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
|
Trading symbol
|
||
Common Stock, $.001 Par Value
|
The Nasdaq Stock Market, LLC
|
“IONS”
|
Large accelerated filer
|
Accelerated filer
|
Non-accelerated filer
|
Smaller reporting company
|
Emerging growth company
|
PART I
|
FINANCIAL INFORMATION
|
|
ITEM 1:
|
Financial Statements:
|
|
Condensed Consolidated Balance Sheets as of March 31, 2019 (unaudited) and December 31, 2018
|
3
|
|
Condensed Consolidated Statements of Operations for the three months ended March 31, 2019 and 2018 (unaudited)
|
4
|
|
Condensed Consolidated Statements of Comprehensive Income (Loss) for the three months ended March 31, 2019 and
2018 (unaudited)
|
5
|
|
Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2019 and 2018
(unaudited)
|
6
|
|
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2019 and 2018 (unaudited)
|
7
|
|
Notes to Condensed Consolidated Financial Statements (unaudited)
|
8
|
|
ITEM 2:
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations:
|
|
Overview
|
25
|
|
Results of Operations
|
27
|
|
Liquidity and Capital Resources
|
33
|
|
ITEM 3:
|
Quantitative and Qualitative Disclosures about Market Risk
|
34
|
ITEM 4:
|
Controls and Procedures
|
35
|
PART II
|
OTHER INFORMATION
|
35
|
ITEM 1:
|
Legal Proceedings
|
35
|
ITEM 1A:
|
Risk Factors
|
35
|
ITEM 2:
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
44 |
ITEM 3:
|
Default upon Senior Securities
|
44 |
ITEM 4:
|
Mine Safety Disclosures
|
39
|
ITEM 5:
|
Other Information
|
44
|
ITEM 6:
|
Exhibits
|
44
|
SIGNATURES
|
46 |
March 31,
2019
|
December 31,
2018
|
|||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
375,811
|
$
|
278,820
|
||||
Short-term investments
|
1,877,943
|
1,805,252
|
||||||
Contracts receivable
|
10,452
|
12,759
|
||||||
Inventories
|
11,057
|
8,582
|
||||||
Other current assets
|
98,686
|
102,473
|
||||||
Total current assets
|
2,373,949
|
2,207,886
|
||||||
Property, plant and equipment, net
|
133,519
|
132,160
|
||||||
Patents, net
|
25,220
|
24,032
|
||||||
Long-term deferred tax assets
|
277,247
|
290,796
|
||||||
Deposits and other assets
|
25,954
|
12,910
|
||||||
Total assets
|
$
|
2,835,889
|
$
|
2,667,784
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
13,332
|
$
|
28,660
|
||||
Accrued compensation
|
16,264
|
29,268
|
||||||
Accrued liabilities
|
45,130
|
47,503
|
||||||
Income taxes payable
|
18,401
|
858
|
||||||
Current portion of long-term obligations
|
14,500
|
13,749
|
||||||
Current portion of deferred contract revenue
|
144,846
|
160,256
|
||||||
Total current liabilities
|
252,473
|
280,294
|
||||||
Long-term deferred contract revenue
|
542,416
|
567,359
|
||||||
1 percent convertible senior notes
|
577,415
|
568,215
|
||||||
Long-term obligations, less current portion
|
16,305
|
4,914
|
||||||
Long-term mortgage debt
|
59,860
|
59,842
|
||||||
Total liabilities
|
1,448,469
|
1,480,624
|
||||||
Stockholders’ equity:
|
||||||||
Common stock, $0.001 par value; 300,000,000 shares authorized, 139,623,937 and 137,928,828 shares
issued and outstanding at March 31, 2019 (unaudited) and December 31, 2018, respectively
|
140
|
138
|
||||||
Additional paid-in capital
|
2,117,969
|
2,047,250
|
||||||
Accumulated other comprehensive loss
|
(27,608
|
)
|
(32,016
|
)
|
||||
Accumulated deficit
|
(882,850
|
)
|
(967,293
|
)
|
||||
Total Ionis stockholders’ equity
|
1,207,651
|
1,048,079
|
||||||
Noncontrolling interest in Akcea Therapeutics, Inc.
|
179,769
|
139,081
|
||||||
Total stockholders’ equity
|
1,387,420
|
1,187,160
|
||||||
Total liabilities and stockholders’ equity
|
$
|
2,835,889
|
$
|
2,667,784
|
|
Three Months Ended
March 31,
|
|||||||
|
2019
|
2018
|
||||||
Revenue:
|
||||||||
Commercial revenue:
|
||||||||
SPINRAZA royalties
|
$
|
59,711
|
$
|
41,081
|
||||
TEGSEDI product sales, net
|
6,754
|
—
|
||||||
Licensing and other royalty revenue
|
1,623
|
942
|
||||||
Total commercial revenue
|
68,088
|
42,023
|
||||||
Research and development revenue under collaborative agreements
|
229,126
|
102,396
|
||||||
Total revenue
|
297,214
|
144,419
|
||||||
|
||||||||
Expenses:
|
||||||||
Cost of products sold
|
1,041
|
—
|
||||||
Research, development and patent
|
106,417
|
104,067
|
||||||
Selling, general and administrative
|
68,221
|
43,653
|
||||||
Total operating expenses
|
175,679
|
147,720
|
||||||
|
||||||||
Income (loss) from operations
|
121,535
|
(3,301
|
)
|
|||||
|
||||||||
Other income (expense):
|
||||||||
Investment income
|
12,142
|
3,610
|
||||||
Interest expense
|
(11,599
|
)
|
(10,938
|
)
|
||||
Other expenses
|
(147
|
)
|
(168
|
)
|
||||
|
||||||||
Income (loss) before income tax expense
|
121,931
|
(10,797
|
)
|
|||||
|
||||||||
Income tax expense
|
(31,047
|
)
|
(15
|
)
|
||||
|
||||||||
Net income (loss)
|
90,884
|
(10,812
|
)
|
|||||
Net (income) loss attributable to noncontrolling interest in Akcea Therapeutics, Inc.
|
(6,441
|
)
|
9,392
|
|||||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders
|
$
|
84,443
|
$
|
(1,420
|
)
|
|||
Basic net income (loss) per share
|
$
|
0.63
|
$
|
(0.01
|
)
|
|||
Shares used in computing basic net income (loss) per share
|
138,582
|
125,330
|
||||||
Diluted net income (loss) per share
|
$
|
0.62
|
$
|
(0.01
|
)
|
|||
Shares used in computing diluted net income (loss) per share
|
141,537
|
125,330
|
Three Months Ended
March 31,
|
||||||||
|
2019
|
2018
|
||||||
Net income (loss)
|
$
|
90,884
|
$
|
(10,812
|
)
|
|||
Unrealized gains (losses) on debt securities, net of tax
|
4,324
|
(1,530
|
)
|
|||||
Currency translation adjustment
|
84
|
55
|
||||||
|
||||||||
Comprehensive income (loss)
|
95,292
|
(12,287
|
)
|
|||||
Comprehensive (income) loss attributable to noncontrolling interests
|
6,442
|
(9,399
|
)
|
|||||
Comprehensive income (loss) attributable to Ionis Pharmaceuticals, Inc. stockholders
|
$
|
88,850
|
$
|
(2,888
|
)
|
Common Stock
|
Additional Paid in
|
Accumulated
Other
Comprehensive
|
Accumulated
|
Total Ionis
Stockholders’
|
Noncontrolling
Interest in Akcea
|
Total
Stockholders’
|
||||||||||||||||||||||||||
Description
|
Shares
|
Amount
|
Capital
|
Loss
|
Deficit
|
Equity
|
Therapeutics, Inc.
|
Equity
|
||||||||||||||||||||||||
Balance at December 31, 2017
|
124,976
|
$
|
125
|
$
|
1,553,681
|
$
|
(31,759
|
)
|
$
|
(1,241,034
|
)
|
$
|
281,013
|
$
|
84,267
|
$
|
365,280
|
|||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(1,420
|
)
|
(1,420
|
)
|
—
|
(1,420
|
)
|
|||||||||||||||||||||
Change in unrealized gains (losses), net of tax
|
—
|
—
|
—
|
(1,530
|
)
|
—
|
(1,530
|
)
|
—
|
(1,530
|
)
|
|||||||||||||||||||||
Foreign currency translation
|
—
|
—
|
—
|
55
|
—
|
55
|
—
|
55
|
||||||||||||||||||||||||
Issuance of common stock in connection with employee stock plans
|
473
|
—
|
5,664
|
—
|
—
|
5,664
|
—
|
5,664
|
||||||||||||||||||||||||
Stock-based compensation expense
|
—
|
—
|
28,451
|
—
|
—
|
28,451
|
—
|
28,451
|
||||||||||||||||||||||||
Noncontrolling interest in Akcea Therapeutics, Inc
|
—
|
—
|
(10,842
|
)
|
—
|
—
|
(10,842
|
)
|
1,443
|
(9,399
|
)
|
|||||||||||||||||||||
Balance at March 31, 2018
|
125,449
|
$
|
125
|
$
|
1,576,954
|
$
|
(33,234
|
)
|
$
|
(1,242,454
|
)
|
$
|
301,391
|
$
|
85,710
|
$
|
387,101
|
|||||||||||||||
Balance at December 31, 2018
|
137,929
|
$
|
138
|
$
|
2,047,250
|
$
|
(32,016
|
)
|
$
|
(967,293
|
)
|
$
|
1,048,079
|
$
|
139,081
|
$
|
1,187,160
|
|||||||||||||||
Net income
|
—
|
—
|
—
|
—
|
84,443
|
84,443
|
—
|
84,443
|
||||||||||||||||||||||||
Change in unrealized gains (losses), net of tax
|
—
|
—
|
—
|
4,324
|
—
|
4,324
|
—
|
4,324
|
||||||||||||||||||||||||
Foreign currency translation
|
—
|
—
|
—
|
84
|
—
|
84
|
—
|
84
|
||||||||||||||||||||||||
Issuance of common stock in connection with employee stock plans
|
1,825
|
2
|
67,057
|
—
|
—
|
67,059
|
—
|
67,059
|
||||||||||||||||||||||||
Stock-based compensation expense
|
—
|
—
|
45,505
|
—
|
—
|
45,505
|
—
|
45,505
|
||||||||||||||||||||||||
Payments of tax withholdings related to vesting of employee stock awards
|
(130
|
)
|
—
|
(7,597
|
)
|
—
|
—
|
(7,597
|
)
|
—
|
(7,597
|
)
|
||||||||||||||||||||
Noncontrolling interest in Akcea Therapeutics, Inc.
|
—
|
—
|
(34,246
|
)
|
—
|
—
|
(34,246
|
)
|
40,688
|
6,442
|
||||||||||||||||||||||
Balance at March 31, 2019
|
139,624
|
$
|
140
|
$
|
2,117,969
|
$
|
(27,608
|
)
|
$
|
(882,850
|
)
|
$
|
1,207,651
|
$
|
179,769
|
$
|
1,387,420
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Operating activities:
|
||||||||
Net income (loss)
|
$
|
90,884
|
$
|
(10,812
|
)
|
|||
Adjustments to reconcile net loss to net cash provided by operating activities:
|
||||||||
Depreciation
|
3,073
|
2,363
|
||||||
Amortization of patents
|
470
|
443
|
||||||
Amortization of premium on investments, net
|
(2,433
|
)
|
1,192
|
|||||
Amortization of debt issuance costs
|
474
|
441
|
||||||
Amortization of convertible senior notes discount
|
8,726
|
8,083
|
||||||
Stock-based compensation expense
|
45,505
|
28,451
|
||||||
Non-cash losses related to patents, licensing and property, plant and equipment
|
14
|
175
|
||||||
Provision for deferred income taxes
|
13,549
|
—
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Contracts receivable
|
4,908
|
26,097
|
||||||
Inventories
|
(2,475
|
)
|
922
|
|||||
Other current and long-term assets
|
1,802
|
11,422
|
||||||
Accounts payable
|
(17,191
|
)
|
(13,144
|
)
|
||||
Accrued compensation
|
(13,004
|
)
|
(12,985
|
)
|
||||
Accrued liabilities and deferred rent
|
13,756
|
(1,695
|
)
|
|||||
Deferred contract revenue
|
(40,353
|
)
|
(27,788
|
)
|
||||
Net cash provided by operating activities
|
107,705
|
13,165
|
||||||
Investing activities:
|
||||||||
Purchases of short-term investments
|
(492,781
|
)
|
(91,157
|
)
|
||||
Proceeds from the sale of short-term investments
|
426,868
|
173,724
|
||||||
Purchases of property, plant and equipment
|
(3,229
|
)
|
(2,343
|
)
|
||||
Acquisition of licenses and other assets, net
|
(1,032
|
)
|
(738
|
)
|
||||
Net cash provided by (used in) investing activities
|
(70,174
|
)
|
79,486
|
|||||
Financing activities:
|
||||||||
Proceeds from equity awards
|
67,057
|
5,675
|
||||||
Payments of tax withholdings related to vesting of employee stock awards
|
(7,597
|
)
|
—
|
|||||
Offering costs paid
|
—
|
(451
|
)
|
|||||
Net cash provided by financing activities
|
59,460
|
5,224
|
||||||
Net increase in cash and cash equivalents
|
96,991
|
97,875
|
||||||
Cash and cash equivalents at beginning of period
|
278,820
|
129,630
|
||||||
Cash and cash equivalents at end of period
|
$
|
375,811
|
$
|
227,505
|
||||
Supplemental disclosures of cash flow information:
|
||||||||
Interest paid
|
$
|
667
|
$
|
644
|
||||
Supplemental disclosures of non-cash investing and financing activities:
|
||||||||
Right-of-use assets obtained in exchange for lease liabilities
|
$
|
13,557
|
$
|
—
|
||||
Amounts accrued for capital and patent expenditures
|
$
|
1,864
|
$
|
2,091
|
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 March 31, 2019
|
Weighted
Average Shares
Owned in Akcea
|
Akcea’s
Net Income
Per Share
|
Ionis’ Portion of
Akcea’s Net Loss
|
|||||||||
Common shares
|
68,582
|
$
|
0.35
|
$
|
23,846
|
|||||||
Akcea’s net income attributable to our ownership
|
$
|
23,846
|
||||||||||
Ionis’ stand-alone net income
|
63,697
|
|||||||||||
Net income available to Ionis common stockholders
|
$
|
87,543
|
||||||||||
Weighted average shares outstanding
|
138,582
|
|||||||||||
Basic net income per share
|
$
|
0.63
|
Three months ended March 31, 2018
|
Weighted
Average Shares
Owned in Akcea
|
Akcea’s
Net Loss
Per Share
|
Ionis’ Portion of
Akcea’s Net Loss
|
|||||||||
Common shares
|
45,448
|
$
|
(0.44
|
)
|
$
|
(19,997
|
)
|
|||||
Akcea’s net loss attributable to our ownership
|
$
|
(19,997
|
)
|
|||||||||
Ionis’ stand-alone net income
|
18,785
|
|||||||||||
Net loss available to Ionis common stockholders
|
$
|
(1,212
|
)
|
|||||||||
Weighted average shares outstanding
|
125,330
|
|||||||||||
Basic net loss per share
|
$
|
(0.01
|
)
|
Three months ended March 31, 2019
|
Income
(Numerator)
|
Shares
(Denominator)
|
Per-Share
Amount
|
|||||||||
Net income available to Ionis common stockholders
|
$
|
87,543
|
138,582
|
$
|
0.63
|
|||||||
Effect of dilutive securities:
|
||||||||||||
Shares issuable upon exercise of stock options
|
—
|
2,252
|
||||||||||
Shares issuable upon restricted stock award issuance
|
—
|
665
|
||||||||||
Shares issuable related to our ESPP
|
—
|
38
|
||||||||||
Income available to Ionis common stockholders
|
$
|
87,543
|
141,537
|
$
|
0.62
|
● |
1 percent convertible senior notes;
|
● |
Dilutive stock options;
|
● |
Unvested restricted stock units; and
|
● |
Employee Stock Purchase Plan, or ESPP.
|
Three Months Ended
March 31,
|
|||||
2019
|
2018
|
||||
Risk-free interest rate
|
2.4%
|
2.2%
|
|||
Dividend yield
|
0.0%
|
0.0%
|
|||
Volatility
|
60.3%
|
63.2%
|
|||
Expected life
|
4.6 years
|
4.6 years
|
Three Months Ended
March 31,
|
|||||
2019
|
2018
|
||||
Risk-free interest rate
|
2.5%
|
1.6%
|
|||
Dividend yield
|
0.0%
|
0.0%
|
|||
Volatility
|
45.5%
|
44.4%
|
|||
Expected life
|
6 months
|
6 months
|
Three Months Ended
March 31,
|
|||||
2019
|
2018
|
||||
Risk-free interest rate
|
2.5%
|
2.6%
|
|||
Dividend yield
|
—
|
—
|
|||
Volatility
|
76.4%
|
77.1%
|
|||
Expected life
|
6.1 years
|
6.1 years
|
Three Months Ended
March 31,
|
|||||
2019
|
2018
|
||||
Risk-free interest rate
|
2.5%
|
1.6%
|
|||
Dividend yield
|
—
|
—
|
|||
Volatility
|
64.1%
|
62.3%
|
|||
Expected life
|
6 months
|
6 months
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Cost of products sold
|
$
|
118
|
$
|
—
|
||||
Research, development and patent
|
24,435
|
19,682
|
||||||
Selling, general and administrative
|
20,952
|
8,769
|
||||||
Total
|
$
|
45,505
|
$
|
28,451
|
1) |
When a participant is considered a customer in a collaborative arrangement, all of the associated accounting under Topic 606 should be applied
|
● |
We will apply all of the associated accounting under Topic 606 when we determine a participant in a collaborative arrangement is a
customer
|
2) |
Adds “unit of account” concept to collaboration accounting guidance to align with Topic 606. The “unit of account” concept is used to determine if revenue is
recognized or if a contra expense is recognized from consideration received under a collaboration
|
● |
We will use the “unit of account” concept when we receive consideration under a collaboration to determine when we recognize revenue or a
contra expense
|
3) |
The clarifying guidance precludes us from recognizing revenue under Topic 606 when we determine a transaction with a collaborative partner is not a customer
and is not directly related to the sales to third parties
|
● |
When we conclude a collaboration partner is not a customer and is not directly related to the sales to third parties, we will not
recognize revenue for the transaction
|
One year or less
|
74%
|
After one year but within two years
|
21%
|
After two years but within three years
|
5%
|
Total
|
100%
|
Gross Unrealized
|
||||||||||||||||
March 31, 2019
|
Cost (1)
|
Gains
|
Losses
|
Estimated Fair Value
|
||||||||||||
Available-for-sale securities:
|
||||||||||||||||
Corporate debt securities (2)
|
$
|
869,483
|
$
|
326
|
$
|
(531
|
)
|
$
|
869,278
|
|||||||
Debt securities issued by U.S. government agencies
|
124,744
|
71
|
(15
|
)
|
124,800
|
|||||||||||
Debt securities issued by the U.S. Treasury (2)
|
328,340
|
110
|
(12
|
)
|
328,438
|
|||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states
|
63,366
|
10
|
(203
|
)
|
63,173
|
|||||||||||
Other municipal debt securities
|
2,931
|
1
|
—
|
2,932
|
||||||||||||
Total securities with a maturity of one year or less
|
1,388,864
|
518
|
(761
|
)
|
1,388,621
|
|||||||||||
Corporate debt securities
|
360,976
|
1,236
|
(336
|
)
|
361,876
|
|||||||||||
Debt securities issued by U.S. government agencies
|
120,341
|
279
|
(112
|
)
|
120,508
|
|||||||||||
Debt securities issued by the U.S. Treasury
|
33,569
|
12
|
(22
|
)
|
33,559
|
|||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states
|
15,615
|
—
|
(125
|
)
|
15,490
|
|||||||||||
Total securities with a maturity of more than one year
|
530,501
|
1,527
|
(595
|
)
|
531,433
|
|||||||||||
Total available-for-sale securities
|
$
|
1,919,365
|
$
|
2,045
|
$
|
(1,356
|
)
|
$
|
1,920,054
|
|||||||
Equity securities:
|
||||||||||||||||
Total equity securities included in other current assets (3)
|
$
|
1,212
|
$
|
—
|
$
|
(244
|
)
|
$
|
968
|
|||||||
Total available-for-sale and equity securities
|
$
|
1,920,577
|
$
|
2,045
|
$
|
(1,600
|
)
|
$
|
1,921,022
|
Gross Unrealized
|
||||||||||||||||
December 31, 2018
|
Cost (1)
|
Gains
|
Losses
|
Estimated Fair Value
|
||||||||||||
Available-for-sale securities:
|
||||||||||||||||
Corporate debt securities
|
$
|
956,879
|
$
|
13
|
$
|
(1,858
|
)
|
$
|
955,034
|
|||||||
Debt securities issued by U.S. government agencies
|
168,839
|
3
|
(104
|
)
|
168,738
|
|||||||||||
Debt securities issued by the U.S. Treasury
|
244,640
|
15
|
(77
|
)
|
244,578
|
|||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states (2)
|
63,572
|
—
|
(323
|
)
|
63,249
|
|||||||||||
Total securities with a maturity of one year or less
|
1,433,930
|
31
|
(2,362
|
)
|
1,431,599
|
|||||||||||
Corporate debt securities
|
299,018
|
194
|
(1,286
|
)
|
297,926
|
|||||||||||
Debt securities issued by U.S. government agencies
|
107,789
|
194
|
(109
|
)
|
107,874
|
|||||||||||
Debt securities issued by the U.S. Treasury
|
15,600
|
—
|
(24
|
)
|
15,576
|
|||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states
|
16,980
|
—
|
(287
|
)
|
16,693
|
|||||||||||
Total securities with a maturity of more than one year
|
439,387
|
388
|
(1,706
|
)
|
438,069
|
|||||||||||
Total available-for-sale securities
|
$
|
1,873,317
|
$
|
419
|
$
|
(4,068
|
)
|
$
|
1,869,668
|
|||||||
Equity securities:
|
||||||||||||||||
Total equity securities included in other current assets (3)
|
1,212
|
137
|
—
|
1,349
|
||||||||||||
Total available-for-sale and equity securities
|
$
|
1,874,529
|
$
|
556
|
$
|
(4,068
|
)
|
$
|
1,871,017
|
(1) |
Our available-for-sale securities are held at amortized cost.
|
(2) |
Includes investments classified as cash equivalents on our condensed consolidated balance sheet.
|
(3) |
We recognize our equity securities at 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 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
|
275
|
$
|
530,786
|
$
|
(306
|
)
|
$
|
102,815
|
$
|
(561
|
)
|
$
|
633,601
|
$
|
(867
|
)
|
||||||||||||
Debt securities issued by U.S. government agencies
|
24
|
91,005
|
(81
|
)
|
16,534
|
(46
|
)
|
107,539
|
(127
|
)
|
||||||||||||||||||
Debt securities issued by the U.S. Treasury
|
15
|
94,603
|
(34
|
)
|
—
|
—
|
94,603
|
(34
|
)
|
|||||||||||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states
|
39
|
11,254
|
(9
|
)
|
51,579
|
(319
|
)
|
62,833
|
(328
|
)
|
||||||||||||||||||
Total temporarily impaired securities
|
353
|
$
|
727,648
|
$
|
(430
|
)
|
$
|
170,928
|
$
|
(926
|
)
|
$
|
898,576
|
$
|
(1,356
|
)
|
At
March 31, 2019
|
Quoted Prices in
Active Markets
(Level 1)
|
Significant Other
Observable Inputs
(Level 2)
|
Significant Unobservable Inputs
(Level 3)
|
|||||||||||||
Cash equivalents (1)
|
$
|
146,542
|
$
|
146,542
|
$
|
—
|
$
|
—
|
||||||||
Corporate debt securities (2)
|
1,231,154
|
—
|
1,231,154
|
—
|
||||||||||||
Debt securities issued by U.S. government agencies (3)
|
245,308
|
—
|
245,308
|
—
|
||||||||||||
Debt securities issued by the U.S. Treasury (4)
|
361,997
|
361,997
|
—
|
—
|
||||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states (3)
|
78,663
|
—
|
78,663
|
—
|
||||||||||||
Other municipal debt securities (3)
|
2,932
|
—
|
2,932
|
—
|
||||||||||||
Investment in ProQR Therapeutics N.V. (5)
|
968
|
—
|
—
|
968
|
||||||||||||
Total
|
$
|
2,067,564
|
$
|
508,539
|
$
|
1,558,057
|
$
|
968
|
At
December 31, 2018
|
Quoted Prices in
Active Markets
(Level 1)
|
Significant Other
Observable Inputs
(Level 2)
|
Significant Unobservable Inputs
(Level 3)
|
|||||||||||||
Cash equivalents (1)
|
$
|
146,281
|
$
|
146,281
|
$
|
—
|
$
|
—
|
||||||||
Corporate debt securities (6)
|
1,252,960
|
—
|
1,252,960
|
—
|
||||||||||||
Debt securities issued by U.S. government agencies (3)
|
276,612
|
—
|
276,612
|
—
|
||||||||||||
Debt securities issued by the U.S. Treasury (7)
|
260,154
|
260,154
|
—
|
—
|
||||||||||||
Debt securities issued by states of the U.S. and political subdivisions of the states (3)
|
79,942
|
—
|
79,942
|
—
|
||||||||||||
Investment in ProQR Therapeutics N.V. (5)
|
1,349
|
—
|
—
|
1,349
|
||||||||||||
Total
|
$
|
2,017,298
|
$
|
406,435
|
$
|
1,609,514
|
$
|
1,349
|
(1) |
Included in cash and cash equivalents on our condensed consolidated balance sheet.
|
(3) |
Included in short-term investments on our condensed consolidated balance sheet.
|
(4) |
$15.0 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.
|
(5) |
Included in other current assets on our condensed consolidated balance sheet.
|
(6) |
$50.2 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.
|
(7) |
$14.2 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.
|
At March 31, 2019
|
||||
Right-of-use operating lease assets (1)
|
$
|
13.1
|
||
Operating lease liabilities (2)
|
$
|
18.0
|
||
Weighted average remaining lease term
|
9 years
|
|||
Weighted average discount rate
|
7.6
|
%
|
(1) |
Included in deposits and other assets on our condensed consolidated balance sheet.
|
(2) |
Current portion of $2.0 million was included in current portion of long-term obligations on our condensed consolidated balance sheet, with the difference
included in long-term obligations.
|
Operating Leases
|
||||
Remainder of 2019
|
$
|
2,341
|
||
Years ending December 31,
|
||||
2020
|
3,008
|
|||
2021
|
2,725
|
|||
2022
|
2,539
|
|||
2023
|
2,505
|
|||
Thereafter
|
11,862
|
|||
Total minimum lease payments
|
24,980
|
|||
Less:
|
||||
Imputed interest
|
(7,020
|
)
|
||
Total operating lease liabilities
|
$
|
17,960
|
|
Three Months Ended
March 31,
|
|||||||
|
2019
|
2018
|
||||||
SPINRAZA royalties (commercial revenue)
|
$
|
59.7
|
$
|
41.1
|
||||
R&D revenue
|
24.5
|
10.8
|
||||||
Total revenue from our relationship with Biogen
|
$
|
84.2
|
$
|
51.9
|
||||
Percentage of total revenue
|
28
|
%
|
36
|
%
|
|
Three Months Ended
March 31,
|
|||||||
|
2019
|
2018
|
||||||
R&D revenue
|
$
|
41.2
|
$
|
2.0
|
||||
Percentage of total revenue
|
14
|
%
|
1
|
%
|
|
Three Months Ended
March 31,
|
|||||||
|
2019
|
2018
|
||||||
R&D revenue
|
$
|
157.1
|
$
|
17.1
|
||||
Percentage of total revenue
|
53
|
%
|
12
|
%
|
Three Months Ended March 31, 2019
|
Ionis Core
|
Akcea Therapeutics
|
Elimination of
Intercompany Activity
|
Total
|
||||||||||||
Revenue:
|
||||||||||||||||
Commercial revenue:
|
||||||||||||||||
SPINRAZA royalties
|
$
|
59,711
|
$
|
—
|
$
|
—
|
$
|
59,711
|
||||||||
TEGSEDI product sales, net
|
—
|
6,754
|
—
|
6,754
|
||||||||||||
Licensing and other royalty revenue
|
1,623
|
—
|
—
|
1,623
|
||||||||||||
Total commercial revenue
|
$
|
61,334
|
$
|
6,754
|
$
|
—
|
$
|
68,088
|
||||||||
R&D revenue under collaborative agreements
|
$
|
160,556
|
$
|
157,062
|
$
|
(88,492
|
)
|
$
|
229,126
|
|||||||
Total segment revenue
|
$
|
221,890
|
$
|
163,816
|
$
|
(88,492
|
)
|
$
|
297,214
|
|||||||
Total operating expenses
|
$
|
114,515
|
$
|
137,610
|
$
|
(76,446
|
)
|
$
|
175,679
|
|||||||
Income from operations
|
$
|
107,375
|
$
|
26,206
|
$
|
(12,046
|
)
|
$
|
121,535
|
Three Months Ended March 31, 2018
|
Ionis Core
|
Akcea Therapeutics
|
Elimination of
Intercompany Activity
|
Total
|
||||||||||||
Revenue:
|
||||||||||||||||
Commercial revenue:
|
||||||||||||||||
SPINRAZA royalties
|
$
|
41,081
|
$
|
—
|
$
|
—
|
$
|
41,081
|
||||||||
Licensing and other royalty revenue
|
942
|
—
|
—
|
942
|
||||||||||||
Total commercial revenue
|
$
|
42,023
|
$
|
—
|
$
|
—
|
$
|
42,023
|
||||||||
R&D revenue under collaborative agreements
|
$
|
90,517
|
$
|
17,108
|
$
|
(5,229
|
)
|
$
|
102,396
|
|||||||
Total segment revenue
|
$
|
132,540
|
$
|
17,108
|
$
|
(5,229
|
)
|
$
|
144,419
|
|||||||
Total operating expense
|
$
|
105,544
|
$
|
47,435
|
$
|
(5,259
|
)
|
$
|
147,720
|
|||||||
Income (loss) from operations
|
$
|
26,996
|
$
|
(30,327
|
)
|
$
|
30
|
$
|
(3,301
|
)
|
Total Assets
|
Ionis Core
|
Akcea Therapeutics
|
Elimination of
Intercompany Activity
|
Total
|
||||||||||||
March 31, 2019
|
$
|
3,112,235
|
$
|
458,717
|
$
|
(735,063
|
)
|
$
|
2,835,889
|
|||||||
December 31, 2018
|
$
|
2,975,491
|
$
|
365,261
|
$
|
(672,968
|
)
|
$
|
2,667,784
|
ITEM 2 |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
Three Months Ended March 31,
|
||||||||
2019
|
2018
|
|||||||
Total revenue
|
$
|
297,214
|
$
|
144,419
|
||||
Total operating expenses
|
$
|
175,679
|
$
|
147,720
|
||||
Income (loss) from operations
|
$
|
121,535
|
$
|
(3,301
|
)
|
|||
Net income (loss)
|
$
|
90,884
|
$
|
(10,812
|
)
|
|||
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders
|
$
|
84,443
|
$
|
(1,420
|
)
|
● |
SPINRAZA – the worldwide standard-of-care for the treatment
of people with all forms of spinal muscular atrophy
|
o |
Biogen reported worldwide sales of SPINRAZA of $518 million in the first quarter of 2019, a 42 percent increase compared to Q1 2018, driven primarily by
increased penetration in existing markets, new country launches and continued uptake in the U.S. by children and adult patients.
|
o |
There were more than 7,500 SMA patients from over 40 countries on SPINRAZA treatment at the end of the first quarter of 2019, including commercial patients
and patients in the expanded access program and clinical trials.
|
o |
SPINRAZA data from the ongoing NURTURE and SHINE open-label extension studies demonstrated continued durable efficacy and reinforced the safety profile of
SPINRAZA in patients treated for up to 6 years, as presented by Biogen at the 2019 AAN Annual Meeting.
|
● |
TEGSEDI – launch underway in multiple markets for the
treatment of polyneuropathy of hATTR in adult patients
|
o |
TEGSEDI product sales were $7 million in its first full quarter on the market and $9 million since launching in Q4 2018.
|
o |
TEGSEDI received a positive Final Evaluation Document, or FED, from the National Institute for Health and Care Excellence, or NICE, authorizing reimbursement
for the treatment of patients with polyneuropathy due to hATTR amyloidosis in England.
|
o |
Data presented at AAN from the TEGSEDI NEURO-TTR open-label extension study demonstrated long-term efficacy and safety in patients with hATTR.
|
● |
WAYLIVRA – approved in the EU for the treatment of adults
with genetically confirmed FCS at high risk for pancreatitis
|
o |
Akcea’s preparations to launch in the EU are underway, beginning in Germany in Q3 2019.
|
o |
Launch in additional EU countries is planned in 2020.
|
o |
Earned a $6 million milestone payment from PTC Therapeutics for the EU approval of WAYLIVRA.
|
● |
Roche presented nine-month data from the ongoing Phase 1/2 open-label extension study of IONIS-HTTRx in patients with Huntington’s disease at AAN,
demonstrating continued and sustained reductions in mutant huntingtin protein with bi-monthly dosing.
|
o |
Based on these data, Roche amended the dosing regimen in the Phase 3 study of IONIS-HTTRx in patients with Huntington’s disease to replace the
monthly dosing regimen with a tri-annual (every four months) dosing regimen.
|
● |
Biogen presented data from the Phase 1/2 study of tofersen in SOD1-ALS patients at AAN, demonstrating improvements in clinical measures of ALS disease
progression after three months of treatment.
|
o |
Biogen is collaborating with regulators to further define the scope of the clinical data package required to support registration.
|
● |
We generated a $7.5 million milestone payment for advancing a new target for an unidentified neurological disease under our 2018 strategic neurology
collaboration with Biogen.
|
● |
Brett P. Monia, Ph.D., our chief operating officer was appointed to our board of directors.
|
● |
Assessing the propriety of revenue recognition and associated deferred revenue;
|
● |
Valuing premiums received under our collaborations;
|
● |
Determining the proper valuation of investments in marketable securities;
|
● |
Determining the appropriate cost estimates for unbilled preclinical studies and clinical development activities; and
|
● |
Accounting for income taxes.
|
|
Three Months Ended
March 31,
|
|||||||
|
2019
|
2018
|
||||||
Revenue:
|
||||||||
Commercial revenue:
|
||||||||
SPINRAZA royalties
|
$
|
59,711
|
$
|
41,081
|
||||
TEGSEDI product sales, net
|
6,754
|
—
|
||||||
Licensing and other royalty revenue
|
1,623
|
942
|
||||||
Total commercial revenue
|
68,088
|
42,023
|
||||||
R&D revenue:
|
||||||||
Amortization from upfront payments
|
35,851
|
28,011
|
||||||
Milestone payments
|
40,017
|
6,329
|
||||||
License fees
|
150,000
|
61,678
|
||||||
Other services
|
3,258
|
6,378
|
||||||
Total R&D revenue
|
229,126
|
102,396
|
||||||
Total revenue
|
$
|
297,214
|
$
|
144,419
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Ionis Core
|
$
|
78,514
|
$
|
83,476
|
||||
Akcea Therapeutics
|
128,106
|
41,052
|
||||||
Elimination of intercompany activity
|
(76,446
|
)
|
(5,259
|
)
|
||||
Subtotal
|
130,174
|
119,269
|
||||||
Non-cash compensation expense related to equity awards
|
45,505
|
28,451
|
||||||
Total operating expenses
|
$
|
175,679
|
$
|
147,720
|
Three Months Ended
March 31,
|
||||
2019
|
||||
Ionis Core
|
$
|
—
|
||
Akcea Therapeutics
|
2,326
|
|||
Elimination of intercompany activity
|
(1,403
|
)
|
||
Subtotal
|
923
|
|||
Non-cash compensation expense related to equity awards
|
118
|
|||
Total cost of products sold
|
$
|
1,041
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Research, development and patent expenses, excluding non-cash compensation expense related to
equity awards
|
$
|
81,982
|
$
|
84,385
|
||||
Non-cash compensation expense related to equity awards
|
24,435
|
19,682
|
||||||
Total research, development and patent expenses
|
$
|
106,417
|
$
|
104,067
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Ionis Core
|
$
|
61,327
|
$
|
63,988
|
||||
Akcea Therapeutics
|
95,698
|
25,657
|
||||||
Elimination of intercompany activity
|
(75,043
|
)
|
(5,259
|
)
|
||||
Subtotal
|
81,982
|
84,386
|
||||||
Non-cash compensation expense related to equity awards
|
24,435
|
19,682
|
||||||
Total research, development and patent expenses
|
$
|
106,417
|
$
|
104,068
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Antisense drug discovery expenses, excluding non-cash compensation expense related to equity awards
|
$
|
14,632
|
$
|
13,905
|
||||
Non-cash compensation expense related to equity awards
|
5,493
|
4,376
|
||||||
Total antisense drug discovery expenses
|
$
|
20,125
|
$
|
18,281
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
WAYLIVRA
|
$
|
1,971
|
$
|
6,401
|
||||
TEGSEDI
|
4,691
|
5,836
|
||||||
Other antisense development projects
|
22,310
|
20,653
|
||||||
Development overhead expenses
|
18,944
|
17,110
|
||||||
Total antisense drug development, excluding non-cash compensation expense related to equity awards
|
47,916
|
50,000
|
||||||
Non-cash compensation expense related to equity awards
|
12,234
|
8,858
|
||||||
Total antisense drug development expenses
|
$
|
60,150
|
$
|
58,858
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Ionis Core
|
$
|
29,070
|
$
|
30,972
|
||||
Akcea Therapeutics
|
93,846
|
19,028
|
||||||
Elimination of intercompany activity
|
(75,000
|
)
|
—
|
|||||
Subtotal
|
47,916
|
50,000
|
||||||
Non-cash compensation expense related to equity awards
|
12,234
|
8,858
|
||||||
Total antisense drug development expenses
|
$
|
60,150
|
$
|
58,858
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Manufacturing and operations expenses, excluding non-cash compensation expense related to equity
awards
|
$
|
10,154
|
$
|
12,309
|
||||
Non-cash compensation expense related to equity awards
|
2,057
|
2,402
|
||||||
Total manufacturing and operations expenses
|
$
|
12,211
|
$
|
14,711
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Ionis Core
|
$
|
8,799
|
$
|
11,642
|
||||
Akcea Therapeutics
|
1,355
|
5,896
|
||||||
Elimination of intercompany activity
|
—
|
(5,229
|
)
|
|||||
Subtotal
|
10,154
|
12,309
|
||||||
Non-cash compensation expense related to equity awards
|
2,057
|
2,402
|
||||||
Total manufacturing and operations expenses
|
$
|
12,211
|
$
|
14,711
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Personnel costs
|
$
|
3,910
|
$
|
3,103
|
||||
Occupancy
|
2,177
|
1,759
|
||||||
Patent expenses
|
523
|
701
|
||||||
Depreciation and amortization
|
121
|
101
|
||||||
Insurance
|
411
|
470
|
||||||
Other
|
2,138
|
2,038
|
||||||
Total R&D support expenses, excluding non-cash compensation expense related to equity awards
|
9,280
|
8,172
|
||||||
Non-cash compensation expense related to equity awards
|
4,651
|
4,046
|
||||||
Total R&D support expenses
|
$
|
13,931
|
$
|
12,218
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Ionis Core
|
$
|
8,826
|
$
|
7,470
|
||||
Akcea Therapeutics
|
497
|
732
|
||||||
Elimination of intercompany activity
|
(43
|
)
|
(30
|
)
|
||||
Subtotal
|
9,280
|
8,172
|
||||||
Non-cash compensation expense related to equity awards
|
4,651
|
4,046
|
||||||
Total R&D support expenses
|
$
|
13,931
|
$
|
12,218
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Selling, general and administrative expenses, excluding non-cash compensation expense related to
equity awards
|
$
|
47,269
|
$
|
34,884
|
||||
Non-cash compensation expense related to equity awards
|
20,952
|
8,769
|
||||||
Total selling, general and administrative expenses
|
$
|
68,221
|
$
|
43,653
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Ionis Core
|
$
|
17,187
|
$
|
19,488
|
||||
Akcea Therapeutics
|
30,082
|
15,396
|
||||||
Subtotal
|
47,269
|
34,884
|
||||||
Non-cash compensation expense related to equity awards
|
20,952
|
8,769
|
||||||
Total selling, general and administrative expenses
|
$
|
68,221
|
$
|
43,653
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Cost of products sold
|
$
|
2,326
|
$
|
—
|
||||
Development and patent expenses
|
95,698
|
25,656
|
||||||
Selling, general and administrative expenses
|
30,082
|
15,396
|
||||||
Profit/loss share for TEGSEDI commercialization activities
|
(9,056
|
)
|
—
|
|||||
Total operating expenses, excluding non-cash compensation expense related to equity awards
|
119,050
|
41,052
|
||||||
Non-cash compensation expense related to equity awards
|
18,560
|
6,383
|
||||||
Total Akcea Therapeutics operating expenses
|
$
|
137,610
|
$
|
47,435
|
Three Months Ended
March 31,
|
||||||||
2019
|
2018
|
|||||||
Convertible notes:
|
||||||||
Non-cash amortization of the debt discount and debt issuance costs
|
$
|
9,200
|
$
|
8,524
|
||||
Interest expense payable in cash
|
1,714
|
1,714
|
||||||
Interest on mortgage for primary R&D and manufacturing facilities
|
582
|
594
|
||||||
Other
|
103
|
106
|
||||||
Total interest expense
|
$
|
11,599
|
$
|
10,938
|
|
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)
|
$
|
706.0
|
$
|
6.9
|
$
|
699.1
|
$
|
—
|
$
|
—
|
||||||||||
Building mortgage payments
|
80.2
|
2.4
|
4.8
|
6.4
|
66.6
|
|||||||||||||||
Financing arrangements (principal and interest payable)
|
12.7
|
12.7
|
—
|
—
|
—
|
|||||||||||||||
Other obligations (principal and interest payable)
|
1.0
|
0.1
|
0.1
|
0.1
|
0.7
|
|||||||||||||||
Operating leases
|
25.3
|
3.2
|
5.8
|
5.1
|
11.2
|
|||||||||||||||
Total
|
$
|
825.2
|
$
|
25.3
|
$
|
709.8
|
$
|
11.6
|
$
|
78.5
|
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 medicines and their potential advantages over competing
products;
|
● |
cost and effectiveness of our medicines compared to other available therapies;
|
● |
patient convenience of the dosing regimen for our medicines; and
|
● |
reimbursement policies of government and third-party payors.
|
● |
priced lower than our medicines;
|
● |
reimbursed more favorably by government and other third-party payors than our medicines;
|
● |
safer than our medicines;
|
● |
more effective than our medicines; or
|
● |
more convenient to use than our medicines.
|
● |
In the U.S., TEGSEDI’s label contains a boxed warning for thrombocytopenia and glomerulonephritis;
|
● |
TEGSEDI requires periodic blood and urine monitoring; and
|
● |
in the U.S. 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 medicine 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 medicines 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 medicines.
|
● |
pursue alternative technologies or develop alternative products that may be competitive with the medicine 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 medicines than it does for its own medicines.
|
● |
successful commercialization for SPINRAZA, TEGSEDI and WAYLIVRA;
|
● |
additional marketing approvals for WAYLIVRA and TEGSEDI;
|
● |
the profile and launch timing of our medicines, including TEGSEDI and WAYLIVRA;
|
● |
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
|
|
Amended and Restated Strategic Advisory Services Agreement by and between the Registrant and B. Lynne Parshall, dated March 22,
2019. – Filed as an exhibit to the Registrant’s Current Report on Form 8-K filed March 26, 2019 and incorporated herein by reference.
|
||
Registrant’s Amended and Restated 2000 Employee Stock Purchase Plan. – Filed as an exhibit to the Registrant’s Current Report on Form
8-K filed March 26, 2019 and incorporated herein by reference.
|
||
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.
|
||
32.1*
|
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 March 31,
2019, 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 stockholders' equity, (v) condensed consolidated statements of cash flows and (vi) 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)
|
May 9, 2019
|
||
/s/ ELIZABETH L. HOUGEN
|
Senior Vice President, Finance and Chief Financial Officer
|
|||
Elizabeth L. Hougen
|
(Principal financial and accounting officer)
|
May 9, 2019
|
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: May 9, 2019 | |
/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: May 9, 2019 | |
/s/ ELIZABETH L. HOUGEN | |
Elizabeth L. Hougen | |
Chief Financial Officer |
1. | The Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2019, 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: May 9, 2019 | ||
/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 |
3 Months Ended | |
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Mar. 31, 2019 |
May 02, 2019 |
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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 | 140,322,994 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 |
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares |
Mar. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
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) | 139,623,937 | 137,928,828 |
Common stock, shares outstanding (in shares) | 139,623,937 | 137,928,828 |
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 | |
---|---|---|
Mar. 31, 2019 |
Mar. 31, 2018 |
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CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) [Abstract] | ||
Net income (loss) | $ 90,884 | $ (10,812) |
Unrealized gains (losses) on debt securities, net of tax | 4,324 | (1,530) |
Currency translation adjustment | 84 | 55 |
Comprehensive income (loss) | 95,292 | (12,287) |
Comprehensive (income) loss attributable to noncontrolling interests | 6,442 | (9,399) |
Comprehensive income (loss) attributable to Ionis Pharmaceuticals, Inc. stockholders | $ 88,850 | $ (2,888) |
Basis of Presentation |
3 Months Ended |
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Mar. 31, 2019 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | 1. Basis of Presentation We prepared the unaudited interim condensed consolidated financial statements for the three months ended March 31, 2019 and 2018 on the same basis as the audited financial statements for the year ended December 31, 2018. 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, 2018 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. We formed Akcea in December 2014. In July 2017, Akcea completed an initial public offering, or IPO, and therefore, beginning in July 2017, we no longer owned 100 percent of Akcea. In the first quarter of 2019, we received 2.8 million shares of Akcea common stock as payment for the sublicense fee Akcea owed us when Novartis licensed AKCEA-APO(a)-LRx, increasing our ownership to approximately 76 percent at March 31, 2019. We reflected the increase in our ownership in these financial statements. 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 |
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Significant Accounting Policies | 2. Significant Accounting Policies Revenue Recognition 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 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 will also recognize as commercial revenue future sales milestone payments and royalties we earn under our partnerships. Commercial Revenue: TEGSEDI Product Sales, net We added product sales from TEGSEDI to our commercial revenue in the fourth quarter of 2018. In the U.S., TEGSEDI is distributed through an exclusive distribution agreement with a third-party logistics company, or 3PL, that takes title to TEGSEDI. The 3PL is our sole customer in the U.S. The 3PL then distributes TEGSEDI to a specialty pharmacy and a specialty distributor, which we collectively refer to as wholesalers, who then distribute TEGSEDI to health care providers and patients. In Germany, TEGSEDI is distributed through a non-exclusive distribution model with a 3PL that takes title to TEGSEDI. The 3PL is our sole customer in Germany. The 3PL in Germany then distributes TEGSEDI to hospitals and pharmacies. 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. We provide details about our collaboration agreements in Note 7, Collaborative Arrangements and Licensing Agreements, in our Annual Report on Form 10-K for the year ended December 31, 2018. 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 we enter into a collaboration agreement in which we provide our partner with an option to license a medicine 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 medicine 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 medicine 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 and are contingent on certain events. 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 and are usually based on scientific progress. For example, in the first quarter of 2019, we earned $35 million in milestone payments from Roche when it dosed the first patient in the Phase 3 study of IONIS-HTTRx (RG6042) because we do not have any performance obligations related to these milestone payments as Roche is conducting the Phase 3 study of IONIS-HTTRx. At December 31, 2018, we determined it was not probable that we could earn these milestone payments. As such, we did not recognize any revenue associated with the milestone payments in 2018.
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. Commercial Revenue: TEGSEDI Product Sales, net We recognize TEGSEDI product sales in the period when our customer obtains control of TEGSEDI, which occurs at a point in time upon transfer of title to the customer. We classify payments to customers or other parties in the distribution channel for services that are distinct and priced at fair value as selling, general and administrative expenses in our condensed consolidated statements of operations. Otherwise payments to customers or other parties in the distribution channel that do not meet those criteria are classified as a reduction of revenue, as discussed further below. We exclude from revenues, taxes collected from customers relating to product sales and remitted to governmental authorities. Reserves for TEGSEDI Product Sales We record TEGSEDI product sales at our net sales price, or transaction price. We include in our transaction price estimated reserves for discounts, returns, chargebacks, rebates, co-pay assistance and other allowances that we offer within contracts between us and our customers, wholesalers, health care providers and other indirect customers. We estimate our reserves using the amounts we have earned or what we can claim on the associated sales. We classify our reserves as reductions of accounts receivable when the amount is payable to our customer or a current liability when the amount is payable to a party other than our customer in our condensed consolidated balance sheet. In certain cases, our estimates include a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, our reserves reflect our best estimates under the terms of our respective contracts. When calculating our reserves and related product sales, we only recognize amounts to the extent that we consider it probable that we would not have to reverse in a future period a significant amount of the cumulative sales we previously recognized. The actual amounts we receive may ultimately differ from our reserve estimates. If actual amounts in the future vary from our estimates, we will adjust these estimates, which would affect our net TEGSEDI product sales in the respective period. The following are the components of variable consideration related to TEGSEDI product sales: Chargebacks: In the U.S., we estimate obligations resulting from contractual commitments with the government and other entities to sell products to qualified healthcare providers at prices lower than the list prices charged to our U.S. customer. Our U.S. customer charges us for the difference between what it pays for the product and the selling price to the qualified healthcare providers. We record reserves for these chargebacks related to TEGSEDI product sales to our U.S. customer during the reporting period. We also estimate the amount of product remaining in the distribution channel at the end of the reporting period that we expect our customer to sell to healthcare providers in future periods. Government rebates: We are subject to discount obligations under government programs, including Medicaid programs and Medicare in the U.S. and we record reserves for government rebates based on statutory discount rates and estimated utilization. We estimate Medicaid and Medicare rebates based on a range of possible outcomes that are probability-weighted for the estimated payer mix. We record these reserves as an accrued liability on our condensed consolidated balance sheet with a corresponding offset reducing our TEGSEDI product sales in the same period we recognize the related sale. For Medicare, we also estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. On a quarterly basis, we update our estimates and record any adjustments in the period that we identify the adjustments. Trade discounts and allowances: We provide customary invoice discounts on TEGSEDI product sales to our U.S. customer for prompt payment. We record this discount as a reduction of TEGSEDI product sales in the period in which we recognize the related product revenue. In addition, we receive and pay for various distribution services from our U.S. customer and wholesalers in our U.S. distribution channel. For services we receive that are either not distinct from the sale of TEGSEDI or for which we cannot reasonably estimate the fair value, we classify such fees as a reduction of TEGSEDI product sales. Product Returns: Our U.S. customer has return rights and the wholesalers have limited return rights primarily related to the TEGSEDI’s expiration date. We estimate the amount of TEGSEDI product sales that our customer may return. We record our return estimate as an accrued refund liability on our condensed consolidated balance sheet with a corresponding offset reducing our TEGSEDI product sales, in the same period we recognize the related sale. Based on our distribution model for TEGSEDI, contractual inventory limits with our customer and wholesalers and the price of TEGSEDI, we believe we will have minimal returns. Our customer in Germany only takes title to the product once it receives an order from a hospital or pharmacy and therefore does not maintain any inventory of TEGSEDI, as such we do not estimate returns in Germany. Other incentives: In the U.S., we estimate reserves for other incentives including co-payment assistance we provide to patients with commercial insurance who have coverage and reside in states that allow co-payment assistance. We record a reserve for the amount we estimate we will pay for co-payment assistance. We base our reserve on the number of estimated claims and our estimate of the cost per claim related to TEGSEDI product sales that we have recognized as revenue. We record our other incentive reserve estimates as an accrued liability on our condensed consolidated balance sheet with a corresponding offset reducing our TEGSEDI product sales, in the same period we recognize the related sale. 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 collaboration agreement with Roche to develop IONIS-FB-LRx for the treatment of complement-mediated diseases, we received a $75 million upfront payment in the fourth quarter of 2018. We allocated the upfront payment to our single performance obligation, R&D services. We are amortizing the $75 million upfront payment using an input method over the estimated period of time we are providing R&D services. Milestone Payments We are required to include additional consideration in the transaction price when it is probable. 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 medicine is approved by the applicable regulatory agency. 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. We added this payment to the transaction price and allocated it to our R&D services performance obligation. We are recognizing revenue from this milestone payment over our estimated period of performance. Conversely, we recognize in full those milestone payments that we earn based on our partners’ activities when our partner achieves the milestone event and we do not have a performance obligation. For example, in the first quarter of 2019, we recognized $35 million in milestone payments when Roche dosed the first patient in a Phase 3 study for IONIS-HTTRx. We concluded that the milestone payments were not related to our R&D services performance obligation. Therefore, we recognized these milestone payments in full in the first quarter of 2019. 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 first quarter of 2019, we earned a $150 million license fee when Novartis licensed AKCEA-APO(a)-LRx from us. 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 stand-alone 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 7, Collaborative Arrangements and Licensing Agreements, for further discussion of our accounting treatment for our Bayer collaboration. 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. Contracts Receivable Our contracts receivable balance represents the amounts we have billed our partners or customers and that are due to us unconditionally for goods we have delivered or services we have performed. When we bill our partners or customers 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 or customer. 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. Cost of Products Sold Our cost of products sold includes manufacturing costs, transportation and freight costs and indirect overhead costs associated with the manufacturing and distribution of TEGSEDI. We also may include certain period costs related to manufacturing services and inventory adjustments in cost of products sold. Prior to obtaining regulatory approval in July 2018, we expensed a significant portion of the costs we incurred to produce the TEGSEDI supply we are using in the commercial launch as research and development expense. We previously recognized $0.3 million of costs to produce TEGSEDI related to the TEGSEDI commercial revenue we recognized in the three months ended March 31, 2019. 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, third and fourth 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. In the first quarter of 2019, we received 2.8 million shares of Akcea common stock as payment for the sublicense fee Akcea owed us when Novartis licensed AKCEA-APO(a)-LRx, increasing our ownership to approximately 76 percent at March 31, 2019. We reflected this increase in our ownership percentage in these financial statements as an adjustment to noncontrolling interest. 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 condensed 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 March 31, 2019, we held equity investments in two publicly held companies, ProQR Therapeutics N.V., or ProQR, and 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. Inventory valuation We reflect our inventory on our condensed 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 medicines because until we use these raw materials they have alternative future uses. We include in inventory raw material costs for medicines 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 medicine. For example, if one of our medicines failed, we could use the raw materials for that medicine to manufacture our other medicines. We expense these costs as R&D expenses when we begin to manufacture API for a particular medicine if the medicine has not been approved for marketing by a regulatory agency. We obtained the first regulatory approval for TEGSEDI in July 2018. At March 31, 2019 and December 31, 2018, 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 medicines in development and historical write-offs. We did not record any inventory write-offs for the three months ended March 31, 2019 and 2018. Total inventory was $11.1 million and $8.6 million as of March 31, 2019 and December 31, 2018, respectively. Leases Topic 842 Adoption In February 2016, the FASB issued amended accounting guidance related to lease accounting. This guidance supersedes the lease requirements we previously followed in Accounting Standards Codification, or ASC, Topic 840, Leases, or Topic 840, and created a new lease accounting standard, Topic 842, Leases, or Topic 842. Under Topic 842, an entity will record on its balance sheet all leases with a term longer than one year. Further, an entity will record a liability with a value equal to the present value of payments it will make over the life of the lease (lease liability) and an asset representing the underlying leased asset (right-of-use asset). The new accounting guidance requires entities to determine if its leases are operating or financing leases. Entities will recognize expense for operating leases on a straight-line basis as an operating expense. If an entity determines a lease is a financing lease, it will record both interest and amortization expense and generally the expense will be higher in the earlier periods of the lease. We adopted Topic 842 on January 1, 2019 and adjusted our opening balance sheet on that date for our right-of-use operating lease assets and operating lease liabilities. At adoption, we recorded $13.5 million in right-of-use operating lease assets and $18.5 million in operating lease liabilities, of which we classified $2 million as a current liability. We adopted Topic 842 using the available practical expedients permitted under the transition guidance within the new standard, which among other things, allowed us to carry forward the historical lease classification of those leases we had in place as of January 1, 2019. The adoption did not have an impact on our condensed consolidated statement of operations. Leases We determine if an arrangement contains a lease at inception. We currently only have operating leases. We recognize a right-of-use operating lease asset and associated short- and long-term operating lease liability on our condensed consolidated balance sheet for operating leases greater than one year. Our right-of-use assets represent our right to use an underlying asset for the lease term and our lease liabilities represent our obligation to make lease payments arising from the lease arrangement. We recognize our right-of-use operating lease assets and lease liabilities based on the present value of the future minimum lease payments we will pay over the lease term. We determined the lease term at the commencement date of the lease, and in certain cases our lease term could include renewal options if we concluded we were reasonably certain that we will exercise the renewal option. As our current leases do not provide an interest rate implicit in the lease, we used our or Akcea’s incremental borrowing rate, based on the information available on the date we adopted Topic 842 in determining the present value of future payments. Our right-of-use operating lease asset also includes any lease payments we made and excludes any tenant improvement allowances we received. We recognize rent expense for our minimum lease payments on a straight-line basis over the expected term of our lease. We recognize period expenses, such as common area maintenance expenses, in the period we incur the expense. 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. Income Taxes We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in our financial statements or tax returns. In addition, deferred tax assets are recorded for the future benefit of utilizing net operating losses and research and development credit carryforwards. We record a valuation allowance when necessary to reduce our net deferred tax assets to the amount expected to be realized. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act of 2017, or the Tax Act. The Tax Act created a new requirement on global intangible low-taxed income, or GILTI, earned by foreign subsidiaries for tax years beginning on or after January 1, 2018. The GILTI provisions require foreign subsidiary earnings in excess of an allowable return on the foreign subsidiary’s assets to be included in our U.S. income tax return. Under U.S. GAAP, we are permitted to make an accounting policy election to either treat taxes due on future inclusions in U.S. taxable income related to GILTI as a current-period expense when incurred or to factor such amounts into our measurement of deferred taxes. We have made the election to account for GILTI as a component of current taxes incurred rather than as a component of deferred taxes. Long-lived assets We evaluate long-lived assets, which include property, plant and equipment, right-of-use operating lease assets 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 months ended March 31, 2019 and 2018 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 income per share for the three months ended March 31, 2019, was calculated as follows (in thousands, except per share amounts):
Our basic net loss per share for the three months ended March 31, 2018, was calculated as follows (in thousands, except per share amounts):
Dilutive net income (loss per share) For the three months ended March 31, 2019, 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 the period. We calculated our diluted net income per share for the three months ended March 31, 2019 as follows (in thousands except per share amounts):
For the three months ended March 31, 2019, the calculation excluded the 1 percent notes because the effect on diluted earnings per share was anti-dilutive. For the three months ended March 31, 2018, 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:
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 medicines 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 three months ended March 31, 2019 and 2018, we used the following weighted-average assumptions in our Black-Scholes calculations: Ionis Employee Stock Options:
Ionis 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 for the three months ended March 31, 2019 was $58.26 per share. In addition to our stock plans, Akcea has its own stock plan under which it grants options and RSUs and under which it derives its stock-based compensation expense. The following are the weighted-average Black-Scholes assumptions Akcea used under its plan for the three months ended March 31, 2019 and March 31, 2018: Akcea Employee Stock Options:
Akcea ESPP:
The following table summarizes stock-based compensation expense for the three months ended March 31, 2019 and 2018 (in thousands). Our non-cash stock-based compensation expense includes $18.6 million and $6.4 million of stock-based compensation expense for Akcea employees for the three months ended March 31, 2019 and 2018, respectively.
As of March 31, 2019, total unrecognized estimated non-cash stock-based compensation expense related to non-vested stock options and RSUs was $192.2 million and $68.7 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 1.4 years and 2.0 years, respectively. Impact of recently issued accounting standards 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 condensed consolidated financial statements and disclosures. 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 condensed 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 adopted this updated guidance on January 1, 2019 and it did not have a significant impact on our disclosures. In November 2018, the FASB issued clarifying guidance of the interaction between the collaboration accounting guidance and the new revenue recognition guidance we adopted on January 1, 2018 (Topic 606). Below is the clarifying guidance and how we will implement it (in italics):
The updated guidance is effective for public entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. We plan to adopt this guidance on January 1, 2020. We are currently assessing the effects it will have on our condensed consolidated financial statements and disclosures. |
Investments |
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Investments | 3. Investments As of March 31, 2019, 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 March 31, 2019:
As illustrated above, at March 31, 2019, 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 March 31, 2019, we had an ownership interest of less than 20 percent in four private companies and two public companies 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 companies are ProQR and ATL. 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 March 31, 2019. 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 | 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. The following tables present the major security types we held at March 31, 2019 and December 31, 2018 that we regularly measure and carry at fair value. At March 31, 2019 and December 31, 2018, our ProQR investment was subject to trading restrictions that extend through the fourth quarter of 2019, as a result we included a lack of marketability discount in valuing this investment, which is a Level 3 input. The amount we owned in ProQR did not change from December 31, 2018 to March 31, 2019. 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):
(2) $27.1 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.
Convertible Notes Our 1 percent notes had a fair value of $928.4 million at March 31, 2019. 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. |
Operating Leases |
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Operating Leases | 5. Operating Leases We lease a facility adjacent to our manufacturing facility that has laboratory and office space that we use to support our manufacturing facility. We lease this space under a non-cancelable operating lease with an initial term ending in June 2021 and an option to extend the lease for up to two five-year periods. We also lease additional office space and we sublease a portion of this space to Akcea. We lease this space under a non-cancelable operating lease with an initial term ending in June 2023 and an option to extend the lease for one five-year period. The sublease with Akcea is eliminated in our condensed consolidated financial statements. Akcea entered into an operating lease agreement for office space located in Boston, Massachusetts for its new corporate headquarters in the second quarter of 2018. The lease commencement date was in August 2018 and Akcea took occupancy in September 2018. Akcea is leasing this space under a non-cancelable operating lease with an initial term ending after 123 months and an option to extend the lease for an additional five-year term. Under the lease agreement, Akcea received a three-month free rent period, which commenced on August 15, 2018, and a tenant improvement allowance up to $3.8 million. Akcea provided the lessor with a letter of credit to secure its obligations under the lease in the initial amount of $2.4 million, to be reduced to $1.8 million on the third anniversary of the rent commencement date and to $1.2 million on the fifth anniversary of the rent commencement date if Akcea meets certain conditions set forth in the lease at each such time. When we determined our lease term for our operating lease right-of-use assets and lease liabilities for these leases we did not include the extension options for these leases. Amounts related to our operating leases were as follows (dollar amounts in millions):
We paid cash of $1.0 million for rent payments we made during the three months ended March 31, 2019, which was included in the measurement of our lease liabilities in our net cash provided by operating activities in our condensed consolidated statement of cash flows. As of March 31, 2019, the payments for our operating lease liabilities are as follows (in thousands):
Rent expense was $0.9 million for the three months ended March 31, 2019 and was negligible for the three months ended March 31, 2018. |
Income Taxes |
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Income Taxes [Abstract] | |
Income Taxes | 6. Income Taxes Our effective tax rate may vary from the U.S. federal statutory tax rate due to the change in the mix of earnings in tax jurisdictions with different statutory rates, benefits related to tax credits, and the tax impact of non-deductible expenses and other permanent differences between income before income taxes and taxable income. Our effective income tax rate of 25.5 percent for the three months ended March 31, 2019 differed from the U.S. federal statutory rate of 21 percent primarily due to state taxes, partially offset by the tax benefit related to estimated research & development and orphan drug credits and the excess tax benefit related to share-based compensation. We recorded income tax expense of $31 million for the three months ended March 31, 2019, compared to $15,000 for the same period in 2018. The increase in our income tax expense was primarily due to our expectation that we will generate U.S. federal and state taxable income in 2019. Our 2019 income tax expense has two components. The first component relates to federal income taxes. We expect to utilize our deferred tax assets to offset our U.S. federal taxable income. We are recording non-cash income tax expense as we utilize our federal deferred tax assets. The other component of our income tax expense relates to the estimated cash taxes we will pay for our state income taxes. Although we are recording the expense for our state income taxes in 2019, we will not have to make the majority of the payment for this liability until the first quarter of 2020. |
Collaborative Arrangements and Licensing Agreements |
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Collaborative Arrangements and Licensing Agreements | 7. Collaborative Arrangements and Licensing Agreements Below, we have included our collaborations with substantive changes during the first three months of 2019 from those included in Note 6 of our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2018. 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 medicines with Biogen’s expertise in developing therapies for neurological disorders. We developed and licensed to Biogen SPINRAZA, our approved medicine to treat people with spinal muscular atrophy, or SMA. In December 2017, we entered into a collaboration with Biogen to identify new antisense medicines for the treatment of SMA. Additionally, we and Biogen are currently developing six other medicines to treat neurodegenerative diseases under these collaborations, including tofersen (formerly IONIS-SOD1Rx) for ALS patients with SOD1 mutations, or SOD1-ALS, which Biogen moved into a Phase 3 study in the first quarter of 2019, IONIS-MAPTRx for Alzheimer’s disease, IONIS-C9Rx for ALS patients with C9ORF72 mutations, and IONIS-BIIB6Rx, IONIS-BIIB7Rx and IONIS-BIIB8Rx to treat undisclosed neurodegenerative diseases. In addition to these medicines, we and Biogen are evaluating numerous additional targets to develop medicines to treat neurological diseases. In April 2018, we entered into a new strategic collaboration for the treatment of neurological diseases with Biogen. From inception through March 2019, we have received over $2.1 billion from our Biogen collaborations, including $1 billion we received from Biogen in the second quarter of 2018 for our 2018 strategic neurology collaboration. During the three months ended March 31, 2019 and 2018, we earned the following revenue from our relationship with Biogen (in millions, except percentage amounts):
During the first quarter of 2019, we did not have any changes to our performance obligations or the timing in which we expect to recognize revenue under our Biogen collaborations. In April 2019, we achieved a $7.5 million milestone payment from Biogen, when we advanced a new target for an unidentified neurological disease under the 2018 strategic neurology collaboration. We will achieve the next payment of up to $10 million if Biogen designates a target under our 2018 strategic neurology collaboration. Our condensed consolidated balance sheet at March 31, 2019 and December 31, 2018 included deferred revenue of $556.4 million and $580.9 million, respectively, related to our relationship with Biogen. Research, Development and Commercialization Partners Roche We have two collaborations with Roche, one to develop treatments for Huntington's disease, or HD, and one to develop IONIS-FB-LRx for the treatment of complement-mediated diseases. In December 2017, upon completion of the Phase 1/2 study of IONIS-HTTRx, Roche exercised its option to license IONIS-HTTRx and is now responsible for the global development, regulatory and commercialization activities for IONIS-HTTRx. 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 plan to evaluate the medicine for 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. From inception through March 2019, we have received over $220 million from our Roche collaborations, including $35 million in milestone payments we earned in the first quarter of 2019 when Roche dosed the first patient in a Phase 3 study for IONIS-HTTRx. We will achieve the next payment of $15 million if Roche advances IONIS-HTTRx. During the three months ended March 31, 2019 and 2018, we earned the following revenue from our relationship with Roche (in millions, except percentage amounts):
Our revenue in the first quarter of 2019, included $35 million of milestone payments we earned when Roche dosed the first patient in the Phase 3 study of IONIS-HTTRx. We recognized these milestone payments in full in the first quarter of 2019 because we do not have any performance obligations related to these milestone payments as Roche is conducting the Phase 3 study of IONIS-HTTRx. During the first quarter of 2019, we did not have any changes to our performance obligations or the timing in which we expect to recognize revenue under our Roche collaborations. Our condensed consolidated balance sheet at March 31, 2019 and December 31, 2018 included deferred revenue of $67.5 million and $72.6 million, respectively, related to our relationship with Roche. Akcea Collaboration The following collaboration agreement relates to Akcea, our majority owned affiliate. Our consolidated results include all the revenue earned and cash received under this collaboration agreement. 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 medicine. If Novartis exercises an option for either of these medicines, Novartis will be responsible for all further global development, regulatory and co-commercialization activities and costs for such medicine. In the first quarter of 2019, Novartis licensed AKCEA-APO(a)-LRx. Novartis is responsible for conducting and funding all future development, regulatory and commercialization activities for AKCEA-APO(a)-LRx, including a global pivotal cardiovascular outcomes study, for which planning and initiation activities are underway. From inception through March 2019, we have received over $330 million from our Novartis collaboration, including $150 million we earned from Novartis in the first quarter of 2019 for the license of AKCEA-APO(a)-LRx. Akcea paid us $75 million as a sublicense fee in 2.8 million shares of Akcea common stock. We identified a new performance obligation when we granted Novartis the license of AKCEA-APO(a)-LRx in the first quarter of 2019 because the license is distinct from our other performance obligations. We recognized the $150 million license fee for AKCEA-APO(a)-LRx as revenue at that time because Novartis 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 Novartis. 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 condensed consolidated balance sheet. During the three months ended March 31, 2019 and 2018, we earned the following revenue from our relationship with Novartis (in millions, except percentage amounts):
During the first quarter of 2019, we did not have any changes to our performance obligations, except as noted above, or the timing in which we expect to recognize revenue under our Novartis collaboration. Our condensed consolidated balance sheet at March 31, 2019 and December 31, 2018 included deferred revenue of $23.3 million and $28.8 million, respectively, related to our relationship with Novartis. |
Segment Information |
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Segment Information | 8. Segment Information We have two reportable segments Ionis Core and Akcea Therapeutics. At March 31, 2019 we owned approximately 76 percent of Akcea. 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 medicines 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 medicines to treat patients with rare and serious diseases. Akcea generates revenue from TEGSEDI product sales and from its collaborations with Novartis and PTC Therapeutics. The following tables show our segment revenue and income (loss) from operations for the three months ended March 31, 2019 and March 31, 2018 (in thousands), respectively.
The following table shows our total assets by segment at March 31, 2019 and December 31, 2018 (in thousands), respectively.
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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 months ended March 31, 2019 and 2018 on the same basis as the audited financial statements for the year ended December 31, 2018. 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, 2018 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. We formed Akcea in December 2014. In July 2017, Akcea completed an initial public offering, or IPO, and therefore, beginning in July 2017, we no longer owned 100 percent of Akcea. In the first quarter of 2019, we received 2.8 million shares of Akcea common stock as payment for the sublicense fee Akcea owed us when Novartis licensed AKCEA-APO(a)-LRx, increasing our ownership to approximately 76 percent at March 31, 2019. We reflected the increase in our ownership in these financial statements. 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 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 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 will also recognize as commercial revenue future sales milestone payments and royalties we earn under our partnerships. Commercial Revenue: TEGSEDI Product Sales, net We added product sales from TEGSEDI to our commercial revenue in the fourth quarter of 2018. In the U.S., TEGSEDI is distributed through an exclusive distribution agreement with a third-party logistics company, or 3PL, that takes title to TEGSEDI. The 3PL is our sole customer in the U.S. The 3PL then distributes TEGSEDI to a specialty pharmacy and a specialty distributor, which we collectively refer to as wholesalers, who then distribute TEGSEDI to health care providers and patients. In Germany, TEGSEDI is distributed through a non-exclusive distribution model with a 3PL that takes title to TEGSEDI. The 3PL is our sole customer in Germany. The 3PL in Germany then distributes TEGSEDI to hospitals and pharmacies. 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. We provide details about our collaboration agreements in Note 7, Collaborative Arrangements and Licensing Agreements, in our Annual Report on Form 10-K for the year ended December 31, 2018. 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 we enter into a collaboration agreement in which we provide our partner with an option to license a medicine 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 medicine 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 medicine 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 and are contingent on certain events. 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 and are usually based on scientific progress. For example, in the first quarter of 2019, we earned $35 million in milestone payments from Roche when it dosed the first patient in the Phase 3 study of IONIS-HTTRx (RG6042) because we do not have any performance obligations related to these milestone payments as Roche is conducting the Phase 3 study of IONIS-HTTRx. At December 31, 2018, we determined it was not probable that we could earn these milestone payments. As such, we did not recognize any revenue associated with the milestone payments in 2018.
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. Commercial Revenue: TEGSEDI Product Sales, net We recognize TEGSEDI product sales in the period when our customer obtains control of TEGSEDI, which occurs at a point in time upon transfer of title to the customer. We classify payments to customers or other parties in the distribution channel for services that are distinct and priced at fair value as selling, general and administrative expenses in our condensed consolidated statements of operations. Otherwise payments to customers or other parties in the distribution channel that do not meet those criteria are classified as a reduction of revenue, as discussed further below. We exclude from revenues, taxes collected from customers relating to product sales and remitted to governmental authorities. Reserves for TEGSEDI Product Sales We record TEGSEDI product sales at our net sales price, or transaction price. We include in our transaction price estimated reserves for discounts, returns, chargebacks, rebates, co-pay assistance and other allowances that we offer within contracts between us and our customers, wholesalers, health care providers and other indirect customers. We estimate our reserves using the amounts we have earned or what we can claim on the associated sales. We classify our reserves as reductions of accounts receivable when the amount is payable to our customer or a current liability when the amount is payable to a party other than our customer in our condensed consolidated balance sheet. In certain cases, our estimates include a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, our reserves reflect our best estimates under the terms of our respective contracts. When calculating our reserves and related product sales, we only recognize amounts to the extent that we consider it probable that we would not have to reverse in a future period a significant amount of the cumulative sales we previously recognized. The actual amounts we receive may ultimately differ from our reserve estimates. If actual amounts in the future vary from our estimates, we will adjust these estimates, which would affect our net TEGSEDI product sales in the respective period. The following are the components of variable consideration related to TEGSEDI product sales: Chargebacks: In the U.S., we estimate obligations resulting from contractual commitments with the government and other entities to sell products to qualified healthcare providers at prices lower than the list prices charged to our U.S. customer. Our U.S. customer charges us for the difference between what it pays for the product and the selling price to the qualified healthcare providers. We record reserves for these chargebacks related to TEGSEDI product sales to our U.S. customer during the reporting period. We also estimate the amount of product remaining in the distribution channel at the end of the reporting period that we expect our customer to sell to healthcare providers in future periods. Government rebates: We are subject to discount obligations under government programs, including Medicaid programs and Medicare in the U.S. and we record reserves for government rebates based on statutory discount rates and estimated utilization. We estimate Medicaid and Medicare rebates based on a range of possible outcomes that are probability-weighted for the estimated payer mix. We record these reserves as an accrued liability on our condensed consolidated balance sheet with a corresponding offset reducing our TEGSEDI product sales in the same period we recognize the related sale. For Medicare, we also estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. On a quarterly basis, we update our estimates and record any adjustments in the period that we identify the adjustments. Trade discounts and allowances: We provide customary invoice discounts on TEGSEDI product sales to our U.S. customer for prompt payment. We record this discount as a reduction of TEGSEDI product sales in the period in which we recognize the related product revenue. In addition, we receive and pay for various distribution services from our U.S. customer and wholesalers in our U.S. distribution channel. For services we receive that are either not distinct from the sale of TEGSEDI or for which we cannot reasonably estimate the fair value, we classify such fees as a reduction of TEGSEDI product sales. Product Returns: Our U.S. customer has return rights and the wholesalers have limited return rights primarily related to the TEGSEDI’s expiration date. We estimate the amount of TEGSEDI product sales that our customer may return. We record our return estimate as an accrued refund liability on our condensed consolidated balance sheet with a corresponding offset reducing our TEGSEDI product sales, in the same period we recognize the related sale. Based on our distribution model for TEGSEDI, contractual inventory limits with our customer and wholesalers and the price of TEGSEDI, we believe we will have minimal returns. Our customer in Germany only takes title to the product once it receives an order from a hospital or pharmacy and therefore does not maintain any inventory of TEGSEDI, as such we do not estimate returns in Germany. Other incentives: In the U.S., we estimate reserves for other incentives including co-payment assistance we provide to patients with commercial insurance who have coverage and reside in states that allow co-payment assistance. We record a reserve for the amount we estimate we will pay for co-payment assistance. We base our reserve on the number of estimated claims and our estimate of the cost per claim related to TEGSEDI product sales that we have recognized as revenue. We record our other incentive reserve estimates as an accrued liability on our condensed consolidated balance sheet with a corresponding offset reducing our TEGSEDI product sales, in the same period we recognize the related sale. 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 collaboration agreement with Roche to develop IONIS-FB-LRx for the treatment of complement-mediated diseases, we received a $75 million upfront payment in the fourth quarter of 2018. We allocated the upfront payment to our single performance obligation, R&D services. We are amortizing the $75 million upfront payment using an input method over the estimated period of time we are providing R&D services. Milestone Payments We are required to include additional consideration in the transaction price when it is probable. 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 medicine is approved by the applicable regulatory agency. 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. We added this payment to the transaction price and allocated it to our R&D services performance obligation. We are recognizing revenue from this milestone payment over our estimated period of performance. Conversely, we recognize in full those milestone payments that we earn based on our partners’ activities when our partner achieves the milestone event and we do not have a performance obligation. For example, in the first quarter of 2019, we recognized $35 million in milestone payments when Roche dosed the first patient in a Phase 3 study for IONIS-HTTRx. We concluded that the milestone payments were not related to our R&D services performance obligation. Therefore, we recognized these milestone payments in full in the first quarter of 2019. 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 first quarter of 2019, we earned a $150 million license fee when Novartis licensed AKCEA-APO(a)-LRx from us. 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 stand-alone 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 7, Collaborative Arrangements and Licensing Agreements, for further discussion of our accounting treatment for our Bayer collaboration. 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. |
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Contracts Receivable | Contracts Receivable Our contracts receivable balance represents the amounts we have billed our partners or customers and that are due to us unconditionally for goods we have delivered or services we have performed. When we bill our partners or customers 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 or customer. |
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Unbilled SPINRAZA Royalties | 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. |
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Deferred Revenue | 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 months ended March 31, 2019 and 2018, we recognized $40.3 million and $34.9 million of revenue from amounts that were in our beginning deferred revenue balance for each respective period. For further discussion, refer to our revenue recognition policy above. |
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Cost of Products Sold | Cost of Products Sold Our cost of products sold includes manufacturing costs, transportation and freight costs and indirect overhead costs associated with the manufacturing and distribution of TEGSEDI. We also may include certain period costs related to manufacturing services and inventory adjustments in cost of products sold. Prior to obtaining regulatory approval in July 2018, we expensed a significant portion of the costs we incurred to produce the TEGSEDI supply we are using in the commercial launch as research and development expense. We previously recognized $0.3 million of costs to produce TEGSEDI related to the TEGSEDI commercial revenue we recognized in the three months ended March 31, 2019. |
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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, third and fourth 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. In the first quarter of 2019, we received 2.8 million shares of Akcea common stock as payment for the sublicense fee Akcea owed us when Novartis licensed AKCEA-APO(a)-LRx, increasing our ownership to approximately 76 percent at March 31, 2019. We reflected this increase in our ownership percentage in these financial statements as an adjustment to noncontrolling interest. 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 condensed 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 March 31, 2019, we held equity investments in two publicly held companies, ProQR Therapeutics N.V., or ProQR, and 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. |
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Inventory Valuation | Inventory valuation We reflect our inventory on our condensed 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 medicines because until we use these raw materials they have alternative future uses. We include in inventory raw material costs for medicines 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 medicine. For example, if one of our medicines failed, we could use the raw materials for that medicine to manufacture our other medicines. We expense these costs as R&D expenses when we begin to manufacture API for a particular medicine if the medicine has not been approved for marketing by a regulatory agency. We obtained the first regulatory approval for TEGSEDI in July 2018. At March 31, 2019 and December 31, 2018, 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 medicines in development and historical write-offs. We did not record any inventory write-offs for the three months ended March 31, 2019 and 2018. Total inventory was $11.1 million and $8.6 million as of March 31, 2019 and December 31, 2018, respectively. |
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Leases | Leases Topic 842 Adoption In February 2016, the FASB issued amended accounting guidance related to lease accounting. This guidance supersedes the lease requirements we previously followed in Accounting Standards Codification, or ASC, Topic 840, Leases, or Topic 840, and created a new lease accounting standard, Topic 842, Leases, or Topic 842. Under Topic 842, an entity will record on its balance sheet all leases with a term longer than one year. Further, an entity will record a liability with a value equal to the present value of payments it will make over the life of the lease (lease liability) and an asset representing the underlying leased asset (right-of-use asset). The new accounting guidance requires entities to determine if its leases are operating or financing leases. Entities will recognize expense for operating leases on a straight-line basis as an operating expense. If an entity determines a lease is a financing lease, it will record both interest and amortization expense and generally the expense will be higher in the earlier periods of the lease. We adopted Topic 842 on January 1, 2019 and adjusted our opening balance sheet on that date for our right-of-use operating lease assets and operating lease liabilities. At adoption, we recorded $13.5 million in right-of-use operating lease assets and $18.5 million in operating lease liabilities, of which we classified $2 million as a current liability. We adopted Topic 842 using the available practical expedients permitted under the transition guidance within the new standard, which among other things, allowed us to carry forward the historical lease classification of those leases we had in place as of January 1, 2019. The adoption did not have an impact on our condensed consolidated statement of operations. Leases We determine if an arrangement contains a lease at inception. We currently only have operating leases. We recognize a right-of-use operating lease asset and associated short- and long-term operating lease liability on our condensed consolidated balance sheet for operating leases greater than one year. Our right-of-use assets represent our right to use an underlying asset for the lease term and our lease liabilities represent our obligation to make lease payments arising from the lease arrangement. We recognize our right-of-use operating lease assets and lease liabilities based on the present value of the future minimum lease payments we will pay over the lease term. We determined the lease term at the commencement date of the lease, and in certain cases our lease term could include renewal options if we concluded we were reasonably certain that we will exercise the renewal option. As our current leases do not provide an interest rate implicit in the lease, we used our or Akcea’s incremental borrowing rate, based on the information available on the date we adopted Topic 842 in determining the present value of future payments. Our right-of-use operating lease asset also includes any lease payments we made and excludes any tenant improvement allowances we received. We recognize rent expense for our minimum lease payments on a straight-line basis over the expected term of our lease. We recognize period expenses, such as common area maintenance expenses, in the period we incur the expense. |
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Research and Development 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. |
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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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Income Taxes | Income Taxes We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in our financial statements or tax returns. In addition, deferred tax assets are recorded for the future benefit of utilizing net operating losses and research and development credit carryforwards. We record a valuation allowance when necessary to reduce our net deferred tax assets to the amount expected to be realized. On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act of 2017, or the Tax Act. The Tax Act created a new requirement on global intangible low-taxed income, or GILTI, earned by foreign subsidiaries for tax years beginning on or after January 1, 2018. The GILTI provisions require foreign subsidiary earnings in excess of an allowable return on the foreign subsidiary’s assets to be included in our U.S. income tax return. Under U.S. GAAP, we are permitted to make an accounting policy election to either treat taxes due on future inclusions in U.S. taxable income related to GILTI as a current-period expense when incurred or to factor such amounts into our measurement of deferred taxes. We have made the election to account for GILTI as a component of current taxes incurred rather than as a component of deferred taxes. |
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Long-Lived Assets | Long-lived assets We evaluate long-lived assets, which include property, plant and equipment, right-of-use operating lease assets 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 months ended March 31, 2019 and 2018 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 income per share for the three months ended March 31, 2019, was calculated as follows (in thousands, except per share amounts):
Our basic net loss per share for the three months ended March 31, 2018, was calculated as follows (in thousands, except per share amounts):
Dilutive net income (loss per share) For the three months ended March 31, 2019, 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 the period. We calculated our diluted net income per share for the three months ended March 31, 2019 as follows (in thousands except per share amounts):
For the three months ended March 31, 2019, the calculation excluded the 1 percent notes because the effect on diluted earnings per share was anti-dilutive. For the three months ended March 31, 2018, 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:
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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 medicines 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 three months ended March 31, 2019 and 2018, we used the following weighted-average assumptions in our Black-Scholes calculations: Ionis Employee Stock Options:
Ionis 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 for the three months ended March 31, 2019 was $58.26 per share. In addition to our stock plans, Akcea has its own stock plan under which it grants options and RSUs and under which it derives its stock-based compensation expense. The following are the weighted-average Black-Scholes assumptions Akcea used under its plan for the three months ended March 31, 2019 and March 31, 2018: Akcea Employee Stock Options:
Akcea ESPP:
The following table summarizes stock-based compensation expense for the three months ended March 31, 2019 and 2018 (in thousands). Our non-cash stock-based compensation expense includes $18.6 million and $6.4 million of stock-based compensation expense for Akcea employees for the three months ended March 31, 2019 and 2018, respectively.
As of March 31, 2019, total unrecognized estimated non-cash stock-based compensation expense related to non-vested stock options and RSUs was $192.2 million and $68.7 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 1.4 years and 2.0 years, respectively. |
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Impact of Recently Issued Accounting Standards | Impact of recently issued accounting standards 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 condensed consolidated financial statements and disclosures. 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 condensed 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 adopted this updated guidance on January 1, 2019 and it did not have a significant impact on our disclosures. In November 2018, the FASB issued clarifying guidance of the interaction between the collaboration accounting guidance and the new revenue recognition guidance we adopted on January 1, 2018 (Topic 606). Below is the clarifying guidance and how we will implement it (in italics):
The updated guidance is effective for public entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. We plan to adopt this guidance on January 1, 2020. We are currently assessing the effects it will have on our condensed consolidated financial statements and disclosures. |
Significant Accounting Policies (Tables) |
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Significant Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Basic Net Income (Loss) per Share | Our basic net income per share for the three months ended March 31, 2019, was calculated as follows (in thousands, except per share amounts):
Our basic net loss per share for the three months ended March 31, 2018, was calculated as follows (in thousands, except per share amounts):
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Basic and Diluted Net Income Per Share | We calculated our diluted net income per share for the three months ended March 31, 2019 as follows (in thousands except per share amounts):
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Significant Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 three months ended March 31, 2019 and 2018, we used the following weighted-average assumptions in our Black-Scholes calculations: Ionis Employee Stock Options:
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Weighted-Average Assumptions for ESPP | Ionis ESPP:
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Stock-Based Compensation Expense | The following table summarizes stock-based compensation expense for the three months ended March 31, 2019 and 2018 (in thousands). Our non-cash stock-based compensation expense includes $18.6 million and $6.4 million of stock-based compensation expense for Akcea employees for the three months ended March 31, 2019 and 2018, respectively.
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Significant Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Weighted-Average Assumptions for Stock Options | In addition to our stock plans, Akcea has its own stock plan under which it grants options and RSUs and under which it derives its stock-based compensation expense. The following are the weighted-average Black-Scholes assumptions Akcea used under its plan for the three months ended March 31, 2019 and March 31, 2018: Akcea Employee Stock Options:
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Weighted-Average Assumptions for ESPP | Akcea ESPP:
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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 March 31, 2019:
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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 March 31, 2019. 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) |
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Fair Value Measurements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assets Measured at Fair Value on a Recurring Basis | The following tables present the major security types we held at March 31, 2019 and December 31, 2018 that we regularly measure and carry at fair value. At March 31, 2019 and December 31, 2018, our ProQR investment was subject to trading restrictions that extend through the fourth quarter of 2019, as a result we included a lack of marketability discount in valuing this investment, which is a Level 3 input. The amount we owned in ProQR did not change from December 31, 2018 to March 31, 2019. 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):
(2) $27.1 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.
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Operating Leases (Tables) |
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Amounts Related to Operating Leases | Amounts related to our operating leases were as follows (dollar amounts in millions):
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||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Future Minimum Payments Under Operating Leases | As of March 31, 2019, the payments for our operating lease liabilities are as follows (in thousands):
|
Collaborative Arrangements and Licensing Agreements (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Biogen [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements and Licensing Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Collaborative Relationship | During the three months ended March 31, 2019 and 2018, we earned the following revenue from our relationship with Biogen (in millions, except percentage amounts):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Roche [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements and Licensing Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Collaborative Relationship | During the three months ended March 31, 2019 and 2018, we earned the following revenue from our relationship with Roche (in millions, except percentage amounts):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Novartis [Member] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Collaborative Arrangements and Licensing Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue from Collaborative Relationship | During the three months ended March 31, 2019 and 2018, we earned the following revenue from our relationship with Novartis (in millions, except percentage amounts):
|
Segment Information (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Information [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Information | The following tables show our segment revenue and income (loss) from operations for the three months ended March 31, 2019 and March 31, 2018 (in thousands), respectively.
The following table shows our total assets by segment at March 31, 2019 and December 31, 2018 (in thousands), respectively.
|
Basis of Presentation (Details) - Akcea [Member] - shares shares in Millions |
3 Months Ended | ||||
---|---|---|---|---|---|
Mar. 31, 2019 |
Dec. 31, 2018 |
Apr. 30, 2018 |
Jul. 31, 2017 |
Jun. 30, 2017 |
|
Basis of Presentation [Abstract] | |||||
Percentage ownership | 76.00% | 75.00% | 68.00% | 68.00% | 100.00% |
Additional shares of Akcea stock received (in shares) | 2.8 |
Significant Accounting Policies, Contracts Receivable (Details) |
3 Months Ended |
---|---|
Mar. 31, 2019 | |
Contracts Receivable [Abstract] | |
Period of time after billing when payment is received | 3 months |
Significant Accounting Policies, Deferred Revenue (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Mar. 31, 2019 |
Mar. 31, 2018 |
|
Deferred Revenue [Abstract] | ||
Revenue recognized from amounts in beginning deferred revenue balance | $ 40.3 | $ 34.9 |
Significant Accounting Policies, Cost of Products Sold (Details) $ in Millions |
Mar. 31, 2019
USD ($)
|
---|---|
Cost of Products Sold [Abstract] | |
Costs incurred to produce TEGSEDI that were previously recognized | $ 0.3 |
Significant Accounting Policies, Noncontrolling Interest in Akcea (Details) - Akcea [Member] - shares shares in Millions |
3 Months Ended | ||||
---|---|---|---|---|---|
Mar. 31, 2019 |
Dec. 31, 2018 |
Apr. 30, 2018 |
Jul. 31, 2017 |
Jun. 30, 2017 |
|
Noncontrolling Interest in Akcea Therapeutics, Inc. [Abstract] | |||||
Percentage ownership | 76.00% | 75.00% | 68.00% | 68.00% | 100.00% |
Additional shares of Akcea stock received (in shares) | 2.8 |
Significant Accounting Policies, Cash, Cash Equivalents and Investments (Details) |
Mar. 31, 2019
Company
|
---|---|
Cash, Cash Equivalents and Investments [Abstract] | |
Number of publicly-held companies in which there is an equity ownership interest of less than 20% | 2 |
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 |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2019 |
Mar. 31, 2018 |
Dec. 31, 2018 |
|
Inventory Valuation [Abstract] | |||
Inventory write-off | $ 0 | $ 0 | |
Inventories | $ 11,057 | $ 8,582 |
Significant Accounting Policies, Leases (Details) - USD ($) $ in Thousands |
Mar. 31, 2019 |
Dec. 31, 2018 |
|||||
---|---|---|---|---|---|---|---|
Operating Leases [Abstract] | |||||||
Right-of-use operating lease assets | [1] | $ 13,100 | |||||
Operating lease liabilties | [2] | 17,960 | |||||
Current portion of operating lease liabilties | $ 2,000 | ||||||
Topic 842 [Member] | |||||||
Operating Leases [Abstract] | |||||||
Right-of-use operating lease assets | $ 13,500 | ||||||
Operating lease liabilties | 18,500 | ||||||
Current portion of operating lease liabilties | $ 2,000 | ||||||
|
Significant Accounting Policies, Segment Information (Details) |
3 Months Ended |
---|---|
Mar. 31, 2019
Segment
| |
Segment Information [Abstract] | |
Number of operating segments | 2 |
Investments, Contract Maturity of Available-for-Sale Securities (Details) |
3 Months Ended |
---|---|
Mar. 31, 2019
Company
| |
Contract Maturity of Available-for-Sale Securities [Abstract] | |
One year or less | 74.00% |
After one year but within two years | 21.00% |
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% | 2 |
Investments, Investments Temporarily Impaired (Details) $ in Thousands |
Mar. 31, 2019
USD ($)
Investment
|
---|---|
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 353 |
Estimated fair value, less than 12 months of temporary impairment | $ 727,648 |
Unrealized losses, less than 12 months of temporary impairment | (430) |
Estimated fair value, more than 12 months of temporary impairment | 170,928 |
Unrealized losses, more than 12 months of temporary impairment | (926) |
Estimated fair value, total temporary impairment | 898,576 |
Unrealized losses, total temporary impairment | $ (1,356) |
Corporate Debt Securities [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 275 |
Estimated fair value, less than 12 months of temporary impairment | $ 530,786 |
Unrealized losses, less than 12 months of temporary impairment | (306) |
Estimated fair value, more than 12 months of temporary impairment | 102,815 |
Unrealized losses, more than 12 months of temporary impairment | (561) |
Estimated fair value, total temporary impairment | 633,601 |
Unrealized losses, total temporary impairment | $ (867) |
Debt Securities issued by U.S. Government Agencies [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 24 |
Estimated fair value, less than 12 months of temporary impairment | $ 91,005 |
Unrealized losses, less than 12 months of temporary impairment | (81) |
Estimated fair value, more than 12 months of temporary impairment | 16,534 |
Unrealized losses, more than 12 months of temporary impairment | (46) |
Estimated fair value, total temporary impairment | 107,539 |
Unrealized losses, total temporary impairment | $ (127) |
Debt Securities issued by the U.S. Treasury [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 15 |
Estimated fair value, less than 12 months of temporary impairment | $ 94,603 |
Unrealized losses, less than 12 months of temporary impairment | (34) |
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 | 94,603 |
Unrealized losses, total temporary impairment | $ (34) |
Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 39 |
Estimated fair value, less than 12 months of temporary impairment | $ 11,254 |
Unrealized losses, less than 12 months of temporary impairment | (9) |
Estimated fair value, more than 12 months of temporary impairment | 51,579 |
Unrealized losses, more than 12 months of temporary impairment | (319) |
Estimated fair value, total temporary impairment | 62,833 |
Unrealized losses, total temporary impairment | $ (328) |
Fair Value Measurements (Details) - USD ($) $ in Thousands |
Mar. 31, 2019 |
Dec. 31, 2018 |
Mar. 31, 2018 |
|||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Investment in ProQR Therapeutics N.V. | $ 968 | $ 1,349 | ||||||||||||||||||
1 Percent 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 Notes [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Fair value of convertible notes | $ 928,400 | |||||||||||||||||||
Recurring Basis [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Cash equivalents | [1] | 146,542 | $ 146,281 | |||||||||||||||||
Investment in ProQR Therapeutics N.V. | [2] | 968 | 1,349 | |||||||||||||||||
Total | 2,067,564 | 2,017,298 | ||||||||||||||||||
Recurring Basis [Member] | Corporate Debt Securities [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | 1,231,154 | [3] | 1,252,960 | [4] | ||||||||||||||||
Recurring Basis [Member] | Corporate Debt Securities [Member] | Cash and Cash Equivalents [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | 27,100 | 50,200 | ||||||||||||||||||
Recurring Basis [Member] | Debt Securities issued by U.S. Government Agencies [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | [5] | 245,308 | 276,612 | |||||||||||||||||
Recurring Basis [Member] | Debt Securities issued by the U.S. Treasury [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | 361,997 | [6] | 260,154 | [7] | ||||||||||||||||
Recurring Basis [Member] | Debt Securities issued by the U.S. Treasury [Member] | Cash and Cash Equivalents [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | 15,000 | 14,200 | ||||||||||||||||||
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 | [5] | 78,663 | 79,942 | |||||||||||||||||
Recurring Basis [Member] | Other Municipal Debt Securities [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | [5] | 2,932 | ||||||||||||||||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Cash equivalents | 146,542 | 146,281 | ||||||||||||||||||
Investment in ProQR Therapeutics N.V. | 0 | 0 | ||||||||||||||||||
Total | 508,539 | 406,435 | ||||||||||||||||||
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 | 361,997 | 260,154 | ||||||||||||||||||
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] | Quoted Prices in Active Markets (Level 1) [Member] | Other Municipal Debt Securities [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | 0 | |||||||||||||||||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Cash equivalents | 0 | 0 | ||||||||||||||||||
Investment in ProQR Therapeutics N.V. | 0 | 0 | ||||||||||||||||||
Total | 1,558,057 | 1,609,514 | ||||||||||||||||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Corporate Debt Securities [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | 1,231,154 | [3] | 1,252,960 | |||||||||||||||||
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 | 245,308 | 276,612 | ||||||||||||||||||
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 | 78,663 | 79,942 | ||||||||||||||||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Other Municipal Debt Securities [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | 2,932 | |||||||||||||||||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Cash equivalents | 0 | 0 | ||||||||||||||||||
Investment in ProQR Therapeutics N.V. | 968 | 1,349 | ||||||||||||||||||
Total | 968 | 1,349 | ||||||||||||||||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | Corporate Debt Securities [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | 0 | 0 | ||||||||||||||||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | Debt Securities issued by U.S. Government Agencies [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | 0 | 0 | ||||||||||||||||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | Debt Securities issued by the U.S. Treasury [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | 0 | 0 | ||||||||||||||||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [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 Unobservable Inputs (Level 3) [Member] | Other Municipal Debt Securities [Member] | ||||||||||||||||||||
Fair Value Measurements [Abstract] | ||||||||||||||||||||
Available-for-sale securities | $ 0 | |||||||||||||||||||
|
Operating Leases (Details) $ in Thousands |
3 Months Ended | ||||||
---|---|---|---|---|---|---|---|
Mar. 31, 2019
USD ($)
Option
|
Mar. 31, 2018
USD ($)
|
||||||
Operating Leases [Abstract] | |||||||
Right-of-use operating lease assets | [1] | $ 13,100 | |||||
Operating lease liabilties | [2] | $ 17,960 | |||||
Weighted average remaining lease term | 9 years | ||||||
Weighted average discount rate | 7.60% | ||||||
Current portion of operating lease liabilties | $ 2,000 | ||||||
Operating lease cash payments | 1,000 | ||||||
Annual Future Minimum Payments Under Operating Leases [Abstract] | |||||||
Remainder of 2019 | 2,341 | ||||||
2020 | 3,008 | ||||||
2021 | 2,725 | ||||||
2022 | 2,539 | ||||||
2023 | 2,505 | ||||||
Thereafter | 11,862 | ||||||
Total minimum payments | 24,980 | ||||||
Imputed interest | (7,020) | ||||||
Total lease liabilities | [2] | 17,960 | |||||
Rent expense | $ 900 | $ 0 | |||||
Office and Laboratory Space Adjacent to Manufacturing Facility [Member] | |||||||
Operating Leases [Abstract] | |||||||
Number of options to extend lease | Option | 2 | ||||||
Term of lease extension | 5 years | ||||||
Office Space Subleased to Akcea [Member] | |||||||
Operating Leases [Abstract] | |||||||
Number of options to extend lease | Option | 1 | ||||||
Term of lease extension | 5 years | ||||||
Akcea [Member] | Office Space for Corporate Headquarters [Member] | |||||||
Operating Leases [Abstract] | |||||||
Term of lease extension | 5 years | ||||||
Term of lease | 123 months | ||||||
Period of free rent under lease | 3 months | ||||||
Tenant improvement allowance | $ 3,800 | ||||||
Initial amount of letter of credit | 2,400 | ||||||
Letter of credit on third anniversary of rent commencement date | 1,800 | ||||||
Letter of credit on fifth anniversary of rent commencement date | $ 1,200 | ||||||
|
Income Taxes (Details) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2019
USD ($)
Component
|
Mar. 31, 2018
USD ($)
|
|
Income Taxes [Abstract] | ||
Effective tax rate | 25.50% | |
Federal statutory rate | 21.00% | |
Income tax expense | $ | $ 31,047 | $ 15 |
Number of income tax expense components | Component | 2 |
Collaborative Arrangements and Licensing Agreements, Biogen (Details) $ in Thousands |
1 Months Ended | 3 Months Ended | |||
---|---|---|---|---|---|
Apr. 30, 2019
USD ($)
|
Mar. 31, 2019
USD ($)
Drug
|
Jun. 30, 2018
USD ($)
|
Mar. 31, 2018
USD ($)
|
Dec. 31, 2018
USD ($)
|
|
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Revenue | $ 297,214 | $ 144,419 | |||
SPINRAZA Royalties [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Revenue | 59,711 | 41,081 | |||
R&D [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Revenue | $ 229,126 | 102,396 | |||
Biogen [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Number of additional drugs in clinical development to treat neurodegenerative diseases | Drug | 6 | ||||
Cumulative payments received | $ 2,100,000 | ||||
Revenue | 84,200 | $ 51,900 | |||
Deferred revenue | $ 556,400 | $ 580,900 | |||
Biogen [Member] | Revenue [Member] | Strategic Partner [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Concentration percentage | 28.00% | 36.00% | |||
Biogen [Member] | SPINRAZA Royalties [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Revenue | $ 59,700 | $ 41,100 | |||
Biogen [Member] | R&D [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Revenue | $ 24,500 | $ 10,800 | |||
2018 Strategic Neurology [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Upfront payment received | $ 1,000,000 | ||||
2018 Strategic Neurology [Member] | Subsequent Event [Member] | |||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||
Milestone payment received | $ 7,500 | ||||
Next prospective milestone | $ 10,000 |
Collaborative Arrangements and Licensing Agreements, Roche (Details) $ in Thousands |
3 Months Ended | 12 Months Ended | |
---|---|---|---|
Mar. 31, 2019
USD ($)
Agreement
|
Mar. 31, 2018
USD ($)
|
Dec. 31, 2018
USD ($)
|
|
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Revenue | $ 297,214 | $ 144,419 | |
R&D [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Revenue | $ 229,126 | $ 102,396 | |
Roche [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Number of collaboration agreements | Agreement | 2 | ||
Deferred revenue | $ 67,500 | $ 72,600 | |
Roche [Member] | Revenue [Member] | Strategic Partner [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Concentration percentage | 14.00% | 1.00% | |
Roche [Member] | R&D [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Revenue | $ 41,200 | $ 2,000 | |
Huntington's Disease [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Number of collaboration agreements | Agreement | 1 | ||
Cumulative payments received | $ 220,000 | ||
Next prospective milestone | 15,000 | ||
Huntington's Disease [Member] | IONIS-HTT [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Revenue | $ 35,000 | $ 0 | |
IONIS-FB-L for Complement-Mediated Diseases [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Number of collaboration agreements | Agreement | 1 |
Collaborative Arrangements and Licensing Agreements, Novartis (Details) - USD ($) $ in Thousands, shares in Millions |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2019 |
Mar. 31, 2018 |
Dec. 31, 2018 |
|
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Revenue | $ 297,214 | $ 144,419 | |
R&D [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Revenue | 229,126 | $ 102,396 | |
Novartis [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Deferred revenue | $ 23,300 | $ 28,800 | |
Novartis [Member] | Revenue [Member] | Strategic Partner [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Concentration percentage | 53.00% | 12.00% | |
Novartis [Member] | Minimum [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Cumulative payments received | $ 330,000 | ||
Novartis [Member] | AKCEA-APO(a)-L [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Revenue | 150,000 | ||
Novartis [Member] | R&D [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Revenue | 157,100 | $ 17,100 | |
Akcea [Member] | |||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||
Sublicense fee paid in stock | $ 75,000 | ||
Additional shares of Akcea stock received (in shares) | 2.8 |
Segment Information (Details) $ in Thousands |
3 Months Ended | |||||
---|---|---|---|---|---|---|
Mar. 31, 2019
USD ($)
Segment
|
Mar. 31, 2018
USD ($)
|
Dec. 31, 2018
USD ($)
|
Apr. 30, 2018 |
Jul. 31, 2017 |
Jun. 30, 2017 |
|
Segment Information [Abstract] | ||||||
Number of reportable segments | Segment | 2 | |||||
Segment Information [Abstract] | ||||||
Revenue | $ 297,214 | $ 144,419 | ||||
Total operating expenses | 175,679 | 147,720 | ||||
Income (loss) from operations | 121,535 | (3,301) | ||||
Total assets as of current period | 2,835,889 | $ 2,667,784 | ||||
Commercial Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 68,088 | 42,023 | ||||
SPINRAZA Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 59,711 | 41,081 | ||||
TEGSEDI Product Sales, Net [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 6,754 | 0 | ||||
Licensing and Other Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 1,623 | 942 | ||||
R&D Revenue Under Collaborative Agreements [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | $ 229,126 | 102,396 | ||||
Akcea [Member] | ||||||
Segment Information [Abstract] | ||||||
Percentage ownership | 76.00% | 75.00% | 68.00% | 68.00% | 100.00% | |
Operating Segments [Member] | Ionis Core [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | $ 221,890 | 132,540 | ||||
Total operating expenses | 114,515 | 105,544 | ||||
Income (loss) from operations | 107,375 | 26,996 | ||||
Total assets as of current period | 3,112,235 | $ 2,975,491 | ||||
Operating Segments [Member] | Ionis Core [Member] | Commercial Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 61,334 | 42,023 | ||||
Operating Segments [Member] | Ionis Core [Member] | SPINRAZA Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 59,711 | 41,081 | ||||
Operating Segments [Member] | Ionis Core [Member] | TEGSEDI Product Sales, Net [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | |||||
Operating Segments [Member] | Ionis Core [Member] | Licensing and Other Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 1,623 | 942 | ||||
Operating Segments [Member] | Ionis Core [Member] | R&D Revenue Under Collaborative Agreements [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 160,556 | 90,517 | ||||
Operating Segments [Member] | Akcea Therapeutics [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 163,816 | 17,108 | ||||
Total operating expenses | 137,610 | 47,435 | ||||
Income (loss) from operations | 26,206 | (30,327) | ||||
Total assets as of current period | 458,717 | 365,261 | ||||
Operating Segments [Member] | Akcea Therapeutics [Member] | Commercial Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 6,754 | 0 | ||||
Operating Segments [Member] | Akcea Therapeutics [Member] | SPINRAZA Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | 0 | ||||
Operating Segments [Member] | Akcea Therapeutics [Member] | TEGSEDI Product Sales, Net [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 6,754 | |||||
Operating Segments [Member] | Akcea Therapeutics [Member] | Licensing and Other Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | 0 | ||||
Operating Segments [Member] | Akcea Therapeutics [Member] | R&D Revenue Under Collaborative Agreements [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 157,062 | 17,108 | ||||
Elimination of Intercompany Activity [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | (88,492) | (5,229) | ||||
Total operating expenses | (76,446) | (5,259) | ||||
Income (loss) from operations | (12,046) | 30 | ||||
Total assets as of current period | (735,063) | $ (672,968) | ||||
Elimination of Intercompany Activity [Member] | Commercial Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | 0 | ||||
Elimination of Intercompany Activity [Member] | SPINRAZA Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | 0 | ||||
Elimination of Intercompany Activity [Member] | TEGSEDI Product Sales, Net [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | |||||
Elimination of Intercompany Activity [Member] | Licensing and Other Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | 0 | ||||
Elimination of Intercompany Activity [Member] | R&D Revenue Under Collaborative Agreements [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | $ (88,492) | $ (5,229) |
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