ 12.5 |
Interest rate | 2.31% |
Maturity date | Sep. 30, 2019 |
Morgan Stanley [Member] | Revolving Line of Credit [Member] | |
Line of Credit Arrangement [Abstract] | |
Term of agreement | 5 years |
Maximum borrowing capacity | $ 30.0 |
Commitment fee percentage on unused capacity | 0.25% |
Morgan Stanley [Member] | Revolving Line of Credit [Member] | LIBOR [Member] | |
Line of Credit Arrangement [Abstract] | |
Term of variable rate | 1 month |
Basis spread on variable rate | 1.25% |
Term of fixed rate elected | one, two, three, four, six, or twelve months |
Other Obligations, Research and Development and Manufacturing Facilities (Details) - USD ($) $ in Millions |
1 Months Ended | 9 Months Ended |
---|---|---|
Jul. 31, 2017 |
Sep. 30, 2018 |
|
Primary R&D Facility [Member] | ||
Research and Development and Manufacturing Facilities [Abstract] | ||
Payment to acquire building | $ 79.4 | |
Proceeds from mortgage loan | $ 51.3 | |
Interest rate | 3.88% | |
Period to make interest only payments on mortgage loan | 5 years | |
Manufacturing Facility [Member] | ||
Research and Development and Manufacturing Facilities [Abstract] | ||
Payment to acquire building | $ 14.0 | |
Proceeds from mortgage loan | $ 9.1 | |
Interest rate | 4.20% | |
Period to make interest only payments on mortgage loan | 5 years |
Collaborative Arrangements and Licensing Agreements, Biogen (Details) $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Apr. 30, 2018
USD ($)
PerformanceObligation
|
Dec. 31, 2017
USD ($)
PerformanceObligation
|
Jul. 31, 2016
USD ($)
|
Sep. 30, 2013
USD ($)
PerformanceObligation
|
Dec. 31, 2012
USD ($)
PerformanceObligation
Target
Program
|
Sep. 30, 2018
USD ($)
Drug
|
Jun. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Sep. 30, 2018
USD ($)
Drug
|
Sep. 30, 2017
USD ($)
|
Dec. 31, 2017
USD ($)
PerformanceObligation
|
Dec. 31, 2016
PerformanceObligation
|
|
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Revenue | $ 145,395 | $ 118,314 | $ 407,559 | $ 346,387 | ||||||||
Deferred revenue | $ 233,362 | $ 233,362 | ||||||||||
SPINRAZA Royalties [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Revenue | 70,010 | 32,890 | 167,743 | 60,467 | ||||||||
R&D [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Revenue | $ 62,639 | 83,697 | $ 225,584 | 280,281 | ||||||||
Biogen [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Number of additional drugs in clinical development to treat neurodegenerative diseases | Drug | 6 | 6 | ||||||||||
Cumulative payments received | $ 1,900,000 | $ 1,900,000 | ||||||||||
Revenue | 104,800 | $ 87,800 | 234,600 | $ 197,600 | ||||||||
Deferred revenue | $ 93,600 | $ 593,600 | $ 593,600 | 93,600 | ||||||||
Biogen [Member] | Revenue [Member] | Strategic Partner [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Concentration percentage | 72.00% | 74.00% | 58.00% | 57.00% | ||||||||
Biogen [Member] | SPINRAZA Royalties [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Revenue | $ 70,000 | $ 32,900 | $ 167,700 | $ 60,500 | ||||||||
Biogen [Member] | R&D [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Revenue | 34,800 | $ 54,900 | 66,900 | $ 137,100 | ||||||||
SPINRAZA [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Cumulative revenue earned | 717,000 | $ 717,000 | ||||||||||
Number of separate performance obligations | PerformanceObligation | 2 | |||||||||||
Revenue | 10,000 | |||||||||||
SPINRAZA [Member] | Minimum [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Royalty percentage received on net sales of drug | 11.00% | |||||||||||
SPINRAZA [Member] | Maximum [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Royalty percentage received on net sales of drug | 15.00% | |||||||||||
SPINRAZA [Member] | SPINRAZA Royalties [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Cumulative revenue earned | 281,000 | $ 281,000 | ||||||||||
Revenue | $ 75,000 | |||||||||||
SPINRAZA [Member] | R&D [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Cumulative revenue earned | 436,000 | 436,000 | ||||||||||
Revenue | $ 90,000 | |||||||||||
Neurology [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Cumulative payments received | 58,000 | 58,000 | ||||||||||
Number of separate performance obligations | PerformanceObligation | 1 | |||||||||||
Number of targets | Target | 3 | |||||||||||
Number of programs under which drugs are to be developed and commercialized | Program | 3 | |||||||||||
Upfront payment received | $ 30,000 | |||||||||||
Next prospective payment | 7,500 | 7,500 | ||||||||||
Transaction price | $ 30,000 | |||||||||||
Maximum amount of payments receivable per program for license fee and substantive milestone payments | 210,000 | 210,000 | ||||||||||
Maximum amount of payments receivable per program for development milestones | 10,000 | 10,000 | ||||||||||
Maximum amount of payments receivable per program for regulatory milestones | 130,000 | 130,000 | ||||||||||
Neurology [Member] | R&D [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Payments included in transaction price for performance obligation | 40,000 | 40,000 | ||||||||||
2013 Strategic Neurology [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Cumulative payments received | 170,000 | 170,000 | ||||||||||
Number of separate performance obligations | PerformanceObligation | 1 | |||||||||||
Upfront payment received | $ 100,000 | |||||||||||
Next prospective payment | $ 10,000 | $ 10,000 | ||||||||||
Transaction price | $ 100,000 | |||||||||||
Number of drugs currently being advanced | Drug | 5 | 5 | ||||||||||
Revenue | $ 10,000 | |||||||||||
2013 Strategic Neurology [Member] | R&D [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Payments included in transaction price for performance obligation | 145,000 | $ 145,000 | ||||||||||
2013 Strategic Neurology [Member] | Antisense Molecule [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Maximum amount of payments receivable for license fees and substantive milestones | 260,000 | 260,000 | ||||||||||
Maximum amount of payments receivable for development milestones | 60,000 | 60,000 | ||||||||||
Maximum amount of payments receivable for regulatory milestones | 130,000 | 130,000 | ||||||||||
2013 Strategic Neurology [Member] | Other Modalities [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Maximum amount of payments receivable for license fees and substantive milestones | 90,000 | 90,000 | ||||||||||
Maximum amount of payments receivable for development milestones | 35,000 | 35,000 | ||||||||||
Maximum amount of payments receivable for regulatory milestones | 55,000 | $ 55,000 | ||||||||||
New Antisense Drugs for the Treatment of SMA [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Royalty percentage received on net sales of drug | 20.00% | |||||||||||
Number of separate performance obligations | PerformanceObligation | 1 | 1 | ||||||||||
Upfront payment received | $ 25,000 | |||||||||||
Maximum amount of payments receivable for license fees and substantive milestones | 1,200,000 | $ 1,200,000 | ||||||||||
Maximum amount of payments receivable for development milestones | 80,000 | 80,000 | ||||||||||
Maximum amount of payments receivable for commercialization milestones | 180,000 | 180,000 | ||||||||||
Maximum amount of payments receivable for sales milestones | 800,000 | 800,000 | ||||||||||
Next prospective payment | 60,000 | 60,000 | ||||||||||
Transaction price | $ 25,000 | $ 25,000 | ||||||||||
2018 Strategic Neurology [Member] | ||||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||||
Royalty percentage received on net sales of drug | 20.00% | |||||||||||
Number of separate performance obligations | PerformanceObligation | 1 | |||||||||||
Upfront payment received | $ 375,000 | |||||||||||
Next prospective payment | 7,500 | 7,500 | ||||||||||
Transaction price | $ 552,000 | |||||||||||
Maximum amount of payments receivable per program for license fee and substantive milestone payments | $ 270,000 | $ 270,000 | ||||||||||
Term of collaboration agreement | 10 years | |||||||||||
Upfront payment received, including purchase of stock | 1,000,000 | |||||||||||
Proceeds from issuance of common stock | $ 625,000 | |||||||||||
Percentage cash premium paid on shares purchased | 25.00% | |||||||||||
Premium paid on shares purchased | $ 177,000 |
Collaborative Arrangements and Licensing Agreements, AstraZeneca (Details) $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Nov. 06, 2018
USD ($)
Program
|
Jul. 31, 2015
USD ($)
PerformanceObligation
Drug
|
Dec. 31, 2012
USD ($)
PerformanceObligation
|
Sep. 30, 2018
USD ($)
|
Mar. 31, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Dec. 31, 2017
USD ($)
|
Mar. 31, 2014
PerformanceObligation
|
|
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | $ 145,395 | $ 118,314 | $ 407,559 | $ 346,387 | ||||||
Deferred revenue | $ 233,362 | |||||||||
R&D [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | 62,639 | $ 83,697 | 225,584 | $ 280,281 | ||||||
AstraZeneca [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Deferred revenue | $ 44,900 | $ 44,900 | $ 57,700 | |||||||
AstraZeneca [Member] | Revenue [Member] | Strategic Partner [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Concentration percentage | 10.00% | 4.00% | 21.00% | 4.00% | ||||||
AstraZeneca [Member] | R&D [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | $ 14,200 | $ 4,800 | $ 86,500 | $ 14,800 | ||||||
Cardiac, Renal and Metabolic Diseases [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Number of drugs that can be licensed under option in collaboration agreements | Drug | 3 | |||||||||
Upfront payment received | $ 65,000 | |||||||||
Minimum amount of payments receivable for license fees and substantive milestones | 4,000,000 | 4,000,000 | ||||||||
Maximum amount of payments receivable for development milestones | 1,100,000 | 1,100,000 | ||||||||
Maximum amount of payments receivable for regulatory milestones | 2,900,000 | 2,900,000 | ||||||||
Cumulative payments received | 165,000 | 165,000 | ||||||||
Next prospective payment | 10,000 | 10,000 | ||||||||
Number of separate performance obligations | PerformanceObligation | 1 | |||||||||
Transaction price | $ 65,000 | |||||||||
Revenue | 10,000 | |||||||||
Cardiac, Renal and Metabolic Diseases [Member] | IONIS-AZ5-2.5 [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | $ 30,000 | |||||||||
Cardiac, Renal and Metabolic Diseases [Member] | IONIS-AZ6-2.5 [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | $ 30,000 | |||||||||
Cardiac, Renal and Metabolic Diseases [Member] | R&D [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Payments included in transaction price for performance obligation | 90,000 | 90,000 | ||||||||
Oncology [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Upfront payment received | $ 31,000 | |||||||||
Minimum amount of payments receivable for license fees and substantive milestones | 450,000 | 450,000 | ||||||||
Maximum amount of payments receivable for development milestones | 152,000 | 152,000 | ||||||||
Maximum amount of payments receivable for regulatory milestones | 275,000 | 275,000 | ||||||||
Cumulative payments received | 97,800 | 97,800 | ||||||||
Next prospective payment | $ 25,000 | $ 25,000 | ||||||||
Number of separate performance obligations | PerformanceObligation | 4 | |||||||||
Transaction price | $ 31,000 | |||||||||
Number of obligations fully satisfied | PerformanceObligation | 3 | |||||||||
Oncology [Member] | Subsequent Event [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Number of programs advanced | Program | 2 | |||||||||
Revenue | $ 30,000 | |||||||||
Oncology [Member] | R&D [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Transaction price | $ 7,600 |
Collaborative Arrangements and Licensing Agreements, Bayer (Details) $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
---|---|---|---|---|---|---|---|---|
Feb. 28, 2017
USD ($)
PerformanceObligation
|
May 31, 2015
USD ($)
PerformanceObligation
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Jun. 30, 2015
USD ($)
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Dec. 31, 2017
USD ($)
|
|
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Revenue | $ 145,395 | $ 118,314 | $ 407,559 | $ 346,387 | ||||
Deferred revenue | $ 233,362 | |||||||
R&D [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Revenue | 62,639 | $ 83,697 | 225,584 | $ 280,281 | ||||
Bayer [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Maximum amount of payments receivable for license fees and substantive milestones | 385,000 | 385,000 | ||||||
Maximum amount of payments receivable for development milestones | 125,000 | 125,000 | ||||||
Maximum amount of payments receivable for commercialization milestones | 110,000 | 110,000 | ||||||
Cumulative payments received | 175,000 | 175,000 | ||||||
Next prospective milestone | 10,000 | 10,000 | ||||||
Number of separate performance obligations | PerformanceObligation | 3 | |||||||
Deferred revenue | $ 6,000 | $ 6,000 | $ 9,300 | |||||
Bayer [Member] | Revenue [Member] | Strategic Partner [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Concentration percentage | 1.00% | 0.00% | 1.00% | 19.00% | ||||
Bayer [Member] | Minimum [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Royalty percentage received on gross margins of both drugs combined | 20.00% | |||||||
Bayer [Member] | R&D [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Revenue | $ 1,900 | $ 400 | $ 3,300 | $ 66,000 | ||||
Bayer [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Upfront payment received | $ 100,000 | $ 100,000 | ||||||
Number of separate performance obligations | PerformanceObligation | 3 | |||||||
Transaction price | $ 100,000 | |||||||
Bayer [Member] | IONIS-FXI [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Transaction price | 91,200 | |||||||
Revenue | 91,200 | |||||||
Bayer [Member] | R&D Services for IONIS-FXI [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Transaction price | 4,300 | |||||||
Bayer [Member] | IONIS-FXI API [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Transaction price | $ 4,500 | |||||||
Bayer [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Upfront payment received | $ 75,000 | |||||||
Payment received for advancing programs | $ 75,000 | |||||||
Number of separate performance obligations | PerformanceObligation | 2 | |||||||
Transaction price | $ 75,000 | |||||||
Bayer [Member] | IONIS-FXI-L [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Transaction price | 64,900 | |||||||
Bayer [Member] | R&D Services for IONIS-FXI-L [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Transaction price | $ 10,100 |
Collaborative Arrangements and Licensing Agreements, Janssen Biotech, Inc. (Details) $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | 17 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Jan. 31, 2018
USD ($)
|
Nov. 30, 2017
USD ($)
|
Jul. 31, 2016
USD ($)
|
Dec. 31, 2014
USD ($)
PerformanceObligation
Program
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Nov. 30, 2017
USD ($)
|
Dec. 31, 2017
USD ($)
|
|
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | $ 145,395 | $ 118,314 | $ 407,559 | $ 346,387 | ||||||
Deferred revenue | $ 233,362 | |||||||||
Licensing and Other Royalties [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | 12,746 | 1,727 | 14,232 | 5,639 | ||||||
R&D [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | 62,639 | $ 83,697 | 225,584 | $ 280,281 | ||||||
Janssen Biotech, Inc. [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Number of programs under which drugs are to be developed and commercialized | Program | 3 | |||||||||
Upfront payment received | $ 35,000 | |||||||||
Minimum amount of payments receivable for license fees and substantive milestones | 800,000 | 800,000 | ||||||||
Maximum amount of payments receivable for development milestones | 175,000 | 175,000 | ||||||||
Maximum amount of payments receivable for regulatory milestones | 440,000 | 440,000 | ||||||||
Maximum amount of payments receivable for commercialization milestones | 180,000 | 180,000 | ||||||||
Cumulative payments received | 75,000 | 75,000 | ||||||||
Next prospective milestone | 5,000 | 5,000 | ||||||||
Number of separate performance obligations | PerformanceObligation | 1 | |||||||||
Transaction price | $ 35,000 | |||||||||
Deferred revenue | $ 0 | $ 0 | $ 0 | |||||||
Janssen Biotech, Inc. [Member] | Revenue [Member] | Strategic Partner [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Concentration percentage | 1.00% | 3.00% | 2.00% | 5.00% | ||||||
Janssen Biotech, Inc. [Member] | Licensing and Other Royalties [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | $ 15,000 | |||||||||
Janssen Biotech, Inc. [Member] | IONIS-JBI1-2.5 [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | $ 5,000 | $ 10,000 | ||||||||
Janssen Biotech, Inc. [Member] | IONIS-JBI2-2.5 [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | $ 5,000 | |||||||||
Janssen Biotech, Inc. [Member] | R&D [Member] | ||||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||||
Revenue | $ 900 | $ 3,400 | $ 6,600 | $ 18,100 |
Collaborative Arrangements and Licensing Agreements, Roche (Details) $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|---|
Oct. 31, 2018
USD ($)
|
Jan. 31, 2018
USD ($)
|
Dec. 31, 2016
USD ($)
|
Apr. 30, 2013
USD ($)
PerformanceObligation
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Dec. 31, 2017
USD ($)
|
|
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Revenue | $ 145,395 | $ 118,314 | $ 407,559 | $ 346,387 | |||||
Deferred revenue | $ 233,362 | ||||||||
R&D [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Revenue | 62,639 | $ 83,697 | 225,584 | $ 280,281 | |||||
Roche [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Deferred revenue | $ 0 | $ 0 | $ 0 | ||||||
Roche [Member] | Revenue [Member] | Strategic Partner [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Concentration percentage | 1.00% | 4.00% | 1.00% | 2.00% | |||||
Roche [Member] | R&D [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Revenue | $ 1,800 | $ 4,500 | $ 5,400 | $ 5,900 | |||||
Huntington's Disease [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Upfront payment received | $ 30,000 | ||||||||
Milestone payments received | $ 3,000 | ||||||||
Maximum amount of payments receivable for license fees and substantive milestones | 365,000 | 365,000 | |||||||
Maximum amount of payments receivable for development milestones | 70,000 | 70,000 | |||||||
Maximum amount of payments receivable for regulatory milestones | 170,000 | 170,000 | |||||||
Maximum amount of payments receivable for commercialization milestones | 80,000 | 80,000 | |||||||
Maximum amount of payment receivable for each additional drug developed | 136,500 | 136,500 | |||||||
Cumulative payments received | 110,000 | 110,000 | |||||||
Next prospective milestone | $ 35,000 | $ 35,000 | |||||||
Number of separate performance obligations | PerformanceObligation | 1 | ||||||||
Transaction price | $ 30,000 | ||||||||
Huntington's Disease [Member] | IONIS-HTT [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Revenue | $ 45,000 | ||||||||
IONIS-FB-L [Member] | Subsequent Event [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Upfront payment received | $ 75,000 | ||||||||
Maximum amount of payments receivable for license fees and substantive milestones | 684,000 | ||||||||
Next prospective milestone | $ 20,000 | ||||||||
Royalty percentage received on net sales of drug | 20.00% |
Collaborative Arrangements and Licensing Agreements, GSK (Details) $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|---|
Mar. 31, 2010
USD ($)
PerformanceObligation
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Sep. 30, 2018
USD ($)
Drug
|
Sep. 30, 2017
USD ($)
|
Dec. 31, 2017
USD ($)
|
|
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 145,395 | $ 118,314 | $ 407,559 | $ 346,387 | ||
Deferred revenue | $ 233,362 | |||||
R&D [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | 62,639 | $ 83,697 | $ 225,584 | $ 280,281 | ||
GSK [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Upfront payment received | $ 35,000 | |||||
Number of antisense drugs in development | Drug | 2 | |||||
Maximum amount of payments receivable for license fees and substantive milestones | 262,000 | $ 262,000 | ||||
Maximum amount of payments receivable for development milestones | 47,500 | 47,500 | ||||
Maximum amount of payments receivable for regulatory milestones | 120,000 | 120,000 | ||||
Maximum amount of payments receivable for commercialization milestones | 70,000 | 70,000 | ||||
Number of separate performance obligations | PerformanceObligation | 1 | |||||
Transaction price | $ 35,000 | |||||
Deferred revenue | $ 0 | $ 0 | $ 0 | |||
GSK [Member] | Revenue [Member] | Strategic Partner [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Concentration percentage | 0.00% | 4.00% | 0.00% | 4.00% | ||
GSK [Member] | Minimum [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Cumulative payments received | $ 162,000 | $ 162,000 | ||||
GSK [Member] | Maximum [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Next prospective milestone | 25,000 | 25,000 | ||||
GSK [Member] | R&D [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 100 | $ 4,600 | $ 1,500 | $ 14,400 |
Collaborative Arrangements and Licensing Agreements, Novartis (Details) $ in Thousands, shares in Millions |
1 Months Ended | 3 Months Ended | 9 Months Ended | |||||
---|---|---|---|---|---|---|---|---|
Jul. 31, 2017
USD ($)
|
Jan. 31, 2017
Drug
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Mar. 31, 2017
USD ($)
PerformanceObligation
shares
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Dec. 31, 2017
USD ($)
|
|
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Proceeds from sale of common stock to Novartis in a private placement | $ 0 | $ 50,000 | ||||||
Revenue | $ 145,395 | $ 118,314 | 407,559 | 346,387 | ||||
Deferred revenue | $ 233,362 | |||||||
R&D [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Revenue | 62,639 | $ 83,697 | 225,584 | $ 280,281 | ||||
Novartis [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Shares issued (in shares) | shares | 1.6 | |||||||
Proceeds from sale of common stock | $ 100,000 | |||||||
Number of separate performance obligations | PerformanceObligation | 4 | |||||||
Transaction price | $ 108,400 | |||||||
Premium received on shares issued | 28,400 | |||||||
Potential premium received if common stock is purchased in the future | 5,000 | |||||||
Deferred revenue | $ 34,800 | $ 34,800 | $ 70,700 | |||||
Novartis [Member] | Revenue [Member] | Strategic Partner [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Concentration percentage | 5.00% | 8.00% | 10.00% | 6.00% | ||||
Novartis [Member] | Minimum [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Number of drugs with exclusive option that could be exercised | Drug | 1 | |||||||
Novartis [Member] | R&D Services for AKCEA-APO(a)-L [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Transaction price | 64,000 | |||||||
Novartis [Member] | Delivery of AKCEA-APO(a)-L [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Transaction price | 1,500 | |||||||
Novartis [Member] | R&D Services for AKCEA-APOCIII-L [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Transaction price | 40,100 | |||||||
Novartis [Member] | Delivery of AKCEA-APOCIII-L [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Transaction price | 2,800 | |||||||
Novartis [Member] | R&D [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Revenue | $ 7,200 | $ 9,900 | $ 42,700 | $ 21,700 | ||||
Akcea [Member] | Novartis [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Upfront payment received | 75,000 | |||||||
Portion of upfront payment retained | 60,000 | |||||||
Portion of upfront payment paid as a sublicense fee | $ 15,000 | |||||||
License fee receivable per drug | 150,000 | $ 150,000 | ||||||
Percentage of license fees, milestone payments and royalties paid as sublicense fee | 50.00% | |||||||
Proceeds from sale of common stock to Novartis in a private placement | $ 50,000 | |||||||
Akcea [Member] | Novartis [Member] | AKCEA-APO(a)-L [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Maximum amount of payments receivable for milestones | 600,000 | $ 600,000 | ||||||
Maximum amount of payments receivable for development milestones | 25,000 | 25,000 | ||||||
Maximum amount of payments receivable for regulatory milestones | 290,000 | 290,000 | ||||||
Maximum amount of payments receivable for commercialization milestones | 285,000 | $ 285,000 | ||||||
Royalty percentage received on sales of drug | 20.00% | |||||||
Akcea [Member] | Novartis [Member] | AKCEA-APOCIII-L [Member] | ||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||||
Maximum amount of payments receivable for milestones | 530,000 | $ 530,000 | ||||||
Maximum amount of payments receivable for development milestones | 25,000 | 25,000 | ||||||
Maximum amount of payments receivable for regulatory milestones | 240,000 | 240,000 | ||||||
Maximum amount of payments receivable for commercialization milestones | $ 265,000 | $ 265,000 | ||||||
Royalty percentage received on sales of drug | 20.00% |
Collaborative Arrangements and Licensing Agreements, PTC Therapeutics (Details) $ in Thousands |
1 Months Ended | 3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|---|
Aug. 31, 2018
USD ($)
PerformanceObligation
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Dec. 31, 2017
USD ($)
|
|
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 145,395 | $ 118,314 | $ 407,559 | $ 346,387 | ||
Deferred revenue | $ 233,362 | |||||
PTC Therapeutics [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Number of separate performance obligations | PerformanceObligation | 2 | |||||
Revenue | 12,000 | $ 0 | 12,000 | $ 0 | ||
Deferred revenue | $ 0 | $ 0 | $ 0 | |||
PTC Therapeutics [Member] | Revenue [Member] | Strategic Partner [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Concentration percentage | 8.00% | 0.00% | 3.00% | 0.00% | ||
PTC Therapeutics [Member] | Sublicense Revenue [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 7,200 | |||||
Akcea [Member] | PTC Therapeutics [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Payment receivable under license agreement | 26,000 | $ 26,000 | ||||
Payment received under license agreement | 12,000 | |||||
Payment to be received on earlier of FDA or EMA approval of WAYLIVRA | 6,000 | 6,000 | ||||
Maximum amount of payments receivable per drug for regulatory milestones | $ 8,000 | $ 8,000 | ||||
Royalty percentage received on net sales of each drug in Latin America from PTC | 20.00% | |||||
Period before PTC pays royalties on net sales of product after first commercial sale in Brazil | 12 months | |||||
Minimum revenue recognized in Latin America by PTC before paying royalties | $ 10,000 | |||||
Akcea [Member] | PTC Therapeutics [Member] | License Fees [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 12,000 |
Segment Information and Concentration of Business Risk, Segment Information (Details) $ in Thousands, shares in Millions |
1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|---|
Oct. 31, 2018
shares
|
Sep. 30, 2018
USD ($)
|
Sep. 30, 2017
USD ($)
|
Sep. 30, 2018
USD ($)
Segment
|
Sep. 30, 2017
USD ($)
|
Apr. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2017
USD ($)
|
Jul. 31, 2017 |
|
Segment Information and Concentration of Business Risk [Abstract] | |||||||||
Number of reportable segments | Segment | 2 | ||||||||
Segment Information [Abstract] | |||||||||
Revenue | $ 145,395 | $ 118,314 | $ 407,559 | $ 346,387 | |||||
Total operating expenses | 163,967 | 107,002 | 479,716 | 309,140 | |||||
Income (loss) from operations | (18,572) | 11,312 | (72,157) | 37,247 | |||||
Total assets as of current period | 2,247,913 | 2,247,913 | $ 1,322,774 | ||||||
Commercial Revenue [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 82,756 | 34,617 | 181,975 | 66,106 | |||||
SPINRAZA Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 70,010 | 32,890 | 167,743 | 60,467 | |||||
Licensing and Other Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 12,746 | 1,727 | 14,232 | 5,639 | |||||
R&D Revenue Under Collaborative Agreements [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | $ 62,639 | 83,697 | $ 225,584 | 280,281 | |||||
Akcea [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Percentage ownership | 75.00% | 75.00% | 75.00% | 68.00% | 68.00% | ||||
Akcea [Member] | Subsequent Event [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Percentage ownership | 76.00% | ||||||||
Additional shares of Akcea stock received when TEGSEDI received marketing authorization in the U.S. (in shares) | shares | 1.7 | ||||||||
Operating Segments [Member] | Ionis Core [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | $ 178,061 | 108,408 | $ 410,025 | 379,082 | |||||
Total operating expenses | 87,664 | 81,019 | 279,084 | 242,753 | |||||
Income (loss) from operations | 90,397 | 27,389 | 130,941 | 136,329 | |||||
Total assets as of current period | 2,446,425 | 2,446,425 | 1,342,578 | ||||||
Operating Segments [Member] | Ionis Core [Member] | Commercial Revenue [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 77,956 | 34,617 | 177,175 | 66,106 | |||||
Operating Segments [Member] | Ionis Core [Member] | SPINRAZA Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 70,010 | 32,890 | 167,743 | 60,467 | |||||
Operating Segments [Member] | Ionis Core [Member] | Licensing and Other Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 7,946 | 1,727 | 9,432 | 5,639 | |||||
Operating Segments [Member] | Ionis Core [Member] | R&D Revenue Under Collaborative Agreements [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 100,105 | 73,791 | 232,850 | 312,976 | |||||
Operating Segments [Member] | Akcea Therapeutics [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 19,241 | 9,906 | 54,670 | 21,712 | |||||
Total operating expenses | 84,249 | 26,013 | 213,428 | 120,884 | |||||
Income (loss) from operations | (65,008) | (16,107) | (158,758) | (99,172) | |||||
Total assets as of current period | 379,128 | 379,128 | 268,804 | ||||||
Operating Segments [Member] | Akcea Therapeutics [Member] | Commercial Revenue [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 12,000 | 0 | 12,000 | 0 | |||||
Operating Segments [Member] | Akcea Therapeutics [Member] | SPINRAZA Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 0 | 0 | 0 | 0 | |||||
Operating Segments [Member] | Akcea Therapeutics [Member] | Licensing and Other Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 12,000 | 0 | 12,000 | 0 | |||||
Operating Segments [Member] | Akcea Therapeutics [Member] | R&D Revenue Under Collaborative Agreements [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 7,241 | 9,906 | 42,670 | 21,712 | |||||
Elimination of Intercompany Activity [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | (51,907) | 0 | (57,136) | (54,407) | |||||
Total operating expenses | (7,946) | (30) | (12,796) | (54,497) | |||||
Income (loss) from operations | (43,961) | 30 | (44,340) | 90 | |||||
Total assets as of current period | (577,641) | (577,641) | $ (288,608) | ||||||
Elimination of Intercompany Activity [Member] | Commercial Revenue [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | (7,200) | 0 | (7,200) | 0 | |||||
Elimination of Intercompany Activity [Member] | SPINRAZA Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | 0 | 0 | 0 | 0 | |||||
Elimination of Intercompany Activity [Member] | Licensing and Other Royalties [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | (7,200) | 0 | (7,200) | 0 | |||||
Elimination of Intercompany Activity [Member] | R&D Revenue Under Collaborative Agreements [Member] | |||||||||
Segment Information [Abstract] | |||||||||
Revenue | $ (44,707) | $ 0 | $ (49,936) | $ (54,407) |
Segment Information and Concentration of Business Risk, Revenue from Significant Partners (Details) - Partner |
3 Months Ended | 9 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Sep. 30, 2018 |
Sep. 30, 2017 |
Sep. 30, 2018 |
Sep. 30, 2017 |
Dec. 31, 2017 |
|
Revenue [Member] | Customer Concentration [Member] | Partner A [Member] | |||||
Significant Partners [Abstract] | |||||
Concentration percentage | 72.00% | 74.00% | 58.00% | 57.00% | |
Revenue [Member] | Customer Concentration [Member] | Partner B [Member] | |||||
Significant Partners [Abstract] | |||||
Concentration percentage | 10.00% | 4.00% | 21.00% | 4.00% | |
Revenue [Member] | Customer Concentration [Member] | Partner C [Member] | |||||
Significant Partners [Abstract] | |||||
Concentration percentage | 5.00% | 8.00% | 10.00% | 6.00% | |
Revenue [Member] | Customer Concentration [Member] | Partner D [Member] | |||||
Significant Partners [Abstract] | |||||
Concentration percentage | 8.00% | 0.00% | 3.00% | 0.00% | |
Revenue [Member] | Customer Concentration [Member] | Partner E [Member] | |||||
Significant Partners [Abstract] | |||||
Concentration percentage | 1.00% | 0.00% | 1.00% | 19.00% | |
Contracts Receivables [Member] | Credit Concentration [Member] | Significant Partners [Member] | |||||
Significant Partners [Abstract] | |||||
Concentration percentage | 84.00% | 84.00% | |||
Number of significant partners | 2 | 2 |
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