Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2020 | Jul. 29, 2020 | |
Cover [Abstract] | ||
Entity Registrant Name | Ionis Pharmaceuticals, Inc. | |
Entity Central Index Key | 0000874015 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Shell Company | false | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 139,697,030 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 000-19125 | |
Entity Tax Identification Number | 33-0336973 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 2855 Gazelle Court | |
Entity Address, City or Town | Carlsbad | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92010 | |
City Area Code | 760 | |
Local Phone Number | 931-9200 | |
Title of 12(b) Security | Common Stock, $.001 Par Value | |
Trading Symbol | IONS | |
Security Exchange Name | NASDAQ |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 530,181 | $ 683,287 |
Short-term investments | 1,818,435 | 1,816,257 |
Contracts receivable | 27,834 | 63,034 |
Inventories | 23,722 | 18,180 |
Other current assets | 131,015 | 139,839 |
Total current assets | 2,531,187 | 2,720,597 |
Property, plant and equipment, net | 172,618 | 153,651 |
Patents, net | 27,700 | 25,674 |
Long-term deferred tax assets | 305,980 | 305,557 |
Deposits and other assets | 41,465 | 27,633 |
Total assets | 3,078,950 | 3,233,112 |
Current liabilities: | ||
Accounts payable | 7,407 | 16,067 |
Accrued compensation | 22,822 | 37,357 |
Accrued liabilities | 67,802 | 66,769 |
Income taxes payable | 27,943 | 32,514 |
Current portion of long-term obligations and other current liabilities | 4,966 | 2,026 |
Current portion of deferred contract revenue | 100,401 | 118,272 |
Total current liabilities | 231,341 | 273,005 |
Long-term deferred contract revenue | 448,576 | 490,060 |
Long-term obligations, less current portion | 15,057 | 15,543 |
Long-term mortgage debt | 59,948 | 59,913 |
Total liabilities | 1,484,155 | 1,548,565 |
Stockholders' equity: | ||
Common stock, $0.001 par value; 300,000,000 shares authorized, 139,489,405 and 140,339,615 shares issued and outstanding at June 30, 2020 (unaudited) and December 31, 2019, respectively | 139 | 140 |
Additional paid-in capital | 2,271,630 | 2,203,778 |
Accumulated other comprehensive loss | (16,440) | (25,290) |
Accumulated deficit | (878,154) | (707,534) |
Total Ionis stockholders' equity | 1,377,175 | 1,471,094 |
Noncontrolling interest in Akcea Therapeutics, Inc. | 217,620 | 213,453 |
Total stockholders' equity | 1,594,795 | 1,684,547 |
Total liabilities and stockholders' equity | 3,078,950 | 3,233,112 |
0.125 Percent Convertible Senior Notes [Member] | ||
Current liabilities: | ||
Convertible senior notes | 445,150 | 434,711 |
1 Percent Convertible Senior Notes [Member] | ||
Current liabilities: | ||
Convertible senior notes | $ 284,083 | $ 275,333 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
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) | 139,489,405 | 140,339,615 |
Common stock, shares outstanding (in shares) | 139,489,405 | 140,339,615 |
0.125 Percent Convertible Senior Notes [Member] | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Interest rate on convertible senior notes | 0.125% | 0.125% |
1 Percent Convertible Senior Notes [Member] | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Interest rate on convertible senior notes | 1.00% | 1.00% |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenue: | ||||
Revenue | $ 145,537 | $ 163,813 | $ 278,905 | $ 461,026 |
Expenses: | ||||
Cost of products sold | 3,012 | 1,364 | 5,561 | 2,406 |
Research, development and patent | 122,264 | 106,165 | 239,214 | 212,582 |
Selling, general and administrative | 72,015 | 75,111 | 147,009 | 143,332 |
Total operating expenses | 197,291 | 182,640 | 391,784 | 358,320 |
Income (loss) from operations | (51,754) | (18,827) | (112,879) | 102,706 |
Other income (expense): | ||||
Investment income | 9,243 | 13,735 | 19,459 | 25,880 |
Interest expense | (11,173) | (11,802) | (22,163) | (23,402) |
Gain on investments | 9,625 | 0 | 9,887 | 0 |
Other income (expenses) | (149) | (45) | (249) | (192) |
Income (loss) before income tax (expense) benefit | (44,208) | (16,939) | (105,945) | 104,992 |
Income tax (expense) benefit | 439 | 6,927 | 3,696 | (24,119) |
Net income (loss) | (43,769) | (10,012) | (102,249) | 80,873 |
Net loss attributable to noncontrolling interest in Akcea Therapeutics, Inc. | 11,924 | 9,136 | 22,178 | 2,694 |
Net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders | $ (31,845) | $ (876) | $ (80,071) | $ 83,567 |
Basic net income (loss) per share (in dollars per share) | $ (0.23) | $ (0.01) | $ (0.58) | $ 0.62 |
Shares used in computing basic net income (loss) per share (in shares) | 139,352 | 140,247 | 139,391 | 139,419 |
Diluted net income (loss) per share (in dollars per share) | $ (0.23) | $ (0.01) | $ (0.58) | $ 0.61 |
Shares used in computing diluted net income (loss) per share (in shares) | 139,352 | 140,247 | 139,391 | 142,499 |
Commercial Revenue [Member] | ||||
Revenue: | ||||
Revenue | $ 89,734 | $ 88,299 | $ 173,696 | $ 156,386 |
SPINRAZA Royalties [Member] | ||||
Revenue: | ||||
Revenue | 71,746 | 70,502 | 137,754 | 130,212 |
Product Sales, Net [Member] | ||||
Revenue: | ||||
Revenue | 16,364 | 9,865 | 31,523 | 16,619 |
Licensing and Other Royalty Revenue [Member] | ||||
Revenue: | ||||
Revenue | 1,624 | 7,932 | 4,419 | 9,555 |
Research and Development Revenue Under Collaborative Agreements [Member] | ||||
Revenue: | ||||
Revenue | $ 55,803 | $ 75,514 | $ 105,209 | $ 304,640 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Unaudited) [Abstract] | ||||
Net income (loss) | $ (43,769) | $ (10,012) | $ (102,249) | $ 80,873 |
Unrealized gains (losses) on debt securities, net of tax | 11,204 | 3,452 | 9,251 | 7,775 |
Currency translation adjustment | 74 | (96) | 82 | (11) |
Comprehensive income (loss) | (32,491) | (6,656) | (92,916) | 88,637 |
Comprehensive loss attributable to noncontrolling interests | (11,441) | (9,136) | (21,695) | (2,696) |
Comprehensive income (loss) attributable to Ionis Pharmaceuticals, Inc. stockholders | $ (21,050) | $ 2,480 | $ (71,221) | $ 91,333 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($) shares in Thousands, $ in Thousands | Common Stock [Member] | Additional Paid In Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] | Total Ionis Stockholders' Equity [Member] | Noncontrolling Interest in Akcea Therapeutics, Inc. [Member] | Total |
Balance at Dec. 31, 2018 | $ 138 | $ 2,047,250 | $ (32,016) | $ (967,293) | $ 1,048,079 | $ 139,081 | $ 1,187,160 |
Balance (in shares) at Dec. 31, 2018 | 137,929 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net income (loss) | $ 0 | 0 | 0 | 83,567 | 83,567 | 0 | 83,567 |
Change in unrealized gains, net of tax | 0 | 0 | 7,775 | 0 | 7,775 | 0 | 7,775 |
Foreign currency translation | 0 | 0 | (11) | 0 | (11) | 0 | (11) |
Issuance of common stock in connection with employee stock plans | $ 2 | 102,002 | 0 | 0 | 102,004 | 0 | 102,004 |
Issuance of common stock in connection with employee stock plans (in shares) | 2,600 | ||||||
Stock-based compensation expense | $ 0 | 87,437 | 0 | 0 | 87,437 | 0 | 87,437 |
Payments of tax withholdings related to vesting of employee stock awards and exercise of employee stock options | $ 0 | (8,034) | 0 | 0 | (8,034) | 0 | (8,034) |
Payments of tax withholdings related to vesting of employee stock awards and exercise of employee stock options (in shares) | (136) | ||||||
Noncontrolling interest in Akcea Therapeutics, Inc. | $ 0 | (51,433) | 0 | 0 | (51,433) | 48,737 | (2,696) |
Balance at Jun. 30, 2019 | $ 140 | 2,177,222 | (24,252) | (883,726) | 1,269,384 | 187,818 | 1,457,202 |
Balance (in shares) at Jun. 30, 2019 | 140,393 | ||||||
Balance at Mar. 31, 2019 | $ 140 | 2,117,969 | (27,608) | (882,850) | 1,207,651 | 179,769 | 1,387,420 |
Balance (in shares) at Mar. 31, 2019 | 139,624 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net income (loss) | $ 0 | 0 | 0 | (876) | (876) | 0 | (876) |
Change in unrealized gains, net of tax | 0 | 0 | 3,452 | 0 | 3,452 | 0 | 3,452 |
Foreign currency translation | 0 | 0 | (96) | 0 | (96) | 0 | (96) |
Issuance of common stock in connection with employee stock plans | $ 0 | 34,943 | 0 | 0 | 34,943 | 0 | 34,943 |
Issuance of common stock in connection with employee stock plans (in shares) | 774 | ||||||
Stock-based compensation expense | $ 0 | 41,933 | 0 | 0 | 41,933 | 0 | 41,933 |
Payments of tax withholdings related to vesting of employee stock awards and exercise of employee stock options | $ 0 | (438) | 0 | 0 | (438) | 0 | (438) |
Payments of tax withholdings related to vesting of employee stock awards and exercise of employee stock options (in shares) | (5) | ||||||
Noncontrolling interest in Akcea Therapeutics, Inc. | $ 0 | (17,185) | 0 | 0 | (17,185) | 8,049 | (9,136) |
Balance at Jun. 30, 2019 | $ 140 | 2,177,222 | (24,252) | (883,726) | 1,269,384 | 187,818 | 1,457,202 |
Balance (in shares) at Jun. 30, 2019 | 140,393 | ||||||
Balance at Dec. 31, 2019 | $ 140 | 2,203,778 | (25,290) | (707,534) | 1,471,094 | 213,453 | 1,684,547 |
Balance (in shares) at Dec. 31, 2019 | 140,340 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net income (loss) | $ 0 | 0 | 0 | (80,071) | (80,071) | 0 | (80,071) |
Change in unrealized gains, net of tax | 0 | 0 | 9,251 | 0 | 9,251 | 0 | 9,251 |
Foreign currency translation | 0 | 0 | 82 | 0 | 82 | 0 | 82 |
Issuance of common stock in connection with employee stock plans | $ 0 | 16,451 | 0 | 0 | 16,451 | 0 | 16,451 |
Issuance of common stock in connection with employee stock plans (in shares) | 821 | ||||||
Repurchases and retirements of common stock | $ (1) | 0 | 0 | (90,549) | (90,550) | 0 | (90,550) |
Repurchases and retirements of common stock (in shares) | (1,478) | ||||||
Stock-based compensation expense | $ 0 | 89,233 | 0 | 0 | 89,233 | 0 | 89,233 |
Payments of tax withholdings related to vesting of employee stock awards and exercise of employee stock options | $ 0 | (11,970) | 0 | 0 | (11,970) | 0 | (11,970) |
Payments of tax withholdings related to vesting of employee stock awards and exercise of employee stock options (in shares) | (194) | ||||||
Noncontrolling interest in Akcea Therapeutics, Inc. | $ 0 | (25,862) | (483) | 0 | (26,345) | 4,167 | (22,178) |
Balance at Jun. 30, 2020 | $ 139 | 2,271,630 | (16,440) | (878,154) | 1,377,175 | 217,620 | 1,594,795 |
Balance (in shares) at Jun. 30, 2020 | 139,489 | ||||||
Balance at Mar. 31, 2020 | $ 139 | 2,233,644 | (27,235) | (846,309) | 1,360,239 | 210,172 | 1,570,411 |
Balance (in shares) at Mar. 31, 2020 | 139,282 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net income (loss) | $ 0 | 0 | 0 | (31,845) | (31,845) | 0 | (31,845) |
Change in unrealized gains, net of tax | 0 | 0 | 11,204 | 0 | 11,204 | 0 | 11,204 |
Foreign currency translation | 0 | 0 | 74 | 0 | 74 | 0 | 74 |
Issuance of common stock in connection with employee stock plans | $ 0 | 8,800 | 0 | 0 | 8,800 | 0 | 8,800 |
Issuance of common stock in connection with employee stock plans (in shares) | 214 | ||||||
Stock-based compensation expense | $ 0 | 48,442 | 0 | 0 | 48,442 | 0 | 48,442 |
Payments of tax withholdings related to vesting of employee stock awards and exercise of employee stock options | $ 0 | (367) | 0 | 0 | (367) | 0 | (367) |
Payments of tax withholdings related to vesting of employee stock awards and exercise of employee stock options (in shares) | (7) | ||||||
Noncontrolling interest in Akcea Therapeutics, Inc. | $ 0 | (18,889) | (483) | 0 | (19,372) | 7,448 | (11,924) |
Balance at Jun. 30, 2020 | $ 139 | $ 2,271,630 | $ (16,440) | $ (878,154) | $ 1,377,175 | $ 217,620 | $ 1,594,795 |
Balance (in shares) at Jun. 30, 2020 | 139,489 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Operating activities: | ||||||
Net income (loss) | $ (43,769) | $ (10,012) | $ (102,249) | $ 80,873 | ||
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | ||||||
Depreciation | 6,360 | 6,253 | ||||
Amortization of right-of-use operating lease assets | 784 | 1,035 | ||||
Amortization of patents | 999 | 948 | ||||
Amortization of premium (discount) on investments, net | 3,842 | (5,163) | ||||
Amortization of debt issuance costs | 1,236 | 957 | ||||
Amortization of convertible senior notes discount | 17,807 | 17,661 | ||||
Stock-based compensation expense | 89,233 | 87,437 | ||||
Gain on investments | (9,625) | 0 | (9,887) | 0 | ||
Non-cash losses related to patents, licensing and property, plant and equipment and investments | 211 | 203 | ||||
Provision for deferred income taxes | (2,513) | 14,436 | ||||
Changes in operating assets and liabilities: | ||||||
Contracts receivable | 35,200 | (16,255) | ||||
Inventories | (3,018) | (5,736) | ||||
Other current and long-term assets | 1,064 | (6,372) | ||||
Accounts payable | (14,939) | (16,104) | ||||
Accrued compensation | (14,535) | (9,219) | ||||
Other current liabilities | (1,968) | 3,283 | ||||
Deferred contract revenue | (59,355) | (73,643) | ||||
Net cash provided by (used in) operating activities | (51,728) | 80,594 | ||||
Investing activities: | ||||||
Purchases of short-term investments | (976,284) | (1,049,274) | ||||
Proceeds from sale of short-term investments | 982,173 | 877,966 | ||||
Purchases of property, plant and equipment | (18,178) | (7,243) | ||||
Acquisition of licenses and other assets, net | (3,023) | (2,310) | ||||
Net cash used in investing activities | (15,312) | (180,861) | ||||
Financing activities: | ||||||
Proceeds from issuance of equity, net | 16,453 | 102,004 | ||||
Payments of tax withholdings related to vesting of employee stock awards and exercise of employee stock options | (11,971) | (8,034) | ||||
Repurchases and retirements of common stock | $ (90,600) | (90,548) | 0 | $ (34,400) | ||
Net cash provided by (used in) financing activities | (86,066) | 93,970 | ||||
Net increase in cash and cash equivalents | (153,106) | (6,297) | ||||
Cash and cash equivalents at beginning of period | $ 683,287 | 683,287 | 278,820 | 278,820 | ||
Cash and cash equivalents at end of period | $ 530,181 | $ 272,523 | 530,181 | 272,523 | $ 683,287 | |
Supplemental disclosures of cash flow information: | ||||||
Interest paid | 3,093 | 4,776 | ||||
Income taxes paid | 49 | 0 | ||||
Supplemental disclosures of non-cash investing and financing activities: | ||||||
Right-of-use assets obtained in exchange for lease liabilities | 0 | 13,920 | ||||
Amounts accrued for capital and patent expenditures | $ 6,461 | $ 3,073 |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2020 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | 1. Basis of Presentation We prepared the unaudited interim condensed consolidated financial statements for the three and six months ended June 30, 2020 and 2019 on the same basis as the audited financial statements for the year ended December 31, 2019. 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. Our operating results for the interim periods may not be indicative of what our operating results will be 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, 2019 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. initial public offering, or IPO. Since Akcea’s IPO, our ownership has ranged from to . Rx 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
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
Significant Accounting Policies [Abstract] | |
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 condensed consolidated balance sheet. Commercial Revenue: SPINRAZA royalties and Licensing and other royalty revenue We earn commercial revenue primarily in the form of royalty payments on net sales of SPINRAZA. We will also recognize as commercial revenue sales milestone payments and royalties we earn in the future under our partnerships. Commercial Revenue: Product sales, net We added product sales from TEGSEDI to our commercial revenue in the fourth quarter of 2018 and we added product sales from WAYLIVRA to our commercial revenue in the third quarter of 2019. 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. In Note 6, Collaborative Arrangements and Licensing Agreements 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: 1. Identify the contract First we determine if we have a contract with our partner, including confirming that we have met each of the following criteria: ● 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 of the consideration is probable. 2. Identify the performance obligations We next identify our performance obligations, which represent the distinct goods and services we are required to provide under the contract. 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 because 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 material performance obligations related to the license after delivery, then we consider the license to be a separate performance obligation. 3. Determine the transaction price 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 future 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 2020, we earned a $10 million milestone payment from AstraZeneca when AstraZeneca advanced ION532 targeting APOL1 for the treatment of kidney disease under our cardiovascular, renal and metabolic diseases collaboration 4. Allocate the transaction price 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 do not reallocate the transaction price after the start of an agreement to reflect subsequent changes in stand-alone selling prices. 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: ● Estimated future product sales; ● Estimated royalties we may receive from future product sales; ● Estimated contractual milestone payments we may receive; ● Expenses we expect to incur; ● Income taxes; and ● A discount rate. 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: ● 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. 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. 5. Recognize revenue 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. For example, 2013 Strategic Neurology collaboration with Biogen significant portion of the research and development services. In this example, we expected to complete the remainder of our services in 2020. As a result of our change in estimate, in the third quarter of 2019, we recorded a cumulative catch up adjustment of $ million to decrease revenue. Refer to Note 6, Collaborative Arrangements and Licensing Agreements , for further discussion of the cumulative catch up adjustment we made in 2019. 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, including royalties from SPINRAZA sales, in the period in which the counterparty sells the related product and recognizes the related revenue, which in certain cases may require us to estimate our royalty revenue. Commercial Revenue: Product sales, net We recognize product sales in the period Reserves for Product sales We record 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 a reduction of accounts receivable when we are not required to make a payment or as a current liability when we are required to make a payment. 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 product sales in the respective period. The following are the components of variable consideration related to product sales: Chargebacks: Government rebates : We are subject t Managed care rebates: Trade discounts: Distribution services Product returns: Other incentives: 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-L Rx for the treatment of complement-mediated diseases 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. 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 in which 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 first quarter of 2020, we achieved a $7.5 million milestone payment from Biogen when we advanced IONIS-MAPT Rx Rx 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 2020, we recognized a $10 million milestone payment when AstraZeneca advanced ION532 targeting APOL1 for the treatment of kidney disease under our cardiovascular, renal and metabolic diseases collaboration agreement We concluded that the milestone payment was not related to our R&D services performance obligation. Therefore, we recognized the milestone payment in full in the first quarter of 2020. License fees We generally recognize as revenue the total amount we determine to be the relative 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. Sublicense fees We recognize sublicense fee revenue in the period in which a party, who has already licensed our technology, further licenses the technology to another party because we do not have any performance obligations related to the sublicense. 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: 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. 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-FXI Rx for the prevention of thrombosis. As part of the agreement, Bayer paid us a $ million upfront payment. At the onset of the agreement, we were responsible for completing a Phase 2 study of IONIS-FXI Rx 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-FXI Rx and to initiate development of IONIS-FXI-L Rx , which Bayer licensed. As part of the 2017 amendment, Bayer paid us $ million. We are also eligible to receive milestone payments and tiered royalties on gross margins of IONIS-FXI Rx and IONIS-FXI-L Rx . Under the 2017 amendment, we concluded we had a new agreement with performance obligations. These performance obligations were to deliver the license of IONIS-FXI-L Rx , to provide R&D services and to deliver API. We allocated the $ million transaction price to these performance obligations. Refer to Note 6, Collaborative Arrangements and Licensing Agreements , for further discussion of the 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: ● 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. 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. 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. 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 our products. We also may include certain period costs related to manufacturing services and inventory adjustments in cost of products sold. Prior to obtaining regulatory approval of TEGSEDI in July 2018 and WAYLIVRA in May 2019, we expensed as research and development expenses a significant portion of the costs we incurred to produce the initial commercial launch supply for each medicine. Noncontrolling Interest in Akcea Therapeutics, Inc. Prior to Akcea’s IPO in July 2017, we owned 100 percent of Akcea. Since Akcea’s IPO, our ownership has ranged from to . ● 2.8 million shares in the first quarter of 2019 as payment for the sublicense fee Akcea owed us for Novartis’s license of AKCEA-APO(a)-L Rx ● 6.9 million shares in the fourth quarter of 2019 as payment for the sublicense fee Akcea owed us for Pfizer’s license of vupanorsen. The shares third parties own represent an interest in Akcea’s equity that we do control. 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 June 30, 2020, 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 five privately-held companies, Atlantic Pharmaceuticals Limited, Dynacure SAS, Empirico, Inc., Seventh Sense Biosystems and Suzhou Ribo Life Science Co, Ltd. We are required to measure and record our equity investments at fair value and to recognize the changes in fair value in our condensed consolidated statement of operations. We account for our equity investments in privately held companies at their cost minus impairments, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer. For example, during the second quarter of 2020, we revalued our investments in two privately-held companies, Dynacure and Ribo because the companies sold additional equity securities that were similar to those we own. These observable price changes resulted in us recognizing a $6.3 million gain on our investment in Dynacure and a $3 million gain on our investment in Ribo in our condensed consolidated statement of operations during the three months ended June 30, 2020. 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, which we refer to as clinical raw materials. 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 and for WAYLIVRA in May 2019. At June 30, 2020, our physical inventory for TEGSEDI and WAYLIVRA included API that we produced prior to when we obtained regulatory approval. As such, this API 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 material inventory write-offs for the . Total inventory was $ million and $ million as of , respectively, and June 30, 2020 December 31, 2019 Raw materials: Raw materials- clinical $ 9,967 $ 9,363 Raw materials- commercial 9,543 6,520 Total raw materials 19,510 15,883 Work in process 3,471 2,039 Finished goods 741 258 Total inventory $ 23,722 $ 18,180 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. As our current leases do not provide an interest rate implicit in the lease, we used our incremental borrowing rate, based on the information available on the date we adopted Topic 842 (January 2019) or as of the lease inception date in determining the present value of future payments. 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 U.S. Patent and Trademark Office, or foreign equivalent, issues the patent. . 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. Long-lived Assets We evaluate long-lived assets, which include property, plant and equipment and patent costs, 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 Basic and Diluted Net Income (Loss) Per Share Basic net income (loss) per share We compute basic net income (loss) per share by dividing the total net income (loss) attributable to our common stockholders by our weighted-average number of common shares outstanding during the period. The calculation of total net income (loss) attributable to our common stockholders for the three and six months ended June 30, 2020 and 2019 considered our net income (loss) for Ionis on a stand-alone basis plus our share of Akcea’s net income (loss) for the period. To calculate the portion of Akcea’s net loss attributable to our ownership, we multiplied Akcea’s net income (loss) per share by the weighted average shares we owned in Akcea during the period. As a result of this calculation, our total net income (loss) available to Ionis common stockholders for the calculation of net income (loss) per share is different than net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders in the condensed consolidated statements of operations. Our basic net loss per share for the three months ended June 30, 2020, was calculated as follows (in thousands, except per share amounts): Three months ended June 30, 2020 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Basic Net Loss Per Share Calculation Ionis’ portion of Akcea’s net loss 77,095 $ (0.49 ) $ (37,665 ) Akcea’s net loss attributable to our ownership $ (37,665 ) Ionis’ stand-alone net income 5,807 Net loss available to Ionis common stockholders $ (31,858 ) Weighted average shares outstanding 139,352 Basic net loss per share $ (0.23 ) Our basic net loss per share for the six months ended Six months ended June 30, 2020 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Basic Net Loss Per Share Calculation Ionis’ portion of Akcea’s net loss 77,095 $ (0.91 ) $ (70,348 ) Akcea’s net loss attributable to our ownership $ (70,348 ) Ionis’ stand-alone net loss (9,822 ) Net loss available to Ionis common stockholders $ (80,170 ) Weighted average shares outstanding 139,391 Basic net loss per share $ (0.58 ) Our basic net loss per share for the three months ended June 30, 2019, was calculated as follows (in thousands, except per share amounts): Three months ended June 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Income Per Share Basic Net Loss Per Share Calculation Ionis’ portion of Akcea’s net loss 70,221 $ (0.40 ) $ (28,244 ) Akcea’s net loss attributable to our ownership $ (28,244 ) Ionis’ stand-alone net income 27,311 Net loss available to Ionis common stockholders $ (933 ) Weighted average shares outstanding 140,247 Basic net loss per share $ (0.01 ) Our basic net income per share for the six months ended Six months ended June 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Basic Net Income Per Share Calculation Ionis’ portion of Akcea’s net loss 69,406 $ (0.06 ) $ (4,380 ) Akcea’s net loss attributable to our ownership $ (4,380 ) Ionis’ stand-alone net income 91,008 Net income available to Ionis common stockholders $ 86,628 Weighted average shares outstanding 139,419 Basic net income per share $ 0.62 Diluted net income (loss) per share For the three and six months ended June 30, 2020 and the three months ended June 30, 2019, 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: ● 0.125 percent convertible senior notes (for the three and six months ended June 30, 2020); ● 1 percent convertible senior notes; ● Dilutive stock options; ● Unvested restricted stock units; and ● Employee Stock Purchase Plan, or ESPP. For the six months ended June 30, 2019, we had net income ava |
Investments
Investments | 6 Months Ended |
Jun. 30, 2020 | |
Investments [Abstract] | |
Investments | 3. Investments The following table summarizes the contract maturity of the available-for-sale securities we held as of June 30, 2020: One year or less 69 % After one year but within two years 23 % After two years but within three years 8 % Total 100 % As illustrated above, at June 30, 2020, 92 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. We invest in available-for-sale securities At June 30, 2020, we had an ownership interest of less than 20 percent in five private companies and two public companies with which we conduct business. The privately-held companies are Atlantic Pharmaceuticals Limited, Dynacure SAS, Empirico, Inc., Seventh Sense Biosystems and Suzhou Ribo Life Science Co, Ltd. The publicly-traded companies are ATL and ProQR. The following is a summary of our investments (in thousands): Gross Unrealized Estimated June 30, 2020 Cost Gains Losses Fair Value Available-for-sale securities: Corporate debt securities (2) $ 652,555 $ 4,275 $ (17 ) $ 656,813 Debt securities issued by U.S. government agencies 139,810 673 (9 ) 140,474 Debt securities issued by the U.S. Treasury (2) 325,925 815 (7 ) 326,733 Debt securities issued by states of the U.S. and political subdivisions of the states 68,651 214 (3 ) 68,862 Other municipal debt securities 902 7 — 909 Total securities with a maturity of one year or less 1,187,843 5,984 (36 ) 1,193,791 Corporate debt securities 485,487 8,780 (121 ) 494,146 Debt securities issued by U.S. government agencies 118,538 521 (28 ) 119,031 Debt securities issued by the U.S. Treasury 58,334 588 (4 ) 58,918 Debt securities issued by states of the U.S. and political subdivisions of the states 50,514 371 (3 ) 50,882 Total securities with a maturity of more than one year 712,873 10,260 (156 ) 722,977 Total available-for-sale securities $ 1,900,716 $ 16,244 $ (192 ) $ 1,916,768 Equity securities: Total equity securities included in other current assets (3) $ 4,712 $ — $ (2,322 ) $ 2,390 Total equity securities included in deposits and other assets (4) 15,019 9,318 — 24,337 Total equity securities 19,731 9,318 (2,322 ) 26,727 Total available-for-sale and equity securities $ 1,920,447 $ 25,562 $ (2,514 ) $ 1,943,495 Gross Unrealized Estimated December 31, 2019 Cost Gains Losses Fair Value Available-for-sale securities: Corporate debt securities (2) $ 669,665 $ 1,451 $ (43 ) $ 671,073 Debt securities issued by U.S. government agencies 188,216 303 (43 ) 188,476 Debt securities issued by the U.S. Treasury (2) 327,670 232 (27 ) 327,875 Debt securities issued by states of the U.S. and political subdivisions of the states (2) 21,065 26 (5 ) 21,086 Total securities with a maturity of one year or less 1,206,616 2,012 (118 ) 1,208,510 Corporate debt securities 428,627 2,911 (43 ) 431,495 Debt securities issued by U.S. government agencies 140,988 57 (117 ) 140,928 Debt securities issued by the U.S. Treasury 35,822 9 (12 ) 35,819 Debt securities issued by states of the U.S. and political subdivisions of the states 19,309 18 (6 ) 19,321 Total securities with a maturity of more than one year 624,746 2,995 (178 ) 627,563 Total available-for-sale securities $ 1,831,362 $ 5,007 $ (296 ) $ 1,836,073 Equity securities: Total equity securities included in other current assets (3) 4,712 — (870 ) 3,842 Total equity securities included in deposits and other assets (4) 10,000 — — 10,000 Total equity securities 14,712 — (870 ) 13,842 Total available-for-sale and equity securities $ 1,846,074 $ 5,007 $ (1,166 ) $ 1,849,915 (1) We hold our available-for-sale securities at amortized cost. (2) Includes investments classified as cash equivalents on our condensed consolidated balance sheet. (3) Our equity securities included in other current assets consisted of our investments in publicly-traded companies. We recognize publicly-traded equity securities at fair value. (4) Our equity securities included in deposits and other assets consisted of our investments in privately-held companies. We recognize our private company equity securities at on our condensed consolidated balance sheet. The following is a summary of our investments we consider to be temporarily impaired at (in thousands). 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. Less than 12 Months of Temporary Impairment More than 12 Months of Temporary Impairment Total Temporary Impairment Number of Investments Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Corporate debt securities 37 $ 87,460 $ (138 ) $ — $ — $ 87,460 $ (138 ) Debt securities issued by U.S. government agencies 10 44,389 (33 ) 26,997 (4 ) 71,386 (37 ) Debt securities issued by the U.S. Treasury 9 110,067 (11 ) — — 110,067 (11 ) Debt securities issued by states of the U.S. and political subdivisions of the states 22 7,763 (6 ) — — 7,763 (6 ) Total temporarily impaired securities 78 $ 249,679 $ (188 ) $ 26,997 $ (4 ) $ 276,676 $ (192 ) |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements We use a three-tier fair value hierarchy to prioritize the inputs used in our fair value measurements. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets for identical assets, which includes our money market funds and treasury securities classified as available-for-sale securities and our investment in equity securities in publicly-held biotechnology companies; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable, which includes our fixed income securities and commercial paper classified as available-for-sale securities; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring us to develop our own assumptions. We classify most 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 and that we regularly measure and carry at fair value. At and , subject to trading restrictions that extend to the fourth quarter of 2020; as a result, we The amount we owned in ProQR did not change from to . The tables below 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): At June 30, 2020 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents (1) $ 363,019 $ 363,019 $ — $ — Corporate debt securities (2) 1,150,959 — 1,150,959 — Debt securities issued by U.S. government agencies (3) 259,505 — 259,505 — Debt securities issued by the U.S. Treasury (4) 385,651 385,651 — — Debt securities issued by states of the U.S. and political subdivisions of the states (5) 119,744 — 119,744 — Other municipal debt securities (3) 909 — 909 — Investment in ProQR Therapeutics N.V. (6) 2,390 684 — 1,706 Total $ 2,282,177 $ 749,354 $ 1,531,117 $ 1,706 At December 31, 2019 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents (1) $ 418,406 $ 418,406 $ — $ — Corporate debt securities (7) 1,102,568 — 1,102,568 — Debt securities issued by U.S. government agencies (8) 329,404 — 329,404 — Debt securities issued by the U.S. Treasury (3) 363,694 363,694 — — Debt securities issued by states of the U.S. and political subdivisions of the states (3) 40,407 — 40,407 — Investment in ProQR Therapeutics N.V. (6) 4,506 — — 4,506 Total $ 2,258,985 $ 782,100 $ 1,472,379 $ 4,506 The following footnotes reference lines on our condensed consolidated balance sheet: (1) Included in cash and cash equivalents. (2) $32.4 million was included in cash and cash equivalents, with the difference included in short-term investments. (3) Included in short-term investments. (4) $59.7 million was included in cash and cash equivalents, with the difference included in short-term investments. (5) $6.2 million was included in cash and cash equivalents, with the difference included in short-term investments. (6) Included in other current assets. (7) $19.0 million was included in cash and cash equivalents, with the difference included in short-term investments. (8) $0.8 million was included in cash and cash equivalents, with the difference included in short-term investments. Convertible Notes Our 1% Notes and 0.125% Notes had a fair value of $340.5 million and $536.5 million at June 30, 2020, respectively. 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. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2020 | |
Income Taxes [Abstract] | |
Income Taxes | 5. Income Taxes The Coronavirus Aid, Relief, and Economic Security, or CARES, Act was enacted in March 2020. We considered our ability to estimate annual effective tax rates based on our pre-tax income projections, the income tax effects of the CARES Act, the realizability of our net deferred tax assets and the appropriateness of our valuation allowances. Under the Tax Cut and Jobs Act of 2017, the utilization of federal net operating losses was limited to 80 percent of taxable income. The CARES Act temporarily removed this limitation and provides for the utilization of net operating loss carryforwards to offset 100 percent of taxable income. The 80 percent limitation enacted by the Tax Act is reinstated for tax years beginning in 2021. In 2019, we recorded income tax expense related to Akcea due to the 80 percent limitation on the utilization of net operating losses in effect at the time. As a result of the temporary change in tax law provided by the CARES Act, we recorded a $1.7 million tax benefit in the first quarter of 2020 as we will now utilize federal net operating loss carryforwards to offset 100 percent of Akcea’s taxable income for 2019. We recorded the tax benefit as a discrete item in the first quarter of 2020 because that was when the CARES Act was enacted. We recorded an income tax benefit of $0.4 million and $3.7 million for the three and six months ended June 30, 2020, respectively, compared to an income tax benefit of $6.9 million and income tax expense of $24.1 million for the same periods in 2019. We recorded an income tax benefit for the first half of 2020 primarily due to Ionis’ pre-tax loss for the period and the $1.7 million tax benefit related to Akcea. We did not record a tax benefit as a result of Akcea’s pre-tax loss in the first half of 2020 because Akcea maintains a full valuation allowance against its deferred tax assets. Our effective tax rate may vary from the U.S. federal statutory rate due to the change in the mix of earnings in tax jurisdictions with different statutory rates, benefits related to tax credits, the tax impact of non-deductible expenses and other permanent differences between income before taxes and taxable income, and changes to tax laws or rates. Our effective income tax rate of 3.5 percent for the six months ended June 30, 2020 differed from the U.S. federal statutory rate of 21 percent primarily due to Ionis’ pre-tax loss for the period and the $1.7 million tax benefit related to Akcea. |
Collaborative Arrangements and
Collaborative Arrangements and Licensing Agreements | 6 Months Ended |
Jun. 30, 2020 | |
Collaborative Arrangements and Licensing Agreements [Abstract] | |
Collaborative Arrangements and Licensing Agreements | 6. Collaborative Arrangements and Licensing Agreements Below, we have included our collaborations with substantive changes during the first six months of 2020 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, 2019. 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 new antisense medicines for the treatment of SMA We and Biogen are currently developing medicines to treat neurodegenerative diseases under these collaborations, including medicines to treat people with ALS, Alzheimer’s disease and Parkinson’s disease. In addition to these medicines, our collaborations with Biogen include a substantial research pipeline that addresses a broad range of neurological diseases. From inception through June 2020, we have received more than $ billion from our Biogen collaborations. During the three and six months ended June 30, 2020 and 2019, we earned the following revenue from our relationship with Biogen (in millions, except percentage amounts): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 SPINRAZA royalties (commercial revenue) $ 71.7 $ 70.5 $ 137.8 $ 130.2 R&D revenue 26.0 31.9 47.4 56.4 Total revenue from our relationship with Biogen $ 97.7 $ 102.4 $ 185.2 $ 186.6 Percentage of total revenue 67 % 63 % 66 % 41 % During the first six months of 2020, we did not have any changes to our performance obligations or the timing in which we expect to recognize revenue under our Biogen collaborations, except as noted below. Our condensed consolidated balance sheet at June 30, 2020 and December 31, 2019 2012 Neurology In the first quarter of 2020, we achieved a $7.5 million milestone payment from Biogen when we advanced IONIS-MAPT Rx Rx Rx Rx Rx In August 2020, we achieved a $ million milestone payment from Biogen when we advanced IONIS-MAPT Rx . We will achieve the next payment of up to $ million if we continue to advance IONIS-MAPT Rx . 2013 Strategic Neurology In July 2020, we achieved $18 million in milestone payments from Biogen when Biogen initiated a Phase 1/2 trial for ION464, a medicine targeting alpha-synuclein to treat patients with multiple system atrophy. We will achieve the next payment of up to $10 million if Biogen advances one of the medicines under this collaboration. Research, Development and Commercialization Partners AstraZeneca We have two collaborations with AstraZeneca, one focused on the treatment of cardiovascular, renal and metabolic diseases and a second nonalcoholic steatohepatitis, or NASH and cancer During the three and six months ended June 30, 2020 and 2019, we earned the following revenue from our relationship with AstraZeneca (in millions, except percentage amounts): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 R&D revenue $ 16.8 $ 3.8 $ 30.5 $ 7.8 Percentage of total revenue 12 % 2 % 11 % 2 % Our and included deferred revenue of $ million and $ million, respectively, related to our relationship with AstraZeneca. During the first six months of 2020, we did not have any changes to our performance obligations or the timing in which we expect to recognize revenue under our AstraZeneca collaborations, except as noted below. Cardiovascular, Renal and Metabolic Diseases Collaboration In the first quarter of 2020, we achieved a $10 million milestone payment from AstraZeneca when AstraZeneca advanced ION532, a medicine targeting APOL1 for the treatment of kidney disease, in development. We concluded that this milestone payment was not related to our R&D services performance obligation. Therefore, we recognized the $ million milestone payment in full in the first quarter of 2020 because we did not have any performance obligations related to this payment. will achieve the next payment of up to $ million if AstraZeneca advances a medicine under this collaboration. Oncology Collaboration In the second quarter of 2020, we earned a $13 million license fee when AstraZeneca licensed ION736, a medicine targeting FOXP3 to treat cancer. We determined that the license was distinct from our other performance obligations. We recognized the license fee for ION736 as revenue in the second quarter of 2020 because AstraZeneca 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 AstraZeneca in the second quarter of 2020. will achieve the next payment of $ million when AstraZeneca advances ION736 in development. Janssen Biotech, Inc. We have a collaboration with Janssen Biotech, Inc. to discover and develop antisense drugs that can be locally administered, including oral delivery, to treat immune-mediated diseases of the gastrointestinal tract, or GI. Janssen is currently advancing ION253, a medicine for the treatment of immune-mediated GI disease, under this collaboration. In July 2020, we achieved a $5 million milestone payment from Janssen when Janssen initiated a Phase 1 trial for ION253. We will achieve the next payment of $5 million if Janssen advances ION253 in development. |
Segment Information
Segment Information | 6 Months Ended |
Jun. 30, 2020 | |
Segment Information [Abstract] | |
Segment Information | 7. Segment Information We have reportable segments, Ionis Core and Akcea Therapeutics. 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 . Akcea generates revenue from TEGSEDI and WAYLIVRA product sales and from its collaborations. The following tables show our segment revenue and income (loss) from operations for the three and six months ended June 30, 2020 and 2019 (in thousands), respectively. Three Months Ended June 30, 2020 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 71,746 $ — $ — $ 71,746 Product sales, net — 16,364 — 16,364 Licensing and other royalty revenue 2,237 — (613 ) 1,624 Total commercial revenue 73,983 16,364 (613 ) 89,734 R&D revenue under collaborative agreements 55,070 6,013 (5,280 ) 55,803 Total segment revenue $ 129,053 $ 22,377 $ (5,893 ) $ 145,537 Total operating expenses $ 131,177 $ 73,468 $ (7,354 ) $ 197,291 Loss from operations $ (2,124 ) $ (51,091 ) $ 1,461 $ (51,754 ) Three Months Ended June 30, 2019 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 70,502 $ — $ — $ 70,502 Product sales, net — 9,865 — 9,865 Licensing and other royalty revenue 4,896 6,036 (3,000 ) 7,932 Total commercial revenue 75,398 15,901 (3,000 ) 88,299 R&D revenue under collaborative agreements 64,791 10,723 — 75,514 Total segment revenue $ 140,189 $ 26,624 $ (3,000 ) $ 163,813 Total operating expenses $ 121,774 $ 65,328 $ (4,462 ) $ 182,640 Income (loss) from operations $ 18,415 $ (38,704 ) $ 1,462 $ (18,827 ) Six Months Ended June 30, 2020 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 137,754 $ — $ — $ 137,754 Product sales, net — 31,523 — 31,523 Licensing and other royalty revenue 5,835 — (1,416 ) 4,419 Total commercial revenue 143,589 31,523 (1,416 ) 173,696 R&D revenue under collaborative agreements 103,561 6,928 (5,280 ) 105,209 Total segment revenue $ 247,150 $ 38,451 $ (6,696 ) $ 278,905 Total operating expenses $ 266,602 $ 134,800 $ (9,618 ) $ 391,784 Loss from operations $ (19,452 ) $ (96,349 ) $ 2,922 $ (112,879 ) Six Months Ended June 30, 2019 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 130,212 $ — $ — $ 130,212 Product sales, net — 16,619 — 16,619 Licensing and other royalty revenue 6,519 6,036 (3,000 ) 9,555 Total commercial revenue 136,731 22,655 (3,000 ) 156,386 R&D revenue under collaborative agreements 225,347 167,785 (88,492 ) 304,640 Total segment revenue $ 362,078 $ 190,440 $ (91,492 ) $ 461,026 Total operating expenses $ 236,290 $ 202,938 $ (80,908 ) $ 358,320 Income (loss) from operations $ 125,788 $ (12,498 ) $ (10,584 ) $ 102,706 The following table shows our total assets by segment at June 30, 2020 and December 31, 2019 (in thousands), respectively. Total Assets Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total June 30, 2020 $ 3,397,604 $ 527,937 $ (846,591 ) $ 3,078,950 December 31, 2019 $ 3,478,081 $ 599,250 $ (844,219 ) $ 3,233,112 |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | We prepared the unaudited interim condensed consolidated financial statements for the three and six months ended June 30, 2020 and 2019 on the same basis as the audited financial statements for the year ended December 31, 2019. 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. Our operating results for the interim periods may not be indicative of what our operating results will be 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, 2019 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. initial public offering, or IPO. Since Akcea’s IPO, our ownership has ranged from to . Rx |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Significant Accounting Policies [Abstract] | |
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 condensed consolidated balance sheet. Commercial Revenue: SPINRAZA royalties and Licensing and other royalty revenue We earn commercial revenue primarily in the form of royalty payments on net sales of SPINRAZA. We will also recognize as commercial revenue sales milestone payments and royalties we earn in the future under our partnerships. Commercial Revenue: Product sales, net We added product sales from TEGSEDI to our commercial revenue in the fourth quarter of 2018 and we added product sales from WAYLIVRA to our commercial revenue in the third quarter of 2019. 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. In Note 6, Collaborative Arrangements and Licensing Agreements 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: 1. Identify the contract First we determine if we have a contract with our partner, including confirming that we have met each of the following criteria: ● 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 of the consideration is probable. 2. Identify the performance obligations We next identify our performance obligations, which represent the distinct goods and services we are required to provide under the contract. 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 because 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 material performance obligations related to the license after delivery, then we consider the license to be a separate performance obligation. 3. Determine the transaction price 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 future 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 2020, we earned a $10 million milestone payment from AstraZeneca when AstraZeneca advanced ION532 targeting APOL1 for the treatment of kidney disease under our cardiovascular, renal and metabolic diseases collaboration 4. Allocate the transaction price 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 do not reallocate the transaction price after the start of an agreement to reflect subsequent changes in stand-alone selling prices. 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: ● Estimated future product sales; ● Estimated royalties we may receive from future product sales; ● Estimated contractual milestone payments we may receive; ● Expenses we expect to incur; ● Income taxes; and ● A discount rate. 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: ● 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. 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. 5. Recognize revenue 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. For example, 2013 Strategic Neurology collaboration with Biogen significant portion of the research and development services. In this example, we expected to complete the remainder of our services in 2020. As a result of our change in estimate, in the third quarter of 2019, we recorded a cumulative catch up adjustment of $ million to decrease revenue. Refer to Note 6, Collaborative Arrangements and Licensing Agreements , for further discussion of the cumulative catch up adjustment we made in 2019. 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, including royalties from SPINRAZA sales, in the period in which the counterparty sells the related product and recognizes the related revenue, which in certain cases may require us to estimate our royalty revenue. Commercial Revenue: Product sales, net We recognize product sales in the period Reserves for Product sales We record 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 a reduction of accounts receivable when we are not required to make a payment or as a current liability when we are required to make a payment. 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 product sales in the respective period. The following are the components of variable consideration related to product sales: Chargebacks: Government rebates : We are subject t Managed care rebates: Trade discounts: Distribution services Product returns: Other incentives: 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-L Rx for the treatment of complement-mediated diseases 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. 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 in which 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 first quarter of 2020, we achieved a $7.5 million milestone payment from Biogen when we advanced IONIS-MAPT Rx Rx 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 2020, we recognized a $10 million milestone payment when AstraZeneca advanced ION532 targeting APOL1 for the treatment of kidney disease under our cardiovascular, renal and metabolic diseases collaboration agreement We concluded that the milestone payment was not related to our R&D services performance obligation. Therefore, we recognized the milestone payment in full in the first quarter of 2020. License fees We generally recognize as revenue the total amount we determine to be the relative 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. Sublicense fees We recognize sublicense fee revenue in the period in which a party, who has already licensed our technology, further licenses the technology to another party because we do not have any performance obligations related to the sublicense. 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: 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. 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-FXI Rx for the prevention of thrombosis. As part of the agreement, Bayer paid us a $ million upfront payment. At the onset of the agreement, we were responsible for completing a Phase 2 study of IONIS-FXI Rx 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-FXI Rx and to initiate development of IONIS-FXI-L Rx , which Bayer licensed. As part of the 2017 amendment, Bayer paid us $ million. We are also eligible to receive milestone payments and tiered royalties on gross margins of IONIS-FXI Rx and IONIS-FXI-L Rx . Under the 2017 amendment, we concluded we had a new agreement with performance obligations. These performance obligations were to deliver the license of IONIS-FXI-L Rx , to provide R&D services and to deliver API. We allocated the $ million transaction price to these performance obligations. Refer to Note 6, Collaborative Arrangements and Licensing Agreements , for further discussion of the 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: ● 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. 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 | 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 | 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. |
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. |
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 our products. We also may include certain period costs related to manufacturing services and inventory adjustments in cost of products sold. Prior to obtaining regulatory approval of TEGSEDI in July 2018 and WAYLIVRA in May 2019, we expensed as research and development expenses a significant portion of the costs we incurred to produce the initial commercial launch supply for each medicine. |
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. Since Akcea’s IPO, our ownership has ranged from to . ● 2.8 million shares in the first quarter of 2019 as payment for the sublicense fee Akcea owed us for Novartis’s license of AKCEA-APO(a)-L Rx ● 6.9 million shares in the fourth quarter of 2019 as payment for the sublicense fee Akcea owed us for Pfizer’s license of vupanorsen. The shares third parties own represent an interest in Akcea’s equity that we do control. 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 | 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 June 30, 2020, 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 five privately-held companies, Atlantic Pharmaceuticals Limited, Dynacure SAS, Empirico, Inc., Seventh Sense Biosystems and Suzhou Ribo Life Science Co, Ltd. We are required to measure and record our equity investments at fair value and to recognize the changes in fair value in our condensed consolidated statement of operations. We account for our equity investments in privately held companies at their cost minus impairments, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer. For example, during the second quarter of 2020, we revalued our investments in two privately-held companies, Dynacure and Ribo because the companies sold additional equity securities that were similar to those we own. These observable price changes resulted in us recognizing a $6.3 million gain on our investment in Dynacure and a $3 million gain on our investment in Ribo in our condensed consolidated statement of operations during the three months ended June 30, 2020. |
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, which we refer to as clinical raw materials. 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 and for WAYLIVRA in May 2019. At June 30, 2020, our physical inventory for TEGSEDI and WAYLIVRA included API that we produced prior to when we obtained regulatory approval. As such, this API 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 material inventory write-offs for the . Total inventory was $ million and $ million as of , respectively, and June 30, 2020 December 31, 2019 Raw materials: Raw materials- clinical $ 9,967 $ 9,363 Raw materials- commercial 9,543 6,520 Total raw materials 19,510 15,883 Work in process 3,471 2,039 Finished goods 741 258 Total inventory $ 23,722 $ 18,180 |
Leases | 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. As our current leases do not provide an interest rate implicit in the lease, we used our incremental borrowing rate, based on the information available on the date we adopted Topic 842 (January 2019) or as of the lease inception date in determining the present value of future payments. 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 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. |
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 U.S. Patent and Trademark Office, or foreign equivalent, issues the patent. . |
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. |
Long-Lived Assets | Long-lived Assets We evaluate long-lived assets, which include property, plant and equipment and patent costs, 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 | Use of Estimates The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the |
Basic and Diluted Net Income (Loss) per Share | Basic and Diluted Net Income (Loss) Per Share Basic net income (loss) per share We compute basic net income (loss) per share by dividing the total net income (loss) attributable to our common stockholders by our weighted-average number of common shares outstanding during the period. The calculation of total net income (loss) attributable to our common stockholders for the three and six months ended June 30, 2020 and 2019 considered our net income (loss) for Ionis on a stand-alone basis plus our share of Akcea’s net income (loss) for the period. To calculate the portion of Akcea’s net loss attributable to our ownership, we multiplied Akcea’s net income (loss) per share by the weighted average shares we owned in Akcea during the period. As a result of this calculation, our total net income (loss) available to Ionis common stockholders for the calculation of net income (loss) per share is different than net income (loss) attributable to Ionis Pharmaceuticals, Inc. common stockholders in the condensed consolidated statements of operations. Our basic net loss per share for the three months ended June 30, 2020, was calculated as follows (in thousands, except per share amounts): Three months ended June 30, 2020 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Basic Net Loss Per Share Calculation Ionis’ portion of Akcea’s net loss 77,095 $ (0.49 ) $ (37,665 ) Akcea’s net loss attributable to our ownership $ (37,665 ) Ionis’ stand-alone net income 5,807 Net loss available to Ionis common stockholders $ (31,858 ) Weighted average shares outstanding 139,352 Basic net loss per share $ (0.23 ) Our basic net loss per share for the six months ended Six months ended June 30, 2020 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Basic Net Loss Per Share Calculation Ionis’ portion of Akcea’s net loss 77,095 $ (0.91 ) $ (70,348 ) Akcea’s net loss attributable to our ownership $ (70,348 ) Ionis’ stand-alone net loss (9,822 ) Net loss available to Ionis common stockholders $ (80,170 ) Weighted average shares outstanding 139,391 Basic net loss per share $ (0.58 ) Our basic net loss per share for the three months ended June 30, 2019, was calculated as follows (in thousands, except per share amounts): Three months ended June 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Income Per Share Basic Net Loss Per Share Calculation Ionis’ portion of Akcea’s net loss 70,221 $ (0.40 ) $ (28,244 ) Akcea’s net loss attributable to our ownership $ (28,244 ) Ionis’ stand-alone net income 27,311 Net loss available to Ionis common stockholders $ (933 ) Weighted average shares outstanding 140,247 Basic net loss per share $ (0.01 ) Our basic net income per share for the six months ended Six months ended June 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Basic Net Income Per Share Calculation Ionis’ portion of Akcea’s net loss 69,406 $ (0.06 ) $ (4,380 ) Akcea’s net loss attributable to our ownership $ (4,380 ) Ionis’ stand-alone net income 91,008 Net income available to Ionis common stockholders $ 86,628 Weighted average shares outstanding 139,419 Basic net income per share $ 0.62 Diluted net income (loss) per share For the three and six months ended June 30, 2020 and the three months ended June 30, 2019, 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: ● 0.125 percent convertible senior notes (for the three and six months ended June 30, 2020); ● 1 percent convertible senior notes; ● Dilutive stock options; ● Unvested restricted stock units; and ● Employee Stock Purchase Plan, or ESPP. For the six months ended June 30, 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 six months ended June 30, 2019 as follows (in thousands except per share amounts): Six months ended June 30, 2019 Income (Numerator) Shares (Denominator) Per-Share Amount Net income available to Ionis common stockholders $ 86,628 139,419 $ 0.62 Effect of dilutive securities: Shares issuable upon exercise of stock options — 2,327 Shares issuable upon restricted stock award issuance — 745 Shares issuable related to our Employee Stock Purchase Plan — 8 Income available to Ionis common stockholders $ 86,628 142,499 $ 0.61 For the six months ended June 30, 2019, the calculation excluded our 1 percent convertible senior notes, or 1% Notes, because the effect on diluted earnings per share was anti-dilutive. For the six months ended June 30, 2019, we did not have our 0.125 percent convertible senior notes. |
Convertible Debt | Convertible Debt At issuance, we accounted for our convertible debt instruments, including our senior convertible notes, or Notes, and Notes 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 on the date the notes were issued. In reviewing debt issuances, we were not able to identify any comparable companies that issued non-convertible debt instruments at the time of the issuance of the convertible notes. Therefore, we estimated the fair value of the liability component of our notes by using assumptions that market participants would use in pricing a debt instrument, including market interest rates, credit standing, yield curves and volatilities. 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 | Segment Information We have operating segments, our Ionis Core segment and Akcea Therapeutics, our majority-owned affiliate. Akcea is . 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 and we bill Akcea for these expenses. |
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 six months ended June 30, 2020 and 2019, we used the following weighted-average assumptions in our Black-Scholes calculations: Ionis Employee Stock Options: Six Months Ended June 30, 2020 2019 Risk-free interest rate 1.6 % 2.4 % Dividend yield 0.0 % 0.0 % Volatility 58.9 % 60.3 % Expected life 4.7 years 4.6 years Ionis ESPP: Six Months Ended June 30, 2020 2019 Risk-free interest rate 1.1 % 2.5 % Dividend yield 0.0 % 0.0 % Volatility 47.2 % 45.5 % Expected life 6 months 6 months Ionis RSU’s: 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 six months ended June 30, 2020 was $64.31 per share. In addition to our stock plans, Akcea has its own stock plan under which it grants stock 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 six months ended Akcea Employee Stock Options: Six Months Ended June 30, 2020 2019 Risk-free interest rate 1.3 % 2.5 % Dividend yield 0.0 % 0.0 % Volatility 74.5 % 76.3 % Expected life 6.1 years 6.1 years Akcea Board of Directors Stock Options: Six Months Ended June 30 2020 2019 Risk-free interest rate 0.8 % 1.9 % Dividend yield 0.0 % 0.0 % Volatility 75.3 % 74.3 % Expected life 5.7 years 6.3 years Akcea ESPP: Six Months Ended June 30, 2020 2019 Risk-free interest rate 1.0 % 2.5 % Dividend yield 0.0 % 0.0 % Volatility 71.9 % 64.1 % Expected life 6 months 6 months Akcea RSU’s: The fair value of RSUs is based on the market price of Akcea’s common stock on the date of grant. Akcea has granted RSUs with various vesting terms between six months and four years. The weighted-average grant date fair value of RSUs granted to employees for the six months ended June 30, 2020 was $15.76 per share. The following table summarizes stock-based compensation expense for the three and six months ended June 30, 2020 and 2019 (in thousands). Our non-cash stock-based compensation expense included $16.1 million and $23.4 million of stock-based compensation expense for Akcea employees for the three and six months ended June 30, 2020, respectively, compared to $14.4 million and $32.9 million for the same periods in 2019. Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Cost of products sold $ 350 $ 137 $ 587 $ 255 Research, development and patent 26,016 23,756 51,573 48,191 Selling, general and administrative 22,076 18,040 37,073 38,991 Total non-cash stock-based compensation expense $ 48,442 $ 41,933 $ 89,233 $ 87,437 As of June 30, 2020, total unrecognized estimated non-cash stock-based compensation expense related to non-vested stock options and RSUs was $137.8 million and $103.7 million, respectively. Our actual expenses may differ from these estimates because we will adjust our unrecognized non-cash stock-based compensation expense for future forfeitures. We expect to recognize the cost of non-cash stock-based compensation expense related to non-vested stock options and RSUs over a weighted average amortization period of 1.3 years and 1.7 years, respectively. |
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. We adopted this new guidance on January 1, 2020. This guidance did not have an impact on our condensed consolidated financial statements. 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. We adopted this guidance on January 1, 2020 on a prospective basis. This guidance did not have an impact on our condensed consolidated financial statements. 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 implemented it (in italics): 1) When a participant is considered a customer in a collaborative arrangement, all of the associated accounting under Topic 606 should be applied ● We are applying 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 use the “unit of account” concept when we receive consideration under a collaborative arrangement 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 do not recognize revenue for the transaction We adopted this new guidance on January 1, 2020. This guidance did not have a significant impact on our condensed consolidated financial statements. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Significant Accounting Policies [Abstract] | |
Inventory | 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 material inventory write-offs for the . Total inventory was $ million and $ million as of , respectively, and June 30, 2020 December 31, 2019 Raw materials: Raw materials- clinical $ 9,967 $ 9,363 Raw materials- commercial 9,543 6,520 Total raw materials 19,510 15,883 Work in process 3,471 2,039 Finished goods 741 258 Total inventory $ 23,722 $ 18,180 |
Basic Net Income per Share | Our basic net loss per share for the three months ended June 30, 2020, was calculated as follows (in thousands, except per share amounts): Three months ended June 30, 2020 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Basic Net Loss Per Share Calculation Ionis’ portion of Akcea’s net loss 77,095 $ (0.49 ) $ (37,665 ) Akcea’s net loss attributable to our ownership $ (37,665 ) Ionis’ stand-alone net income 5,807 Net loss available to Ionis common stockholders $ (31,858 ) Weighted average shares outstanding 139,352 Basic net loss per share $ (0.23 ) Our basic net loss per share for the six months ended Six months ended June 30, 2020 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Basic Net Loss Per Share Calculation Ionis’ portion of Akcea’s net loss 77,095 $ (0.91 ) $ (70,348 ) Akcea’s net loss attributable to our ownership $ (70,348 ) Ionis’ stand-alone net loss (9,822 ) Net loss available to Ionis common stockholders $ (80,170 ) Weighted average shares outstanding 139,391 Basic net loss per share $ (0.58 ) Our basic net loss per share for the three months ended June 30, 2019, was calculated as follows (in thousands, except per share amounts): Three months ended June 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Income Per Share Basic Net Loss Per Share Calculation Ionis’ portion of Akcea’s net loss 70,221 $ (0.40 ) $ (28,244 ) Akcea’s net loss attributable to our ownership $ (28,244 ) Ionis’ stand-alone net income 27,311 Net loss available to Ionis common stockholders $ (933 ) Weighted average shares outstanding 140,247 Basic net loss per share $ (0.01 ) Our basic net income per share for the six months ended Six months ended June 30, 2019 Weighted Average Shares Owned in Akcea Akcea’s Net Loss Per Share Basic Net Income Per Share Calculation Ionis’ portion of Akcea’s net loss 69,406 $ (0.06 ) $ (4,380 ) Akcea’s net loss attributable to our ownership $ (4,380 ) Ionis’ stand-alone net income 91,008 Net income available to Ionis common stockholders $ 86,628 Weighted average shares outstanding 139,419 Basic net income per share $ 0.62 |
Basic and Diluted Net Income Per Share | We calculated our diluted net income per share for the six months ended June 30, 2019 as follows (in thousands except per share amounts): Six months ended June 30, 2019 Income (Numerator) Shares (Denominator) Per-Share Amount Net income available to Ionis common stockholders $ 86,628 139,419 $ 0.62 Effect of dilutive securities: Shares issuable upon exercise of stock options — 2,327 Shares issuable upon restricted stock award issuance — 745 Shares issuable related to our Employee Stock Purchase Plan — 8 Income available to Ionis common stockholders $ 86,628 142,499 $ 0.61 |
Significant Accounting Policies [Abstract] | |
Weighted-Average Assumptions for Stock Options | Ionis Employee Stock Options: Six Months Ended June 30, 2020 2019 Risk-free interest rate 1.6 % 2.4 % Dividend yield 0.0 % 0.0 % Volatility 58.9 % 60.3 % Expected life 4.7 years 4.6 years |
Weighted-Average Assumptions for ESPP | Ionis ESPP: Six Months Ended June 30, 2020 2019 Risk-free interest rate 1.1 % 2.5 % Dividend yield 0.0 % 0.0 % Volatility 47.2 % 45.5 % Expected life 6 months 6 months |
Stock-Based Compensation Expense | The following table summarizes stock-based compensation expense for the three and six months ended June 30, 2020 and 2019 (in thousands). Our non-cash stock-based compensation expense included $16.1 million and $23.4 million of stock-based compensation expense for Akcea employees for the three and six months ended June 30, 2020, respectively, compared to $14.4 million and $32.9 million for the same periods in 2019. Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 Cost of products sold $ 350 $ 137 $ 587 $ 255 Research, development and patent 26,016 23,756 51,573 48,191 Selling, general and administrative 22,076 18,040 37,073 38,991 Total non-cash stock-based compensation expense $ 48,442 $ 41,933 $ 89,233 $ 87,437 |
Akcea [Member] | |
Significant Accounting Policies [Abstract] | |
Weighted-Average Assumptions for Stock Options | Akcea Employee Stock Options: Six Months Ended June 30, 2020 2019 Risk-free interest rate 1.3 % 2.5 % Dividend yield 0.0 % 0.0 % Volatility 74.5 % 76.3 % Expected life 6.1 years 6.1 years Akcea Board of Directors Stock Options: Six Months Ended June 30 2020 2019 Risk-free interest rate 0.8 % 1.9 % Dividend yield 0.0 % 0.0 % Volatility 75.3 % 74.3 % Expected life 5.7 years 6.3 years |
Weighted-Average Assumptions for ESPP | Akcea ESPP: Six Months Ended June 30, 2020 2019 Risk-free interest rate 1.0 % 2.5 % Dividend yield 0.0 % 0.0 % Volatility 71.9 % 64.1 % Expected life 6 months 6 months |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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 June 30, 2020: One year or less 69 % After one year but within two years 23 % After two years but within three years 8 % Total 100 % |
Summary of Investments | The following is a summary of our investments (in thousands): Gross Unrealized Estimated June 30, 2020 Cost Gains Losses Fair Value Available-for-sale securities: Corporate debt securities (2) $ 652,555 $ 4,275 $ (17 ) $ 656,813 Debt securities issued by U.S. government agencies 139,810 673 (9 ) 140,474 Debt securities issued by the U.S. Treasury (2) 325,925 815 (7 ) 326,733 Debt securities issued by states of the U.S. and political subdivisions of the states 68,651 214 (3 ) 68,862 Other municipal debt securities 902 7 — 909 Total securities with a maturity of one year or less 1,187,843 5,984 (36 ) 1,193,791 Corporate debt securities 485,487 8,780 (121 ) 494,146 Debt securities issued by U.S. government agencies 118,538 521 (28 ) 119,031 Debt securities issued by the U.S. Treasury 58,334 588 (4 ) 58,918 Debt securities issued by states of the U.S. and political subdivisions of the states 50,514 371 (3 ) 50,882 Total securities with a maturity of more than one year 712,873 10,260 (156 ) 722,977 Total available-for-sale securities $ 1,900,716 $ 16,244 $ (192 ) $ 1,916,768 Equity securities: Total equity securities included in other current assets (3) $ 4,712 $ — $ (2,322 ) $ 2,390 Total equity securities included in deposits and other assets (4) 15,019 9,318 — 24,337 Total equity securities 19,731 9,318 (2,322 ) 26,727 Total available-for-sale and equity securities $ 1,920,447 $ 25,562 $ (2,514 ) $ 1,943,495 Gross Unrealized Estimated December 31, 2019 Cost Gains Losses Fair Value Available-for-sale securities: Corporate debt securities (2) $ 669,665 $ 1,451 $ (43 ) $ 671,073 Debt securities issued by U.S. government agencies 188,216 303 (43 ) 188,476 Debt securities issued by the U.S. Treasury (2) 327,670 232 (27 ) 327,875 Debt securities issued by states of the U.S. and political subdivisions of the states (2) 21,065 26 (5 ) 21,086 Total securities with a maturity of one year or less 1,206,616 2,012 (118 ) 1,208,510 Corporate debt securities 428,627 2,911 (43 ) 431,495 Debt securities issued by U.S. government agencies 140,988 57 (117 ) 140,928 Debt securities issued by the U.S. Treasury 35,822 9 (12 ) 35,819 Debt securities issued by states of the U.S. and political subdivisions of the states 19,309 18 (6 ) 19,321 Total securities with a maturity of more than one year 624,746 2,995 (178 ) 627,563 Total available-for-sale securities $ 1,831,362 $ 5,007 $ (296 ) $ 1,836,073 Equity securities: Total equity securities included in other current assets (3) 4,712 — (870 ) 3,842 Total equity securities included in deposits and other assets (4) 10,000 — — 10,000 Total equity securities 14,712 — (870 ) 13,842 Total available-for-sale and equity securities $ 1,846,074 $ 5,007 $ (1,166 ) $ 1,849,915 (1) We hold our available-for-sale securities at amortized cost. (2) Includes investments classified as cash equivalents on our condensed consolidated balance sheet. (3) Our equity securities included in other current assets consisted of our investments in publicly-traded companies. We recognize publicly-traded equity securities at fair value. (4) Our equity securities included in deposits and other assets consisted of our investments in privately-held companies. We recognize our private company equity securities at on our condensed consolidated balance sheet. |
Temporarily Impaired Investments | The following is a summary of our investments we consider to be temporarily impaired at (in thousands). 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. Less than 12 Months of Temporary Impairment More than 12 Months of Temporary Impairment Total Temporary Impairment Number of Investments Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Estimated Fair Value Unrealized Losses Corporate debt securities 37 $ 87,460 $ (138 ) $ — $ — $ 87,460 $ (138 ) Debt securities issued by U.S. government agencies 10 44,389 (33 ) 26,997 (4 ) 71,386 (37 ) Debt securities issued by the U.S. Treasury 9 110,067 (11 ) — — 110,067 (11 ) Debt securities issued by states of the U.S. and political subdivisions of the states 22 7,763 (6 ) — — 7,763 (6 ) Total temporarily impaired securities 78 $ 249,679 $ (188 ) $ 26,997 $ (4 ) $ 276,676 $ (192 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Measurements [Abstract] | |
Assets Measured at Fair Value on a Recurring Basis | The following tables present the major security types we held at and that we regularly measure and carry at fair value. At and , subject to trading restrictions that extend to the fourth quarter of 2020; as a result, we The amount we owned in ProQR did not change from to . The tables below 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): At June 30, 2020 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents (1) $ 363,019 $ 363,019 $ — $ — Corporate debt securities (2) 1,150,959 — 1,150,959 — Debt securities issued by U.S. government agencies (3) 259,505 — 259,505 — Debt securities issued by the U.S. Treasury (4) 385,651 385,651 — — Debt securities issued by states of the U.S. and political subdivisions of the states (5) 119,744 — 119,744 — Other municipal debt securities (3) 909 — 909 — Investment in ProQR Therapeutics N.V. (6) 2,390 684 — 1,706 Total $ 2,282,177 $ 749,354 $ 1,531,117 $ 1,706 At December 31, 2019 Quoted Prices in Active Markets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Cash equivalents (1) $ 418,406 $ 418,406 $ — $ — Corporate debt securities (7) 1,102,568 — 1,102,568 — Debt securities issued by U.S. government agencies (8) 329,404 — 329,404 — Debt securities issued by the U.S. Treasury (3) 363,694 363,694 — — Debt securities issued by states of the U.S. and political subdivisions of the states (3) 40,407 — 40,407 — Investment in ProQR Therapeutics N.V. (6) 4,506 — — 4,506 Total $ 2,258,985 $ 782,100 $ 1,472,379 $ 4,506 The following footnotes reference lines on our condensed consolidated balance sheet: (1) Included in cash and cash equivalents. (2) $32.4 million was included in cash and cash equivalents, with the difference included in short-term investments. (3) Included in short-term investments. (4) $59.7 million was included in cash and cash equivalents, with the difference included in short-term investments. (5) $6.2 million was included in cash and cash equivalents, with the difference included in short-term investments. (6) Included in other current assets. (7) $19.0 million was included in cash and cash equivalents, with the difference included in short-term investments. (8) $0.8 million was included in cash and cash equivalents, with the difference included in short-term investments. |
Collaborative Arrangements an_2
Collaborative Arrangements and Licensing Agreements (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Biogen [Member] | |
Collaborative Arrangements and Licensing Agreements [Abstract] | |
Revenue from Collaborative Relationship | During the three and six months ended June 30, 2020 and 2019, we earned the following revenue from our relationship with Biogen (in millions, except percentage amounts): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 SPINRAZA royalties (commercial revenue) $ 71.7 $ 70.5 $ 137.8 $ 130.2 R&D revenue 26.0 31.9 47.4 56.4 Total revenue from our relationship with Biogen $ 97.7 $ 102.4 $ 185.2 $ 186.6 Percentage of total revenue 67 % 63 % 66 % 41 % |
AstraZeneca [Member] | |
Collaborative Arrangements and Licensing Agreements [Abstract] | |
Revenue from Collaborative Relationship | During the three and six months ended June 30, 2020 and 2019, we earned the following revenue from our relationship with AstraZeneca (in millions, except percentage amounts): Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 R&D revenue $ 16.8 $ 3.8 $ 30.5 $ 7.8 Percentage of total revenue 12 % 2 % 11 % 2 % |
Segment Information (Tables)
Segment Information (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Segment Information [Abstract] | |
Segment Information | The following tables show our segment revenue and income (loss) from operations for the three and six months ended June 30, 2020 and 2019 (in thousands), respectively. Three Months Ended June 30, 2020 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 71,746 $ — $ — $ 71,746 Product sales, net — 16,364 — 16,364 Licensing and other royalty revenue 2,237 — (613 ) 1,624 Total commercial revenue 73,983 16,364 (613 ) 89,734 R&D revenue under collaborative agreements 55,070 6,013 (5,280 ) 55,803 Total segment revenue $ 129,053 $ 22,377 $ (5,893 ) $ 145,537 Total operating expenses $ 131,177 $ 73,468 $ (7,354 ) $ 197,291 Loss from operations $ (2,124 ) $ (51,091 ) $ 1,461 $ (51,754 ) Three Months Ended June 30, 2019 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 70,502 $ — $ — $ 70,502 Product sales, net — 9,865 — 9,865 Licensing and other royalty revenue 4,896 6,036 (3,000 ) 7,932 Total commercial revenue 75,398 15,901 (3,000 ) 88,299 R&D revenue under collaborative agreements 64,791 10,723 — 75,514 Total segment revenue $ 140,189 $ 26,624 $ (3,000 ) $ 163,813 Total operating expenses $ 121,774 $ 65,328 $ (4,462 ) $ 182,640 Income (loss) from operations $ 18,415 $ (38,704 ) $ 1,462 $ (18,827 ) Six Months Ended June 30, 2020 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 137,754 $ — $ — $ 137,754 Product sales, net — 31,523 — 31,523 Licensing and other royalty revenue 5,835 — (1,416 ) 4,419 Total commercial revenue 143,589 31,523 (1,416 ) 173,696 R&D revenue under collaborative agreements 103,561 6,928 (5,280 ) 105,209 Total segment revenue $ 247,150 $ 38,451 $ (6,696 ) $ 278,905 Total operating expenses $ 266,602 $ 134,800 $ (9,618 ) $ 391,784 Loss from operations $ (19,452 ) $ (96,349 ) $ 2,922 $ (112,879 ) Six Months Ended June 30, 2019 Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total Revenue: Commercial revenue: SPINRAZA royalties $ 130,212 $ — $ — $ 130,212 Product sales, net — 16,619 — 16,619 Licensing and other royalty revenue 6,519 6,036 (3,000 ) 9,555 Total commercial revenue 136,731 22,655 (3,000 ) 156,386 R&D revenue under collaborative agreements 225,347 167,785 (88,492 ) 304,640 Total segment revenue $ 362,078 $ 190,440 $ (91,492 ) $ 461,026 Total operating expenses $ 236,290 $ 202,938 $ (80,908 ) $ 358,320 Income (loss) from operations $ 125,788 $ (12,498 ) $ (10,584 ) $ 102,706 The following table shows our total assets by segment at June 30, 2020 and December 31, 2019 (in thousands), respectively. Total Assets Ionis Core Akcea Therapeutics Elimination of Intercompany Activity Total June 30, 2020 $ 3,397,604 $ 527,937 $ (846,591 ) $ 3,078,950 December 31, 2019 $ 3,478,081 $ 599,250 $ (844,219 ) $ 3,233,112 |
Basis of Presentation (Details)
Basis of Presentation (Details) - Akcea [Member] - shares shares in Millions | 3 Months Ended | |||
Dec. 31, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2017 | |
Basis of Presentation [Abstract] | ||||
Percentage ownership | 76.00% | 100.00% | ||
Additional shares of Akcea stock received (in shares) | 6.9 | 2.8 | ||
Minimum [Member] | ||||
Basis of Presentation [Abstract] | ||||
Percentage ownership | 68.00% | |||
Maximum [Member] | ||||
Basis of Presentation [Abstract] | ||||
Percentage ownership | 77.00% |
Significant Accounting Polici_4
Significant Accounting Policies, Revenue Recognition (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||
Feb. 28, 2017USD ($)PerformanceObligation | May 31, 2015USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Dec. 31, 2018USD ($) | Jun. 30, 2018Agreement | Jun. 30, 2020USD ($)PerformanceObligation | Jun. 30, 2019USD ($) | |
Revenue Recognition [Abstract] | ||||||||||
Number of performance obligations at inception of contract | PerformanceObligation | 1 | |||||||||
Revenue | $ 145,537 | $ 163,813 | $ 278,905 | $ 461,026 | ||||||
Biogen [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Number of agreements | Agreement | 2 | |||||||||
Licensing and Other Royalty Revenue [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Revenue | 1,624 | 7,932 | $ 4,419 | $ 9,555 | ||||||
Cardiovascular, Renal and Metabolic Diseases [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Revenue | $ 10,000 | |||||||||
2013 Strategic Neurology [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Revenue | $ (16,500) | |||||||||
IONIS-FB-L for Complement-Mediated Diseases [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Upfront payment received | $ 75,000 | |||||||||
2012 Neurology [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Milestone payment earned and amortized over period of performance | $ 7,500 | |||||||||
Oncology [Member] | Licensing and Other Royalty Revenue [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Revenue | $ 13,000 | |||||||||
Alnylam [Member] | Licensing and Other Royalty Revenue [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Revenue | $ 20,000 | |||||||||
Bayer [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Number of separate performance obligations | PerformanceObligation | 3 | |||||||||
Bayer [Member] | ||||||||||
Revenue Recognition [Abstract] | ||||||||||
Upfront payment received | $ 75,000 | $ 100,000 | ||||||||
Transaction price | $ 75,000 |
Significant Accounting Polici_5
Significant Accounting Policies, Contracts Receivable (Details) | 6 Months Ended |
Jun. 30, 2020 | |
Contracts Receivable [Abstract] | |
Period of time after billing when payment is received | 3 months |
Significant Accounting Polici_6
Significant Accounting Policies, Deferred Revenue (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Deferred Revenue [Abstract] | ||||
Revenue recognized from amounts in beginning deferred revenue balance | $ 39.6 | $ 46.9 | $ 61.9 | $ 87.2 |
Significant Accounting Polici_7
Significant Accounting Policies, Noncontrolling Interest in Akcea (Details) - Akcea [Member] - shares shares in Millions | 3 Months Ended | |||
Dec. 31, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2017 | |
Noncontrolling Interest in Akcea Therapeutics, Inc. [Abstract] | ||||
Percentage ownership | 76.00% | 100.00% | ||
Additional shares of Akcea stock received (in shares) | 6.9 | 2.8 | ||
Minimum [Member] | ||||
Noncontrolling Interest in Akcea Therapeutics, Inc. [Abstract] | ||||
Percentage ownership | 68.00% | |||
Maximum [Member] | ||||
Noncontrolling Interest in Akcea Therapeutics, Inc. [Abstract] | ||||
Percentage ownership | 77.00% |
Significant Accounting Polici_8
Significant Accounting Policies, Cash, Cash Equivalents and Investments (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020USD ($)Company | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($)Company | Jun. 30, 2019USD ($) | |
Cash, Cash Equivalents and Investments [Abstract] | ||||
Number of publicly-held companies in which there is an equity ownership interest of less than 20% | Company | 2 | 2 | ||
Number of privately-held companies in which there is an equity ownership interest of less than 20% | Company | 5 | 5 | ||
Gain on investment | $ | $ 9,625 | $ 0 | $ 9,887 | $ 0 |
Dynacure SAS [Member] | ||||
Cash, Cash Equivalents and Investments [Abstract] | ||||
Gain on investment | $ | $ 6,300 |
Significant Accounting Polici_9
Significant Accounting Policies, Inventory Valuation (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Inventory Valuation [Abstract] | ||
Raw materials | $ 19,510 | $ 15,883 |
Work-in-process | 3,471 | 2,039 |
Finished goods | 741 | 258 |
Total inventory | 23,722 | 18,180 |
Clinical Member] | ||
Inventory Valuation [Abstract] | ||
Raw materials | 9,967 | 9,363 |
Commercial [Member] | ||
Inventory Valuation [Abstract] | ||
Raw materials | $ 9,543 | $ 6,520 |
Significant Accounting Polic_10
Significant Accounting Policies, Basic and Diluted Net Income (Loss) per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Basic Net Income (Loss) per Share [Abstract] | |||||
Basic net income (loss) per share (in dollars per share) | $ (0.23) | $ (0.01) | $ (0.58) | $ 0.62 | |
Net income (loss) | $ (31,845) | $ (876) | $ (80,071) | $ 83,567 | |
Net income (loss) available to Ionis common shareholders | $ (31,858) | $ (933) | $ (80,170) | $ 86,628 | |
Weighted average shares outstanding (in shares) | 139,352 | 140,247 | 139,391 | 139,419 | |
Income available to Ionis common shareholders | $ 86,628 | ||||
Shares issuable related to our Employee Stock Purchase Plan (in shares) | 8 | ||||
Shares used in computing diluted net income per share (in shares) | 139,352 | 140,247 | 139,391 | 142,499 | |
Diluted net income (loss) per share (in dollars per share) | $ (0.23) | $ (0.01) | $ (0.58) | $ 0.61 | |
0.125 Percent Convertible Senior Notes [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Interest rate on convertible senior notes | 0.125% | 0.125% | 0.125% | ||
1 Percent Convertible Senior Notes [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Interest rate on convertible senior notes | 1.00% | 1.00% | 1.00% | 1.00% | 1.00% |
Stock Options [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Shares issuable related to stock-based compensation (in shares) | 2,327 | ||||
Restricted Stock Awards [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Shares issuable related to stock-based compensation (in shares) | 745 | ||||
Ionis [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Net income (loss) | $ 5,807 | $ 27,311 | $ (9,822) | $ 91,008 | |
Akcea [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Net income (loss) | $ (37,665) | $ (28,244) | $ (70,348) | $ (4,380) | |
Akcea [Member] | Common Stock [Member] | |||||
Basic Net Income (Loss) per Share [Abstract] | |||||
Weighted average shares owned in Akcea (in shares) | 77,095 | 70,221 | 77,095 | 69,406 | |
Basic net income (loss) per share (in dollars per share) | $ (0.49) | $ (0.40) | $ (0.91) | $ (0.06) | |
Net income (loss) | $ (37,665) | $ (28,244) | $ (70,348) | $ (4,380) |
Significant Accounting Polic_11
Significant Accounting Policies, Convertible Debt (Details) | Jun. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2019 |
0.125 Percent Convertible Senior Notes [Member] | |||
Convertible Debt [Abstract] | |||
Interest rate on convertible senior notes | 0.125% | 0.125% | |
1 Percent Convertible Senior Notes [Member] | |||
Convertible Debt [Abstract] | |||
Interest rate on convertible senior notes | 1.00% | 1.00% | 1.00% |
Significant Accounting Polic_12
Significant Accounting Policies, Segment Information (Details) | 6 Months Ended |
Jun. 30, 2020Segment | |
Segment Information [Abstract] | |
Number of operating segments | 2 |
Significant Accounting Polic_13
Significant Accounting Policies, Stock-Based Compensation Expense (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation expense | $ 48,442 | $ 41,933 | $ 89,233 | $ 87,437 |
Cost of Products Sold [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation expense | 350 | 137 | 587 | 255 |
Research, Development and Patent [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation expense | 26,016 | 23,756 | 51,573 | 48,191 |
Selling, General and Administrative [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation expense | 22,076 | 18,040 | $ 37,073 | $ 38,991 |
Employee Stock Options [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Risk-free interest rate | 1.60% | 2.40% | ||
Dividend yield | 0.00% | 0.00% | ||
Volatility | 58.90% | 60.30% | ||
Expected life | 4 years 8 months 12 days | 4 years 7 months 6 days | ||
Unrecognized Compensation Expense [Abstract] | ||||
Unrecognized compensation expense related to non-vested stock options | 137,800 | $ 137,800 | ||
Weighted average period for recognition | 1 year 3 months 18 days | |||
ESPP [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Risk-free interest rate | 1.10% | 2.50% | ||
Dividend yield | 0.00% | 0.00% | ||
Volatility | 47.20% | 45.50% | ||
Expected life | 6 months | 6 months | ||
RSUs [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Vesting period | 4 years | |||
Unrecognized Compensation Expense [Abstract] | ||||
Unrecognized compensation cost related to non-vested RSUs | 103,700 | $ 103,700 | ||
Weighted average period for recognition | 1 year 8 months 12 days | |||
RSUs [Member] | Employees [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Weighted-average grant date fair value (in dollars per share) | $ 64.31 | |||
Akcea [Member] | ||||
Stock-based Compensation Expense [Abstract] | ||||
Stock-based compensation expense | $ 16,100 | $ 14,400 | $ 23,400 | $ 32,900 |
Akcea [Member] | Employee Stock Options [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Risk-free interest rate | 1.30% | 2.50% | ||
Dividend yield | 0.00% | 0.00% | ||
Volatility | 74.50% | 76.30% | ||
Expected life | 6 years 1 month 6 days | 6 years 1 month 6 days | ||
Akcea [Member] | Board of Director Stock Options [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Risk-free interest rate | 0.80% | 1.90% | ||
Dividend yield | 0.00% | 0.00% | ||
Volatility | 75.30% | 74.30% | ||
Expected life | 5 years 8 months 12 days | 6 years 3 months 18 days | ||
Akcea [Member] | ESPP [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Risk-free interest rate | 1.00% | 2.50% | ||
Dividend yield | 0.00% | 0.00% | ||
Volatility | 71.90% | 64.10% | ||
Expected life | 6 months | 6 months | ||
Akcea [Member] | RSUs [Member] | Employees [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Weighted-average grant date fair value (in dollars per share) | $ 15.76 | |||
Akcea [Member] | RSUs [Member] | Minimum [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Vesting period | 6 months | |||
Akcea [Member] | RSUs [Member] | Maximum [Member] | ||||
Weighted-Average Assumptions [Abstract] | ||||
Vesting period | 4 years |
Significant Accounting Polic_14
Significant Accounting Policies Amendments to Equity Plan (Details) - shares shares in Millions | Jun. 30, 2020 | May 31, 2020 |
Significant Accounting Policies [Abstract] | ||
Common shares reserved for future issuance (in shares) | 2.8 | 2 |
Significant Accounting Polic_15
Significant Accounting Policies, Share Repurchase Program (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Mar. 31, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Sep. 30, 2019 | |
Significant Accounting Policies [Abstract] | |||||
Authorized amount of share repurchase program | $ 125,000 | ||||
Shares repurchased (in shares) | 1,500,000 | 535,000 | |||
Shares repurchased | $ 90,600 | $ 90,548 | $ 0 | $ 34,400 |
Investments, Contract Maturity
Investments, Contract Maturity of Available-for-Sale Securities (Details) | 6 Months Ended |
Jun. 30, 2020Company | |
Contract Maturity of Available-for-Sale Securities [Abstract] | |
One year or less | 69.00% |
After one year but within two years | 23.00% |
After two years but within three years | 8.00% |
Total | 100.00% |
Percentage of available-for-sale securities with a maturity of less than two years | 92.00% |
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% | 5 |
Number of publicly-held companies in which there is an equity ownership interest of less than 20% | 2 |
Investments, Summary of Investm
Investments, Summary of Investments (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Dec. 31, 2019 | |||
Summary of Investments [Abstract] | ||||
Cost | $ 1,920,447 | $ 1,846,074 | ||
Gross unrealized gains | 25,562 | 5,007 | ||
Gross unrealized losses | (2,514) | (1,166) | ||
Estimated fair value | 1,943,495 | 1,849,915 | ||
Available-for-sale Securities [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1] | 1,900,716 | 1,831,362 | |
Gross unrealized gains | 16,244 | 5,007 | ||
Gross unrealized losses | (192) | (296) | ||
Estimated fair value | 1,916,768 | 1,836,073 | ||
Available-for-sale Securities [Member] | Securities with Maturity of One Year or Less [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1] | 1,187,843 | 1,206,616 | |
Gross unrealized gains | 5,984 | 2,012 | ||
Gross unrealized losses | (36) | (118) | ||
Estimated fair value | 1,193,791 | 1,208,510 | ||
Available-for-sale Securities [Member] | Securities with Maturity of More than One Year [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1] | 712,873 | 624,746 | |
Gross unrealized gains | 10,260 | 2,995 | ||
Gross unrealized losses | (156) | (178) | ||
Estimated fair value | 722,977 | 627,563 | ||
Corporate Debt Securities [Member] | Securities with Maturity of One Year or Less [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1],[2] | 652,555 | 669,665 | |
Gross unrealized gains | 4,275 | 1,451 | ||
Gross unrealized losses | (17) | (43) | ||
Estimated fair value | 656,813 | 671,073 | ||
Corporate Debt Securities [Member] | Securities with Maturity of More than One Year [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1] | 485,487 | 428,627 | |
Gross unrealized gains | 8,780 | 2,911 | ||
Gross unrealized losses | (121) | (43) | ||
Estimated fair value | 494,146 | 431,495 | ||
Debt Securities issued by U.S. Government Agencies [Member] | Securities with Maturity of One Year or Less [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1] | 139,810 | 188,216 | [2] |
Gross unrealized gains | 673 | 303 | ||
Gross unrealized losses | (9) | (43) | ||
Estimated fair value | 140,474 | 188,476 | ||
Debt Securities issued by U.S. Government Agencies [Member] | Securities with Maturity of More than One Year [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1] | 118,538 | 140,988 | |
Gross unrealized gains | 521 | 57 | ||
Gross unrealized losses | (28) | (117) | ||
Estimated fair value | 119,031 | 140,928 | ||
Debt Securities issued by the U.S. Treasury [Member] | Securities with Maturity of One Year or Less [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1],[2] | 325,925 | 327,670 | |
Gross unrealized gains | 815 | 232 | ||
Gross unrealized losses | (7) | (27) | ||
Estimated fair value | 326,733 | 327,875 | ||
Debt Securities issued by the U.S. Treasury [Member] | Securities with Maturity of More than One Year [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1] | 58,334 | 35,822 | |
Gross unrealized gains | 588 | 9 | ||
Gross unrealized losses | (4) | (12) | ||
Estimated fair value | 58,918 | 35,819 | ||
Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | Securities with Maturity of One Year or Less [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1] | 68,651 | 21,065 | [2] |
Gross unrealized gains | 214 | 26 | ||
Gross unrealized losses | (3) | (5) | ||
Estimated fair value | 68,862 | 21,086 | ||
Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | Securities with Maturity of More than One Year [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1] | 50,514 | 19,309 | |
Gross unrealized gains | 371 | 18 | ||
Gross unrealized losses | (3) | (6) | ||
Estimated fair value | 50,882 | 19,321 | ||
Other Municipal Debt Securities [Member] | Securities with Maturity of One Year or Less [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [1] | 902 | ||
Gross unrealized gains | 7 | |||
Gross unrealized losses | 0 | |||
Estimated fair value | 909 | |||
Equity Securities [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | 19,731 | 14,712 | ||
Gross unrealized gains | 9,318 | 0 | ||
Gross unrealized losses | (2,322) | (870) | ||
Estimated fair value | 26,727 | 13,842 | ||
Equity Securities in Public Company [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [3] | 4,712 | 4,712 | |
Gross unrealized gains | 0 | 0 | ||
Gross unrealized losses | (2,322) | (870) | ||
Estimated fair value | 2,390 | 3,842 | ||
Equity Securities in Private Companies [Member] | ||||
Summary of Investments [Abstract] | ||||
Cost | [4] | 15,019 | 10,000 | |
Gross unrealized gains | 9,318 | 0 | ||
Gross unrealized losses | 0 | 0 | ||
Estimated fair value | $ 24,337 | $ 10,000 | ||
[1] | We hold our available-for-sale securities at amortized cost. | |||
[2] | Includes investments classified as cash equivalents on our condensed consolidated balance sheet. | |||
[3] | Our equity securities included in other current assets consisted of our investments in publicly-traded companies. We recognize publicly-traded equity securities at fair value. | |||
[4] | Our equity securities included in deposits and other assets consisted of our investments in privately-held companies. We recognize our private company 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. |
Investments, Investments Tempor
Investments, Investments Temporarily Impaired (Details) $ in Thousands | Jun. 30, 2020USD ($)Investment |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 78 |
Estimated fair value, less than 12 months of temporary impairment | $ 249,679 |
Unrealized losses, less than 12 months of temporary impairment | (188) |
Estimated fair value, more than 12 months of temporary impairment | 26,997 |
Unrealized losses, more than 12 months of temporary impairment | (4) |
Estimated fair value, total temporary impairment | 276,676 |
Unrealized losses, total temporary impairment | $ (192) |
Corporate Debt Securities [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 37 |
Estimated fair value, less than 12 months of temporary impairment | $ 87,460 |
Unrealized losses, less than 12 months of temporary impairment | (138) |
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 | 87,460 |
Unrealized losses, total temporary impairment | $ (138) |
Debt Securities issued by U.S. Government Agencies [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 10 |
Estimated fair value, less than 12 months of temporary impairment | $ 44,389 |
Unrealized losses, less than 12 months of temporary impairment | (33) |
Estimated fair value, more than 12 months of temporary impairment | 26,997 |
Unrealized losses, more than 12 months of temporary impairment | (4) |
Estimated fair value, total temporary impairment | 71,386 |
Unrealized losses, total temporary impairment | $ (37) |
Debt Securities issued by the U.S. Treasury [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 9 |
Estimated fair value, less than 12 months of temporary impairment | $ 110,067 |
Unrealized losses, less than 12 months of temporary impairment | (11) |
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 | 110,067 |
Unrealized losses, total temporary impairment | $ (11) |
Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | |
Temporarily Impaired Investments [Abstract] | |
Number of investments | Investment | 22 |
Estimated fair value, less than 12 months of temporary impairment | $ 7,763 |
Unrealized losses, less than 12 months of temporary impairment | (6) |
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 | 7,763 |
Unrealized losses, total temporary impairment | $ (6) |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2019 | |||
1 Percent Convertible Senior Notes [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Interest rate on convertible senior notes | 1.00% | 1.00% | 1.00% | |||
0.125 Percent Convertible Senior Notes [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Interest rate on convertible senior notes | 0.125% | 0.125% | ||||
Significant Other Observable Inputs (Level 2) [Member] | 1 Percent Convertible Senior Notes [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Fair value of convertible notes | $ 340,500 | |||||
Significant Other Observable Inputs (Level 2) [Member] | 0.125 Percent Convertible Senior Notes [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Fair value of convertible notes | 536,500 | |||||
Recurring Basis [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Cash equivalents | [1] | 363,019 | $ 418,406 | |||
Investment in ProQR Therapeutics N.V. | [2] | 2,390 | 4,506 | |||
Total | 2,282,177 | 2,258,985 | ||||
Recurring Basis [Member] | Corporate Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 1,150,959 | [3] | 1,102,568 | [4] | ||
Recurring Basis [Member] | Corporate Debt Securities [Member] | Cash and Cash Equivalents [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 32,400 | 19,000 | ||||
Recurring Basis [Member] | Debt Securities issued by U.S. Government Agencies [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 259,505 | [5] | 329,404 | [6] | ||
Recurring Basis [Member] | Debt Securities issued by U.S. Government Agencies [Member] | Cash and Cash Equivalents [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 800 | |||||
Recurring Basis [Member] | Debt Securities issued by the U.S. Treasury [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 385,651 | [7] | 363,694 | [5] | ||
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 | 59,700 | |||||
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 | 119,744 | [8] | 40,407 | [5] | ||
Recurring Basis [Member] | Debt Securities issued by States of the U.S. and Political Subdivisions of the States [Member] | Cash and Cash Equivalents [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 6,200 | |||||
Recurring Basis [Member] | Other Municipal Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | [5] | 909 | ||||
Recurring Basis [Member] | Quoted Prices in Active Markets (Level 1) [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Cash equivalents | 363,019 | 418,406 | ||||
Investment in ProQR Therapeutics N.V. | 684 | 0 | ||||
Total | 749,354 | 782,100 | ||||
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 | 385,651 | 363,694 | ||||
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 | 1,531,117 | 1,472,379 | ||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Corporate Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 1,150,959 | [3] | 1,102,568 | |||
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 | 259,505 | 329,404 | ||||
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 | 119,744 | 40,407 | ||||
Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Other Municipal Debt Securities [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Available-for-sale securities | 909 | |||||
Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||||||
Fair Value Measurements [Abstract] | ||||||
Cash equivalents | 0 | 0 | ||||
Investment in ProQR Therapeutics N.V. | 1,706 | 4,506 | ||||
Total | 1,706 | 4,506 | ||||
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 | |||||
[1] | Included in cash and cash equivalents. | |||||
[2] | Included in other current assets. | |||||
[3] | $32.4 million was included in cash and cash equivalents, with the difference included in short-term investments. | |||||
[4] | $19.0 million was included in cash and cash equivalents, with the difference included in short-term investments. | |||||
[5] | Included in short-term investments. | |||||
[6] | $0.8 million was included in cash and cash equivalents, with the difference included in short-term investments. | |||||
[7] | $59.7 million was included in cash and cash equivalents, with the difference included in short-term investments. | |||||
[8] | $6.2 million was included in cash and cash equivalents, with the difference included in short-term investments. |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Taxes [Abstract] | |||||
Percentage of taxable income that can be offset with federal net operating losses | 100.00% | ||||
Tax benefit related to CARES Act | $ (1,700) | ||||
Income tax expense (benefit) | $ (439) | $ (6,927) | $ (3,696) | $ 24,119 | |
Effective tax rate | 3.50% | ||||
Federal statutory rate | 21.00% | ||||
Akcea [Member] | |||||
Income Taxes [Abstract] | |||||
Tax benefit related to CARES Act | $ (1,700) | $ (1,700) |
Collaborative Arrangements an_3
Collaborative Arrangements and Licensing Agreements, Biogen (Details) $ in Thousands | Aug. 05, 2020USD ($) | Jul. 31, 2020USD ($) | Jun. 30, 2020USD ($)Medicine | Mar. 31, 2020USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($)Medicine | Jun. 30, 2019USD ($) | Dec. 31, 2019USD ($) |
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Revenue | $ 145,537 | $ 163,813 | $ 278,905 | $ 461,026 | |||||
SPINRAZA Royalties [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Revenue | 71,746 | 70,502 | 137,754 | 130,212 | |||||
R&D Revenue [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Revenue | $ 55,803 | 75,514 | $ 105,209 | 304,640 | |||||
Biogen [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Number of medicines currently being developed | Medicine | 8 | 8 | |||||||
Cumulative payments received | $ 2,600,000 | $ 2,600,000 | |||||||
Revenue | 97,700 | $ 102,400 | 185,200 | $ 186,600 | |||||
Deferred revenue | $ 486,600 | $ 486,600 | $ 525,800 | ||||||
Biogen [Member] | Revenue [Member] | Strategic Partner [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Concentration percentage | 67.00% | 63.00% | 66.00% | 41.00% | |||||
Biogen [Member] | SPINRAZA Royalties [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Revenue | $ 71,700 | $ 70,500 | $ 137,800 | $ 130,200 | |||||
Biogen [Member] | R&D Revenue [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Revenue | 26,000 | $ 31,900 | 47,400 | $ 56,400 | |||||
2012 Neurology [Member] | IONIS-MAPT [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Milestone payment achieved | $ 7,500 | ||||||||
Payments included in transaction price for performance obligation | $ 7,500 | ||||||||
Cumulative payments included in transaction price for performance obligation | $ 45,000 | $ 45,000 | |||||||
2012 Neurology [Member] | IONIS-MAPT [Member] | Subsequent Event [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Milestone payment achieved | $ 12,000 | ||||||||
2012 Neurology [Member] | IONIS-MAPT [Member] | Maximum [Member] | Subsequent Event [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Next prospective payment | $ 25,000 | ||||||||
2013 Strategic Neurology [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Revenue | $ (16,500) | ||||||||
Number of medicines advanced to achieve next potential payment | Medicine | 1 | 1 | |||||||
2013 Strategic Neurology [Member] | Maximum [Member] | Subsequent Event [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Next prospective payment | $ 10,000 | ||||||||
2013 Strategic Neurology [Member] | ION464 [Member] | Subsequent Event [Member] | |||||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | |||||||||
Milestone payment achieved | $ 18,000 |
Collaborative Arrangements an_4
Collaborative Arrangements and Licensing Agreements, AstraZeneca (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2020USD ($)Agreement | Mar. 31, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($)Agreement | Jun. 30, 2019USD ($) | Dec. 31, 2019USD ($) | |
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 145,537 | $ 163,813 | $ 278,905 | $ 461,026 | ||
R&D Revenue [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 55,803 | $ 75,514 | $ 105,209 | $ 304,640 | ||
AstraZeneca [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Number of collaboration agreements | Agreement | 2 | 2 | ||||
Cumulative payments received | $ 300,000 | $ 300,000 | ||||
Deferred revenue | $ 17,500 | $ 17,500 | $ 25,000 | |||
AstraZeneca [Member] | Revenue [Member] | Strategic Partner [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Concentration percentage | 12.00% | 2.00% | 11.00% | 2.00% | ||
AstraZeneca [Member] | R&D Revenue [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 16,800 | $ 3,800 | $ 30,500 | $ 7,800 | ||
Cardiovascular, Renal and Metabolic Diseases [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Number of collaboration agreements | Agreement | 1 | 1 | ||||
Milestone payment achieved | $ 10,000 | |||||
Revenue | 10,000 | |||||
Cardiovascular, Renal and Metabolic Diseases [Member] | Maximum [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Next prospective payment | $ 30,000 | $ 30,000 | ||||
Cardiovascular, Renal and Metabolic Diseases [Member] | R&D Revenue [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 10,000 | |||||
Oncology [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Number of collaboration agreements | Agreement | 1 | 1 | ||||
Next prospective payment | $ 12,000 | $ 12,000 | ||||
Oncology [Member] | R&D Revenue [Member] | ||||||
Collaborative Arrangement and Licensing Agreement [Abstract] | ||||||
Revenue | $ 13,000 |
Collaborative Arrangements an_5
Collaborative Arrangements and Licensing Agreements, Janssen Biotech, Inc. (Details) - Janssen Biotech, Inc. [Member] - Subsequent Event [Member] $ in Millions | 1 Months Ended |
Jul. 31, 2020USD ($) | |
Collaborative Arrangement and Licensing Agreement [Abstract] | |
Milestone payment achieved | $ 5 |
Next prospective payment | $ 5 |
Segment Information (Details)
Segment Information (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($)Segment | Jun. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Jun. 30, 2017 | |
Segment Information [Abstract] | ||||||
Number of reportable segments | Segment | 2 | |||||
Segment Information [Abstract] | ||||||
Revenue | $ 145,537 | $ 163,813 | $ 278,905 | $ 461,026 | ||
Total operating expenses | 197,291 | 182,640 | 391,784 | 358,320 | ||
Income (loss) from operations | (51,754) | (18,827) | (112,879) | 102,706 | ||
Total assets | 3,078,950 | 3,078,950 | $ 3,233,112 | |||
Commercial Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 89,734 | 88,299 | 173,696 | 156,386 | ||
SPINRAZA Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 71,746 | 70,502 | 137,754 | 130,212 | ||
Product Sales, Net [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 16,364 | 9,865 | 31,523 | 16,619 | ||
Licensing and Other Royalty Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 1,624 | 7,932 | 4,419 | 9,555 | ||
R&D Revenue Under Collaborative Agreements [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | $ 55,803 | 75,514 | $ 105,209 | 304,640 | ||
Akcea [Member] | ||||||
Segment Information [Abstract] | ||||||
Percentage ownership | 76.00% | 76.00% | 100.00% | |||
Operating Segments [Member] | Ionis Core [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | $ 129,053 | 140,189 | $ 247,150 | 362,078 | ||
Total operating expenses | 131,177 | 121,774 | 266,602 | 236,290 | ||
Income (loss) from operations | (2,124) | 18,415 | (19,452) | 125,788 | ||
Total assets | 3,397,604 | 3,397,604 | 3,478,081 | |||
Operating Segments [Member] | Ionis Core [Member] | Commercial Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 73,983 | 75,398 | 143,589 | 136,731 | ||
Operating Segments [Member] | Ionis Core [Member] | SPINRAZA Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 71,746 | 70,502 | 137,754 | 130,212 | ||
Operating Segments [Member] | Ionis Core [Member] | Product Sales, Net [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | 0 | 0 | 0 | ||
Operating Segments [Member] | Ionis Core [Member] | Licensing and Other Royalty Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 2,237 | 4,896 | 5,835 | 6,519 | ||
Operating Segments [Member] | Ionis Core [Member] | R&D Revenue Under Collaborative Agreements [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 55,070 | 64,791 | 103,561 | 225,347 | ||
Operating Segments [Member] | Akcea Therapeutics [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 22,377 | 26,624 | 38,451 | 190,440 | ||
Total operating expenses | 73,468 | 65,328 | 134,800 | 202,938 | ||
Income (loss) from operations | (51,091) | (38,704) | (96,349) | (12,498) | ||
Total assets | 527,937 | 527,937 | 599,250 | |||
Operating Segments [Member] | Akcea Therapeutics [Member] | Commercial Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 16,364 | 15,901 | 31,523 | 22,655 | ||
Operating Segments [Member] | Akcea Therapeutics [Member] | SPINRAZA Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | 0 | 0 | 0 | ||
Operating Segments [Member] | Akcea Therapeutics [Member] | Product Sales, Net [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 16,364 | 9,865 | 31,523 | 16,619 | ||
Operating Segments [Member] | Akcea Therapeutics [Member] | Licensing and Other Royalty Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | 6,036 | 0 | 6,036 | ||
Operating Segments [Member] | Akcea Therapeutics [Member] | R&D Revenue Under Collaborative Agreements [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 6,013 | 10,723 | 6,928 | 167,785 | ||
Elimination of Intercompany Activity [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | (5,893) | (3,000) | (6,696) | (91,492) | ||
Total operating expenses | (7,354) | (4,462) | (9,618) | (80,908) | ||
Income (loss) from operations | 1,461 | 1,462 | 2,922 | (10,584) | ||
Total assets | (846,591) | (846,591) | $ (844,219) | |||
Elimination of Intercompany Activity [Member] | Commercial Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | (613) | (3,000) | (1,416) | (3,000) | ||
Elimination of Intercompany Activity [Member] | SPINRAZA Royalties [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | 0 | 0 | 0 | ||
Elimination of Intercompany Activity [Member] | Product Sales, Net [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | 0 | 0 | 0 | 0 | ||
Elimination of Intercompany Activity [Member] | Licensing and Other Royalty Revenue [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | (613) | (3,000) | (1,416) | (3,000) | ||
Elimination of Intercompany Activity [Member] | R&D Revenue Under Collaborative Agreements [Member] | ||||||
Segment Information [Abstract] | ||||||
Revenue | $ (5,280) | $ 0 | $ (5,280) | $ (88,492) |