Document And Entity Information
Document And Entity Information | 6 Months Ended |
Jun. 30, 2021shares | |
Document and Entity Information [Abstract] | |
Document Type | 10-Q |
Document Quarterly Report | true |
Document Transition Report | false |
Document Period End Date | Jun. 30, 2021 |
Entity File Number | 001-35668 |
Entity Registrant Name | INTERCEPT PHARMACEUTICALS, INC. |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 22-3868459 |
Entity Address, Address Line One | 10 Hudson Yards, 37th Floor |
Entity Address, City or Town | New York |
Entity Address, State or Province | NY |
Entity Address, Postal Zip Code | 10001 |
City Area Code | 646 |
Local Phone Number | 747-1000 |
Title of 12(b) Security | Common Stock |
Trading Symbol | ICPT |
Security Exchange Name | NASDAQ |
Entity Current Reporting Status | Yes |
Entity Interactive Data Current | Yes |
Entity Filer Category | Large Accelerated Filer |
Entity Small Business | false |
Entity Emerging Growth Company | false |
Entity Shell Company | false |
Entity Common Stock, Shares Outstanding | 33,201,181 |
Entity Central Index Key | 0001270073 |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Period Focus | Q2 |
Document Fiscal Year Focus | 2021 |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 145,620 | $ 58,151 |
Restricted cash | 8,057 | 7,503 |
Investment debt securities, available-for-sale | 268,803 | 411,516 |
Accounts receivable, net of allowance for credit losses of $279 and $235, respectively | 45,250 | 41,549 |
Prepaid expenses and other current assets | 25,375 | 27,022 |
Total current assets | 493,105 | 545,741 |
Fixed assets, net | 4,610 | 6,326 |
Inventory | 9,004 | 9,027 |
Security deposits | 6,683 | 7,068 |
Other assets | 9,822 | 12,327 |
Total assets | 523,224 | 580,489 |
Current liabilities: | ||
Accounts payable, accrued expenses and other liabilities | 137,244 | 171,039 |
Short-term interest payable | 8,037 | 8,037 |
Total current liabilities | 145,281 | 179,076 |
Long-term liabilities: | ||
Long-term debt | 575,815 | 560,582 |
Long-term other liabilities | 5,323 | 7,684 |
Total liabilities | 726,419 | 747,342 |
Commitments and contingencies (Note 16) | ||
Stockholders' deficit: | ||
Common stock par value $0.001 per share; 90,000,000 shares authorized; 33,201,181 and 33,015,614 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 33 | 33 |
Additional paid-in capital | 2,249,497 | 2,233,937 |
Accumulated other comprehensive loss, net | (2,865) | (2,477) |
Accumulated deficit | (2,449,860) | (2,398,346) |
Total stockholders' deficit | (203,195) | (166,853) |
Total liabilities and stockholders' deficit | $ 523,224 | $ 580,489 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Condensed Consolidated Balance Sheets | ||
Allowance for credit losses | $ 279 | $ 235 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized | 90,000,000 | 90,000,000 |
Common stock, shares, issued | 33,201,181 | 33,015,614 |
Common stock, shares, outstanding | 33,201,181 | 33,015,614 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue | $ 96,576 | $ 77,249 | $ 178,237 | $ 149,901 |
Operating expenses: | ||||
Cost of sales | 618 | 1,877 | 1,428 | 2,729 |
Selling, general and administrative | 57,655 | 93,360 | 116,926 | 191,918 |
Research and development | 37,792 | 34,042 | 88,558 | 90,729 |
Restructuring | (249) | 0 | (88) | 0 |
Total operating expenses | 95,816 | 129,279 | 206,824 | 285,376 |
Operating income (loss) | 760 | (52,030) | (28,587) | (135,475) |
Other income (expense): | ||||
Interest expense | (12,589) | (11,933) | (25,008) | (23,710) |
Other income, net | 735 | 682 | 2,081 | 2,921 |
Total other (expense), net | (11,854) | (11,251) | (22,927) | (20,789) |
Net loss | $ (11,094) | $ (63,281) | $ (51,514) | $ (156,264) |
Net loss per common and potential common share: | ||||
Basic and diluted | $ (0.33) | $ (1.92) | $ (1.55) | $ (4.74) |
Weighted average common and potential common shares outstanding: | ||||
Basic and diluted | 33,179 | 32,960 | 33,159 | 32,941 |
Product [Member] | ||||
Revenue | $ 96,576 | $ 77,249 | $ 178,237 | $ 149,901 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (11,094) | $ (63,281) | $ (51,514) | $ (156,264) |
Net changes related to available-for-sale investment debt securities: | ||||
Unrealized (losses) gains on investment debt securities | (23) | 3,123 | (367) | 960 |
Reclassification adjustment for realized gains on investment debt securities included in other income, net | 0 | 44 | 2 | 53 |
Net unrealized (losses) gains on investment debt securities | (23) | 3,167 | (365) | 1,013 |
Foreign currency translation losses | (304) | (488) | (23) | (1,000) |
Other comprehensive (loss) income | (327) | 2,679 | (388) | 13 |
Comprehensive loss | $ (11,421) | $ (60,602) | $ (51,902) | $ (156,251) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' (Deficit) Equity - USD ($) shares in Thousands, $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated (Deficit) Equity [Member] | Total |
Balance at Dec. 31, 2019 | $ 33 | $ 2,176,133 | $ (1,144) | $ (2,123,466) | $ 51,556 |
Balance (in shares) at Dec. 31, 2019 | 32,853 | ||||
Stock-based compensation | $ 0 | 28,556 | 0 | 0 | 28,556 |
Net proceeds from exercise of stock options | $ 0 | (1,052) | 0 | 0 | (1,052) |
Net proceeds from exercise of stock options (in shares) | 135 | ||||
Employee withholding taxes related to stock-based awards | $ 0 | (1,611) | 0 | 0 | (1,611) |
Employee withholding taxes related to stock-based awards, (in shares) | (7) | ||||
Other comprehensive income (loss) | $ 0 | 0 | 19 | 0 | 19 |
Net loss | 0 | 0 | 0 | (156,264) | (156,264) |
Balance at Jun. 30, 2020 | $ 33 | 2,202,026 | (1,125) | (2,279,730) | (78,796) |
Balance (in shares) at Jun. 30, 2020 | 32,981 | ||||
Balance at Mar. 31, 2020 | $ 33 | 2,185,501 | (3,804) | (2,216,449) | (34,719) |
Balance (in shares) at Mar. 31, 2020 | 32,937 | ||||
Stock-based compensation | $ 0 | 16,083 | 0 | 0 | 16,083 |
Net proceeds from exercise of stock options | $ 0 | 731 | 0 | 0 | 731 |
Net proceeds from exercise of stock options (in shares) | 47 | ||||
Employee withholding taxes related to stock-based awards | $ 0 | (289) | 0 | 0 | (289) |
Employee withholding taxes related to stock-based awards, (in shares) | (3) | ||||
Other comprehensive income (loss) | $ 0 | 0 | 2,679 | 0 | 2,679 |
Net loss | 0 | 0 | 0 | (63,281) | (63,281) |
Balance at Jun. 30, 2020 | $ 33 | 2,202,026 | (1,125) | (2,279,730) | (78,796) |
Balance (in shares) at Jun. 30, 2020 | 32,981 | ||||
Balance at Dec. 31, 2020 | $ 33 | 2,233,937 | (2,477) | (2,398,346) | (166,853) |
Balance (in shares) at Dec. 31, 2020 | 33,016 | ||||
Stock-based compensation | $ 0 | 16,867 | 0 | 0 | 16,867 |
Net proceeds from exercise of stock options | $ 0 | 18 | 0 | 0 | $ 18 |
Net proceeds from exercise of stock options (in shares) | 188 | 2 | |||
Employee withholding taxes related to stock-based awards | $ 0 | (1,325) | 0 | 0 | $ (1,325) |
Employee withholding taxes related to stock-based awards, (in shares) | (3) | ||||
Other comprehensive income (loss) | $ 0 | 0 | (388) | 0 | (388) |
Net loss | 0 | 0 | 0 | (51,514) | (51,514) |
Balance at Jun. 30, 2021 | $ 33 | 2,249,497 | (2,865) | (2,449,860) | (203,195) |
Balance (in shares) at Jun. 30, 2021 | 33,201 | ||||
Balance at Mar. 31, 2021 | $ 33 | 2,241,273 | (2,538) | (2,438,766) | (199,998) |
Balance (in shares) at Mar. 31, 2021 | 33,154 | ||||
Stock-based compensation | $ 0 | 8,448 | 0 | 0 | 8,448 |
Net proceeds from exercise of stock options | $ 0 | 18 | 0 | 0 | 18 |
Net proceeds from exercise of stock options (in shares) | 47 | ||||
Employee withholding taxes related to stock-based awards | $ 0 | (242) | 0 | 0 | (242) |
Employee withholding taxes related to stock-based awards, (in shares) | 0 | ||||
Other comprehensive income (loss) | $ 0 | 0 | (327) | 0 | (327) |
Net loss | 0 | 0 | 0 | (11,094) | (11,094) |
Balance at Jun. 30, 2021 | $ 33 | $ 2,249,497 | $ (2,865) | $ (2,449,860) | $ (203,195) |
Balance (in shares) at Jun. 30, 2021 | 33,201 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (51,514) | $ (156,264) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 16,867 | 28,556 |
Amortization of premium on investment debt securities | 2,296 | 1,344 |
Amortization of deferred financing costs | 1,356 | 1,242 |
Depreciation | 1,749 | 1,572 |
Non-cash operating lease cost | 2,921 | 3,175 |
Accretion of debt discount | 13,877 | 12,693 |
Provision for allowance of credit losses, net of write-offs | 44 | 208 |
Changes in operating assets: | ||
Accounts receivable | (4,027) | (2,212) |
Prepaid expenses and other current assets | 1,590 | (2,984) |
Inventory | 92 | (750) |
Security deposits | 345 | (247) |
Changes in operating liabilities: | ||
Accounts payable, accrued expenses and other current liabilities | (31,835) | 3,686 |
Operating lease liabilities | (3,892) | (3,592) |
Net cash used in operating activities | (50,131) | (113,573) |
Cash flows from investing activities: | ||
Purchases of investment debt securities | (87,407) | (187,188) |
Sales and maturities of investment debt securities | 227,459 | 285,727 |
Purchases of equipment, leasehold improvements, and furniture and fixtures | (397) | (658) |
Net cash provided by investing activities | 139,655 | 97,881 |
Cash flows from financing activities: | ||
Proceeds from exercise of options, net | 18 | 1,300 |
Payments of employee withholding taxes related to stock-based awards | (1,325) | (1,611) |
Net cash used in financing activities | (1,307) | (311) |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (194) | (1,840) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 88,023 | (17,843) |
Cash, cash equivalents and restricted cash at beginning of period | 65,654 | 74,780 |
Cash, cash equivalents and restricted cash at end of period | $ 153,677 | $ 56,937 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Supplemental disclosure of non-cash transactions: | ||||
Right-of-use asset obtained in exchange for new operating lease obligations | $ 0 | $ 1,006 | ||
Reconciliation of cash, cash equivalents and restricted cash included in the condensed consolidated balance sheets: | ||||
Cash and cash equivalents | 145,620 | 50,778 | $ 58,151 | |
Restricted cash | 8,057 | 6,159 | 7,503 | |
Total cash, cash equivalents and restricted cash | $ 153,677 | $ 56,937 | $ 65,654 | $ 74,780 |
Overview of Business
Overview of Business | 6 Months Ended |
Jun. 30, 2021 | |
Basis of Presentation [Abstract] | |
Overview of Business | 1. Overview of Business Intercept Pharmaceuticals, Inc. (the “Company”) is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (“PBC”) and nonalcoholic steatohepatitis (“NASH”). The Company currently has one marketed product, Ocaliva (obeticholic acid or “OCA”). Founded in 2002 in New York, the Company has operations in the United States, Europe and Canada. |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2021 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions have been eliminated in consolidation. Certain information that is normally required by U.S. GAAP has been condensed or omitted in accordance with rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Operating results for the three and six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2021. In the opinion of management, these unaudited condensed consolidated financial statements include all normal and recurring adjustments considered necessary for a fair presentation of these interim unaudited condensed consolidated financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2020, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC. Use of Estimates The preparation of these unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from these estimates. We are not presently aware of any events or circumstances arising from the coronavirus (“COVID-19”) pandemic that would require us to update our estimates or judgments or revise the carrying value of our assets or liabilities. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Significant Accounting Policiies | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company adopted ASU 2019-12 on January 1, 2021 and its adoption did not have any material impact on the Company’s condensed consolidated financial statements and related disclosures. Recent Accounting Pronouncements to be Adopted In August 2020, the FASB issued ASU No. 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required under current U.S. GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. Either a modified retrospective method of transition or a fully retrospective method of transition is permissible for the adoption of this standard. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2021, with early adoption permitted. The Company expects the impact of this standard to be material on its consolidated financial statements and related disclosures . |
Cash, Cash Equivalents and Inve
Cash, Cash Equivalents and Investment Debt Securities | 6 Months Ended |
Jun. 30, 2021 | |
Cash, Cash Equivalents, and Investment Debt Securities [Abstract] | |
Cash, Cash Equivalents, and Investment Debt Securities | 4. Cash, Cash Equivalents and Investment Debt Securities The following table summarizes the Company’s cash, cash equivalents and investment debt securities as of June 30, 2021 and December 31, 2020: As of June 30, 2021 Allowance Gross Gross for Credit Unrealized Unrealized Amortized Cost Losses Gains Losses Fair Value (in thousands) Cash and cash equivalents: Cash and money market funds $ 145,620 $ — $ — $ — $ 145,620 Total cash and cash equivalents 145,620 — — — 145,620 Investment debt securities: Commercial paper 53,334 — 2 (2) 53,334 Corporate debt securities 215,375 — 125 (31) 215,469 Total investment debt securities 268,709 — 127 (33) 268,803 Total cash, cash equivalents and investment debt securities $ 414,329 $ — $ 127 $ (33) $ 414,423 As of December 31, 2020 Allowance Gross Gross for Credit Unrealized Unrealized Amortized Cost Losses Gains Losses Fair Value (in thousands) Cash and cash equivalents: Cash and money market funds $ 58,151 $ — $ — $ — $ 58,151 Total cash and cash equivalents 58,151 — — — 58,151 Investment debt securities: Commercial paper 55,460 — 6 (9) 55,457 Corporate debt securities 355,597 — 529 (67) 356,059 Total investment debt securities 411,057 — 535 (76) 411,516 Total cash, cash equivalents and investment debt securities $ 469,208 $ — $ 535 $ (76) $ 469,667 The aggregate fair value of the Company’s available-for-sale investment debt securities that have been in a continuous unrealized loss position for less than twelve months or twelve months or longer is as follows: As of June 30, 2021 Less than 12 months 12 months or longer Total (in thousands) Gross Gross Gross Unrealized Unrealized Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Commercial paper $ 17,338 $ (2) $ — $ — $ 17,338 $ (2) Corporate debt securities 119,980 (31) — — 119,980 (31) Total $ 137,318 $ (33) $ — $ — $ 137,318 $ (33) As of December 31, 2020 Less than 12 months 12 months or longer Total (in thousands) Gross Gross Gross Unrealized Unrealized Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Commercial paper $ 32,970 $ (9) $ — $ — $ 32,970 $ (9) Corporate debt securities 143,076 (67) — — 143,076 (67) Total $ 176,046 $ (76) $ — $ — $ 176,046 $ (76) |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Measurements [Abstract] | |
Fair Value Measurements | 5. Fair Value Measurements The carrying amounts of the Company’s receivables and payables approximate their fair value due to their short maturities. Accounting principles provide guidance for using fair value to measure assets and liabilities. The guidance includes a three-level hierarchy of valuation techniques used to measure fair value, defined as follows: ● Unadjusted Quoted Prices — The fair value of an asset or liability is based on unadjusted quoted prices in active markets for identical assets or liabilities (Level 1). ● Pricing Models with Significant Observable Inputs — The fair value of an asset or liability is based on information derived from either an active market quoted price, which may require further adjustment based on the attributes of the financial asset or liability being measured, or an inactive market transaction (Level 2). ● Pricing Models with Significant Unobservable Inputs — The fair value of an asset or liability is primarily based on internally derived assumptions surrounding the timing and amount of expected cash flows for the financial instrument. Therefore, these assumptions are unobservable in either an active or inactive market (Level 3). The Company considers an active market as one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Conversely, the Company views an inactive market as one in which there are few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers. Where appropriate, non-performance risk, or that of a counterparty, is considered in determining the fair values of liabilities and assets, respectively. The Company’s money market funds are classified within Level 1 of the fair value hierarchy because they are valued using quoted prices in active markets. Investment debt securities are classified as Level 2 instruments based on market pricing and other observable inputs. Financial assets carried at fair value are classified in the tables below in one of the three categories described above: Fair Value Measurements Using Total Level 1 Level 2 Level 3 (in thousands) June 30, 2021 Assets Cash and cash equivalents: Money market funds $ 81,733 $ 81,733 $ — $ — Available-for-sale investment debt securities: Commercial paper 53,334 — 53,334 — Corporate debt securities 215,469 — 215,469 — Total financial assets $ 350,536 $ 81,733 $ 268,803 $ — December 31, 2020 Assets Cash and cash equivalents: Money market funds $ 15,492 $ 15,492 $ — $ — Available-for-sale investment debt securities: Commercial paper 55,457 — 55,457 — Corporate debt securities 356,059 — 356,059 — Total financial assets $ 427,008 $ 15,492 $ 411,516 $ — See Note 10 for the carrying amount and estimated fair value of our and The aggregate fair value of all available-for-sale investment debt securities (commercial paper and corporate debt securities), by contractual maturity, are as follows: Fair Value as of June 30, 2021 December 31, 2020 (in thousands) Due in one year or less $ 252,425 $ 328,077 Due after one year through two years 16,378 83,439 Total investment debt securities $ 268,803 $ 411,516 Actual maturities may differ from contractual maturities because issuers may have the right to call or prepay obligations without call or prepayment penalties. |
Fixed Assets, Net
Fixed Assets, Net | 6 Months Ended |
Jun. 30, 2021 | |
Fixed Assets, Net [Abstract] | |
Fixed Assets, Net | 6. Fixed Assets, Net Fixed assets are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows: Useful lives (Years) June 30, 2021 December 31, 2020 (in thousands) Office equipment and software 3 $ 5,390 $ 5,364 Leasehold improvements Shorter of remaining lease term or useful life 13,250 13,237 Furniture and fixtures 7 4,610 4,602 Subtotal 23,250 23,203 Less: accumulated depreciation (18,640) (16,877) Fixed assets, net $ 4,610 $ 6,326 |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2021 | |
Inventory [Abstract] | |
Inventory | 7. Inventory Inventories are stated at the lower of cost or market. Inventories consisted of the following: June 30, 2021 December 31, 2020 (in thousands) Work-in-process $ 8,400 $ 8,394 Finished goods 604 633 Inventory $ 9,004 $ 9,027 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Leases | 8. Leases The Company leases various office spaces under non-cancelable operating leases with original lease periods expiring between the first quarter of 2022 and 2025. The Company also enters into leases for equipment. A number of the Company’s leases include one or more options to renew, with renewal terms that can extend Operating lease assets and liabilities are classified on the condensed consolidated balance sheets as follows: Leases Classification June 30, 2021 December 31, 2020 Assets (in thousands) Operating lease assets Other assets $ 9,822 $ 12,327 Total leased assets $ 9,822 $ 12,327 Liabilities Current Operating lease liabilities Accounts payable, accrued expenses and other liabilities $ 6,127 $ 7,248 Noncurrent Operating lease liabilities Long-term other liabilities 5,323 7,684 Total operating lease liabilities $ 11,450 $ 14,932 Operating lease costs for the three and six-month periods ended June 30, 2021 and 2020, are as follows: Three Months Ended June 30, Six Months Ended June 30, Lease Cost Classification 2021 2020 2021 2020 (in thousands) (in thousands) Operating lease cost Selling, general and administrative expenses $ 1,569 $ 1,730 $ 3,254 $ 3,469 Short-term lease cost Selling, general and administrative expenses 515 1,542 1,154 1,963 Variable lease cost Selling, general and administrative expenses 211 364 592 611 Sublease expense (income) Other income, net — 6 — (114) Net lease cost $ 2,295 $ 3,642 $ 5,000 $ 5,929 The weighted-average remaining term of the Company’s operating leases was 2.6 years and the weighted-average discount rate used to measure the present value of the Company’s operating lease liabilities was 5.2% as of June 30, 2021. Cash payments included in the measurement of the Company’s operating lease liabilities reported in operating cash flows were $4.2 million and $3.8 million for the six months ended June 30, 2021 and 2020, respectively. During the six months ended June 30, 2020, the Company obtained a ROU asset of $1.0 million in exchange for new operating lease obligations of $1.0 million. Maturities of the Company’s operating lease liabilities, which do not include short-term leases, as of June 30, 2021 are as follows: Maturity of Lease Liabilities Operating leases (in thousands) 2021 (remaining) $ 4,045 2022 3,615 2023 2,150 2024 1,616 2025 1,033 Thereafter — Total lease payments 12,459 Less: Present value discount (1,009) Total operating lease liabilities $ 11,450 |
Accounts Payable, Accrued Expen
Accounts Payable, Accrued Expenses and Other Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Accounts Payable, Accrued Expenses and Other Liabilities [Abstract] | |
Accounts Payable, Accrued Expenses and Other Liabilities | 9. Accounts Payable, Accrued Expenses and Other Liabilities Accounts payable, accrued expenses and other liabilities consisted of the following: June 30, 2021 December 31, 2020 (in thousands) Accounts payable $ 15,092 $ 24,594 Accrued employee compensation 20,407 27,154 Accrued contracted services 46,026 62,425 Accrued restructuring — 2,504 Accrued rebates, discounts and other incentives 41,247 38,172 Operating lease liabilities 6,127 7,248 Other liabilities 8,345 8,942 Accounts payable, accrued expenses and other liabilities $ 137,244 $ 171,039 The Company has $32.1 million and $27.4 million in rebates as of June 30, 2021 and December 31, 2020, respectively, included in Accrued rebates, discounts and other incentives, for a European jurisdiction in which final pricing is subject to ongoing negotiations with the government. Research & Development Tax Credit The Company has benefited from the U.K. Small and Medium-sized Enterprise R&D Tax Credit scheme, or the SME scheme, under which it can obtain a tax credit of up to 33.4% of eligible research and development expenses incurred by the Company in the U.K. Eligible expenses generally include employment costs for research staff, consumables, software and certain internal overhead costs incurred as part of research projects. The Company has also started to recently benefit from the U.K. Research and Development Expenditure Scheme, or the RDEC scheme, under which it can obtain a tax credit of 12% of eligible research and development expenses incurred by the Company in the U.K. The RDEC scheme is more restrictive than the SME scheme, and generally applies where qualifying R&D expenditure is not eligible for relief under the SME scheme. The Company has submitted claims seeking to obtain tax credits for qualifying R&D expenses incurred in the 2015, 2016, 2017, and 2018 calendar years. As described further in Note 12, the 2017 SME claim was finalized during the quarter ended June 30, 2021, and therefore the $9.4 million payment received in June 2020, which was previously deferred, was released into income as a reduction to research & development expenses. With respect to the 2018 RDEC claim, in June 2021, the Company received a payment of $4.2 million from Her Majesty’s Revenue and Customs (“HMRC”), the U.K.’s government tax authority. Given the claim review has not been finalized for the 2018 year, the $4.2 million credit received is recorded as a deferred liability within Accounts payable, accrued expenses, and other liabilities. |
Long-Term Debt
Long-Term Debt | 6 Months Ended |
Jun. 30, 2021 | |
Long-Term Debt [Abstract] | |
Long-Term Debt | 10. Long-Term Debt Debt, net of discounts and deferred financing costs, consisted of the following: June 30, 2021 December 31, 2020 (in thousands) 2023 Convertible Notes $ 460,000 $ 460,000 2026 Convertible Notes 230,000 230,000 Long-term debt, gross 690,000 690,000 Less: Unamortized debt discounts and fees (114,185) (129,418) Long-term debt, net $ 575,815 $ 560,582 2019 Offering On May 14, 2019, the Company issued and sold $230.0 million aggregate principal amount of 2.00% Convertible Senior Notes due 2026 (the “2026 Convertible Notes”). The Company received net proceeds from the sale of the 2026 Convertible Notes of $223.4 million, after deducting underwriting discounts, commissions and estimated offering expenses of approximately $6.6 million. The 2026 Convertible Notes were issued pursuant to a Second Supplemental Indenture, dated as of May 14, 2019 (the “Second Supplemental Indenture”), which supplements the Indenture (the “Base Indenture”), as supplemented by a First Supplemental Indenture (the “First Supplemental Indenture” and collectively with the Base Indenture and the Second Supplemental Indenture, the “Indenture”), each dated as of July 6, 2016, by and between the Company and U.S. Bank National Association, as trustee. The 2026 Convertible Notes are senior unsecured obligations of the Company, bear interest at a fixed rate of 2.00% per annum (payable semi-annually on May 15 and November 15 of each year, beginning on November 15, 2019) and will mature on May 15, 2026, unless earlier repurchased, redeemed or converted. Holders may convert their 2026 Convertible Notes at their option at any time prior to the close of business on the business day immediately preceding February 15, 2026 only under the following circumstances: (i) during any calendar quarter (and only during such calendar quarter) commencing after the calendar quarter ended on June 30, 2019, if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (ii) during the five business day period after any five consecutive trading day period in which the trading price (as defined in the Indenture) per $1,000 principal amount of 2026 Convertible Notes for each trading day of such five consecutive trading day period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; (iii) if the Company calls any or all of the 2026 Convertible Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; or (iv) upon the occurrence of specified corporate events. On or after February 15, 2026 until the close of business on the business day immediately preceding the maturity date, holders may convert their 2026 Convertible Notes at any time, regardless of the foregoing circumstances. Upon conversion of the 2026 Convertible Notes, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock (and cash in lieu of any fractional shares) or a combination of cash and shares of the Company’s common stock, at the Company’s election. The initial conversion rate of the 2026 Convertible Notes is 9.2123 shares of the Company’s common stock per $1,000 principal amount of 2026 Convertible Notes, which is equivalent to an initial conversion price of approximately $108.55 per share of the Company’s common stock. The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date, the Company will increase the conversion rate for a holder who elects to convert its 2026 Convertible Notes in connection with such a corporate event in certain circumstances. The Company may not redeem the 2026 Convertible Notes prior to May 20, 2023. The Company may redeem for cash all or any portion of the 2026 Convertible Notes, at the Company’s option, on or after May 20, 2023, if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the 2026 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the 2026 Convertible Notes. If the Company undergoes a fundamental change (as defined in the Indenture), holders may require the Company to repurchase for cash all or any portion of their 2026 Convertible Notes at a fundamental change repurchase price equal to 100% of the principal amount of the 2026 Convertible Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. The Indenture provides for customary events of default. In accordance with Accounting Standards Codification (“ASC”) Subtopic 470-20, “Debt with Conversion and Other Options” (“ASC 470-20”), the Company used an effective interest rate of 9.9% to determine the liability component of the 2026 Convertible Notes. This resulted in the recognition of $137.5 million as the liability component of the 2026 Convertible Notes and the recognition of the residual $85.9 million as the debt discount with a corresponding increase to additional paid-in capital for the equity component of the 2026 Convertible Notes. The underwriting discount and estimated offering expenses totaling $6.6 million were allocated between the debt and equity issuance costs in proportion to the allocation of the liability and equity components of the 2026 Convertible Notes. Accordingly, equity issuance costs of $2.5 million were recorded as an offset to additional paid-in capital and total debt issuance costs of $4.1 million were recorded on the issuance date and are reflected in the unaudited condensed consolidated balance sheet as a direct deduction from the carrying value of the associated debt liability. The debt discount and debt issuance costs will be amortized as non-cash interest expense through May 15, 2026. The fair value of the 2026 Convertible Notes was approximately $158.1 million and $142.8 million at June 30, 2021 and December 31, 2020, respectively, and was determined using Level 2 inputs based on quoted market values. 2016 Offerings On July 6, 2016, the Company issued and sold $460.0 million aggregate principal amount of 3.25% Convertible Senior Notes due 2023 (the “2023 Convertible Notes”, and together with the 2026 Convertible Notes, the “Convertible Notes”). The Company received net proceeds from the sale of the 2023 Convertible Notes of $447.6 million, after deducting underwriting discounts, commissions and estimated offering expenses of approximately $12.4 million. The Company used approximately $38.4 million of such net proceeds to fund the cost of the Capped Call Transactions (as defined below) that were entered into in connection with the issuance of the 2023 Convertible Notes. The 2023 Convertible Notes were issued pursuant to the Base Indenture, as supplemented by the First Supplemental Indenture. The 2023 Convertible Notes are senior unsecured obligations of the Company, bear interest at a fixed rate of 3.25% per year (payable semi-annually on January 1 and July 1 of each year, beginning on January 1, 2017) and will mature on July 1, 2023, unless earlier repurchased, redeemed or converted. Holders may convert their 2023 Convertible Notes at their option at any time prior to the close of business on the business day immediately preceding January 1, 2023 only under the following circumstances: (i) during any calendar quarter commencing after the calendar quarter ended on September 30, 2016, if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (ii) during the five business day period after any five consecutive trading day period in which the trading price (as defined in the Indenture) per $1,000 principal amount of 2023 Convertible Notes for each trading day of such five consecutive trading day period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; (iii) if the Company calls any or all of the 2023 Convertible Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; or (iv) upon the occurrence of specified corporate events. On or after January 1, 2023 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert their 2023 Convertible Notes at any time, regardless of the foregoing circumstances. Upon conversion of the 2023 Convertible Notes, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock (and cash in lieu of any fractional shares) or a combination of cash and shares of the Company’s common stock, at the Company’s election. The initial conversion rate of the 2023 Convertible Notes is 5.0358 shares of the Company’s common stock per $1,000 principal amount of 2023 Convertible Notes, which is equivalent to an initial conversion price of approximately $198.58 per share of the Company’s common stock. The conversion rate is subject to adjustment upon the occurrence of certain events but will not be adjusted for any accrued and unpaid interest. If the Company undergoes a fundamental change (as defined in the Indenture), holders may require the Company to repurchase for cash all or any portion of their 2023 Convertible Notes at a fundamental change repurchase price equal to 100% of the principal amount of the 2023 Convertible Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, if certain make-whole fundamental changes occur, the Company will, in certain circumstances, increase the conversion rate for any 2023 Convertible Notes converted in connection with such make-whole fundamental change. The Company may not redeem the 2023 Convertible Notes prior to July 6, 2021. The Company may redeem for cash all or part of the 2023 Convertible Notes, at its option, on or after July 6, 2021, if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the 2023 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. The Indenture provides for customary events of default. In accordance with ASC 470-20, the Company used an effective interest rate of 8.4% to determine the liability component of the 2023 Convertible Notes. This resulted in the recognition of $334.4 million as the liability component of the 2023 Convertible Notes and the recognition of the residual $113.1 million as the debt discount with a corresponding increase to additional paid-in capital for the equity component of the 2023 Convertible Notes. The fair value of the 2023 Convertible Notes was approximately $415.8 million and $363.7 million at June 30, 2021 and December 31, 2020, respectively, and was determined using Level 2 inputs based on quoted market values. Interest Expense on Convertible Notes The table summarizes the total interest expense recognized in the periods presented: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 (in thousands) (in thousands) Contractual interest expense $ 4,888 $ 4,888 $ 9,775 $ 9,775 Amortization of debt discount 7,016 6,417 13,877 12,693 Amortization of debt issuance costs 685 628 1,356 1,242 Total interest expense $ 12,589 $ 11,933 $ 25,008 $ 23,710 Accrued interest on the Convertible Notes was approximately $8.1 million and $8.1 million as of June 30, 2021 and December 31, 2020, respectively. The Company recorded debt issuance costs of $19.0 million, which are being amortized using the effective interest method. As of June 30, 2021, and December 31, 2020, $9.3 million and $10.7 million, respectively, of debt issuance costs are recorded on the condensed consolidated balance sheets in Long-term debt. Cash payments for interest were $9.8 million and $9.8 million for the six months ended June 30, 2021 and 2020, respectively. |
Product Revenue, Net
Product Revenue, Net | 6 Months Ended |
Jun. 30, 2021 | |
Product Revenue, Net [Abstract] | |
Product Revenue, Net | 11. Product Revenue, Net The Company recognized net sales of Ocaliva of $96.6 million and $77.2 million for the three months ended June 30, 2021 and 2020, respectively and $178.2 million and $149.9 million for the six months ended June 30, 2021 and 2020, respectively. The table below summarizes consolidated product revenue, net by region: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 (in thousands) (in thousands) Product revenue, net: U.S. $ 68,178 $ 59,629 $ 125,477 $ 110,408 ex-U.S. 28,398 17,620 52,760 39,493 Total product revenue, net $ 96,576 $ 77,249 $ 178,237 $ 149,901 Credit Losses The following table summarizes the allowance for credit losses activity on the Company’s trade receivables for the six-month period ended June 30, 2021 (in thousands): Balance at December 31, 2020 $ 235 Provision for credit losses 82 Write-offs (38) Balance at June 30, 2021 $ 279 |
Research and Development Tax Cr
Research and Development Tax Credit | 6 Months Ended |
Jun. 30, 2021 | |
Research and Development Tax Credit | |
Research and Development Tax Credit | 12. Research and Development Tax Credit The Company has benefited from the U.K. Small and Medium-sized Enterprise R&D Tax Credit scheme, or the SME scheme, under which it can obtain a tax credit of up to 33.4% of eligible research and development expenses incurred by the Company in the U.K. Eligible expenses generally include employment costs for research staff, consumables, software and certain internal overhead costs incurred as part of research projects. The Company submitted a claim seeking to obtain tax credits for qualifying R&D expenses incurred in the year ended December 31, 2017. In June 2020, the Company received a payment of $9.4 million from HMRC. Given the finalization and approval of the claim for 2017, the Company recorded the U.K. research and development tax credit payments received of $10.7 million (including $1.3 million due to foreign currency translation) as a reduction of research and development expense in the condensed consolidated statements of operations for the three and six months ended June 30, 2021. In the three and six months ended June 30, 2020, the Company recorded U.K. research and development tax credits of $22.0 million as a reduction of research and development expense. |
Restructuring Expenses
Restructuring Expenses | 6 Months Ended |
Jun. 30, 2021 | |
Restructuring Expenses | |
Restructuring Expenses | 13. Restructuring Expenses critical resources needed to continue to support the NASH and PBC clinical programs, pursue the approval of OCA for the treatment of liver fibrosis due to NASH and support the Company’s successful PBC business. The 2020 Workforce Plan resulted in a workforce reduction of approximately 25%, or approximately 170 employees. The 2020 Workforce Plan was implemented during the third quarter of 2020, immediately after its announcement, and was fully completed by the end of the second quarter in 2021 upon payments of cash for charges incurred under the 2020 Workforce Plan. In the three and six months ended June 30, 2021 the Company recorded restructuring benefits of $0.2 million and $0.1 million, respectively, which were primarily related to a reversal of unclaimed other related termination benefits recognized in conjunction with the 2020 Workforce Plan. The following table reflects total (benefits)/expenses related to restructuring activities recognized within the condensed consolidated statements of operations as restructuring costs: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 (in thousands) (in thousands) Employee compensation costs $ (249) $ — $ (92) $ — Equity compensation costs — — 4 — Total restructuring costs $ (249) $ — $ (88) $ — As of June 30, 2021, the cumulative restructuring costs incurred under the 2020 Workforce Plan were $14.5 million. In the three and six months ended June 30, 2021, the Company recorded an immaterial amount in non-cash stock-based compensation expense, in association with the acceleration of the vesting of certain options and restricted stock units (“RSUs”) held by terminated employees. Severance and Related Costs (in thousands) Accrued balance at December 31, 2020 $ 2,504 Charges incurred 180 Cash payments made (2,104) Other reserve adjustments (580) Accrued balance at June 30, 2021 $ — |
Stock Compensation
Stock Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Stock Compensation [Abstract] | |
Stock Compensation | 14. Stock Compensation The Company’s 2012 Equity Incentive Plan (“2012 Plan”) became effective upon the pricing of its initial public offering in October 2012. At the same time, the Company’s 2003 Stock Incentive Plan (“2003 Plan”) was terminated and 555,843 shares available under the 2003 Plan were added to the 2012 Plan. On January 1, 2021, the number of shares available for issuance under the 2012 Plan increased by 1,211,533 shares, as a result of the automatic increase provisions thereof. The estimated fair value of the stock options granted in the six months ended June 30, 2021 was determined utilizing a Black-Scholes option-pricing model at the date of grant. The fair value of the RSUs granted in the six months ended June 30, 2021 was determined utilizing the closing price of the Company’s common stock on the date of grant. The fair value of the performance restricted stock units (“PRSUs”) granted in the six months ended June 30, 2021 was determined utilizing the Monte Carlo simulation method. The Company accounts for all forfeitures when they occur. Ultimately, the actual expense recognized over the vesting period will be for only those shares that vest and are not forfeited. The Company has in the past, and may in the future, grant performance-based awards with vesting terms based on the achievement of specified goals. To the extent such awards do not contain a market condition, the Company recognizes no expense until achievement of the performance requirement is deemed probable. There are no awards with performance conditions outstanding as of June 30, 2021. The following table summarizes stock option activity during the six months ended June 30, 2021: Weighted Average Number Weighted Remaining Aggregate of Options Average Contractual Intrinsic Value (in thousands) Exercise Price Term (years) (in thousands) Outstanding at December 31, 2020 2,199 $ 96.92 6.9 $ 146 Granted 1,197 $ 26.85 — $ — Exercised (2) $ 8.67 — $ — Cancelled/forfeited (313) $ 61.87 — $ — Expired (291) $ 103.39 — $ — Outstanding at June 30, 2021 2,790 $ 70.18 7.6 $ 439 Expected to vest 1,452 $ 43.43 9.3 $ 439 Exercisable 1,337 $ 99.24 5.8 $ — The aggregate intrinsic value of options is calculated as the difference between the exercise price of the underlying options and the fair value of the Company’s common stock for those options that had exercise prices lower than the fair value of the Company’s common stock. As of June 30, 2021, the total compensation cost related to non-vested option awards not yet recognized is approximately $33.5 million with a weighted average remaining vesting period of 1.57 years. The Company estimated the fair value of stock options granted in the periods presented utilizing a Black-Scholes option-pricing model utilizing the following assumptions: Six Months Ended June 30, 2021 2020 Volatility 65.2 - 67.7 % 61.9 - 87.1 % Expected term (in years) 5.5 - 6.0 5.5 - 6.0 Risk-free rate 0.4 - 0.9 % 0.3 - 1.7 % Expected dividend yield — % — % The following table summarizes the aggregate RSU, restricted stock award (“RSA”), PRSU and performance restricted share award (“PRSA”) activity during the six months ended June 30, 2021: Weighted Number of Average Grant Date Awards Fair Value (in thousands) Non-vested awards at December 31, 2020 799 $ 72.43 Granted 940 $ 28.27 Vested (125) $ 60.92 Forfeited (309) $ 63.66 Non-vested awards at June 30, 2021 1,305 $ 44.06 As of June 30, 2021, there is approximately $44.6 million of total unrecognized compensation expense related to unvested RSUs, RSAs, PRSUs and PRSAs, which is expected to be recognized over a weighted average vesting period of 1.65 years. During the six months ended June 30, 2021, the Company granted a total of 176,794 PRSUs to certain of the Company’s executive officers (of which 34,000 were subsequently forfeited upon employee termination). The performance criterion for such PRSUs is based on the Total Shareholder Return (“TSR”) of the Company’s common stock relative to the TSR of the companies comprising the S&P Biotechnology Select Industry Index (the “TSR Peer Group”) over a 3-year performance period and is accounted for as a market condition under ASC Topic 718, Compensation – Stock Compensation The Company recorded approximately $0.4 million and $0.9 million of stock-based compensation related to such PRSUs granted during the three and six months ended June 30, 2021. Stock-based compensation expense has been reported in the Company’s condensed consolidated statements of operations as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 (in thousands) (in thousands) Selling, general and administrative $ 7,300 $ 12,249 $ 13,689 $ 21,972 Research and development 1,148 3,834 3,174 6,584 Restructuring — — 4 — Total stock-based compensation $ 8,448 $ 16,083 $ 16,867 $ 28,556 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2021 | |
Net loss per common and potential common share: | |
Net Loss Per Share | 15. Net Loss Per Share Basic loss per share is computed by dividing net loss attributable to common stockholders (numerator) by the weighted average number of common shares outstanding (denominator) during the period. For the three and six-month periods ended June 30, 2021 and 2020, as the Company was in a net loss position, the diluted loss per share computations for such periods did not assume the conversion of the Convertible Notes, exercise of stock options or vesting of RSUs or PRSUs as they would have had an anti-dilutive effect on loss per share. The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding for the three and six-month periods ended June 30, 2021 and 2020, as the inclusion thereof would have been anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 (in thousands) (in thousands) Shares issuable upon conversion of Convertible Notes 4,435 4,435 4,435 4,435 Options 2,729 2,422 2,727 2,492 Unvested restricted stock units 1,211 849 1,220 893 Total 8,375 7,706 8,382 7,820 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 16. Commitments and Contingencies Legal Proceedings The Company is involved in various disputes, legal proceedings and litigation in the course of its business, including the matters described below and, from time to time, governmental inquiries and investigations and employment and other litigation. These matters, which could result in damages, fines or other administrative, civil or criminal remedies, liabilities or penalties, are often complex and the outcome of such matters is often uncertain. The Company may from time to time enter into settlements to resolve such matters. Shareholder Litigation Separately, on December 1, 2017, a purported shareholder demand was made on the Company based on substantially the same allegations as those set forth in the securities case above. In addition, on January 5, 2018, a follow-on derivative suit, styled Davis v. Pruzanski, et al., was filed in New York state court by shareholder Gregg Davis based on substantially the same allegations as those set forth in the securities case above. The court has entered an order staying the derivative litigation pending the outcome of the related securities case. On November 5, 2020, a purported shareholder class action, initially styled Chauhan v. Intercept Pharmaceuticals, Inc., et al., was filed in the United States District Court for the Eastern District of New York, naming the Company and certain of its officers as defendants. The lawsuit was transferred to the United States District Court for the Southern District of New York on January 4, 2021. The Court appointed lead plaintiff in the lawsuit on January 25, 2021, and the lead plaintiff filed a corrected amended complaint on March 15, 2021, captioned Richard Rice, as Trustee of the Richard E. and Melinda Rice Revocable Family Trust 5/9/90, and Christian Stankevitz v. Intercept Pharmaceuticals, Inc., et al., naming the Company and certain of its current and former officers as defendants. The lead plaintiff claims to be suing on behalf of anyone who purchased or otherwise acquired the Company’s securities between September 28, 2019 and October 7, 2020. This lawsuit alleges that material misrepresentations and/or omissions of material fact were made in the Company’s public disclosures during the period from September 28, 2019 to October 7, 2020, in violation of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The alleged improper disclosures relate to statements regarding the Company’s New Drug Application for OCA for the treatment of liver fibrosis due to NASH and the use of Ocaliva in patients with PBC, as well as the Company’s operations, financial performance and prospects. The plaintiff seeks unspecified monetary damages on behalf of the putative class, and an award of costs and expenses, including attorney’s fees. On April 26, 2021, the Company filed a motion to dismiss the amended complaint. On May 26, 2021, the plaintiff filed an opposition to the motion to dismiss, and on June 9, 2021, the Company filed a reply brief. Separately, on December 29, 2020, a follow-on derivative suit, styled Rabinovich v. Fundarò, et al., was filed in the United States District Court for the Southern District of New York by shareholder Delfin Rabinovich based on substantially the same allegations as those set forth in the securities case immediately above. This lawsuit was subsequently transferred to the United States District Court for the District of Delaware on January 28, 2021. On February 1, 2021, a second follow-on derivative suit, styled Fung v. Fundarò, et al., was filed in the United States District Court for the District of Delaware based on the substantially same allegations as those set forth in the securities case immediately above and the Rabinovich derivative action. On March 1, 2021, these follow-on derivative suits were consolidated in a single suit titled In re Intercept Pharmaceuticals, Inc. Derivative Litigation. On March 15, 2021, the District of Delaware entered an order staying the consolidated derivative litigation pending a decision on the motion to dismiss in the related securities case. While the Company believes that it has a number of valid defenses to the claims described above and intends to vigorously defend itself, the matters are in the early stages of litigation and no assessment can be made as to the likely outcome of the matters or whether they will be material to the Company. Accordingly, an estimate of the potential loss, or range of loss, if any, to the Company relating to the matters is not possible at this time. Patent Litigation The Company has received paragraph IV certification notice letters from six generic drug manufacturers indicating that each such manufacturer has submitted to the FDA an Abbreviated New Drug Application (“ANDA”) seeking approval to manufacture and sell a generic version of the Company’s 5 mg and 10 mg dosage strengths of Ocaliva® (obeticholic acid) for PBC prior to the expiration of certain patents protecting Ocaliva. Apotex Abbreviated New Drug Application In July 2020, the Company received a paragraph IV certification notice (the “Apotex PIV Notice”) from Apotex Inc. (“Apotex”) indicating that Apotex has submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of the Company’s 5 mg and 10 mg dosage strengths of Ocaliva® (obeticholic acid) for PBC prior to the expiration of the Company’s U.S. Patents Nos. 9,238,673 (the “‘673 Patent”), 10,047,117 (the “‘117 Patent”), 10,052,337 (the “‘337 Patent”), and 10,174,073 (the “‘073 Patent”, and collectively with the ‘673 Patent, ‘117 Patent and ‘337 Patent, the “Apotex Challenged Patents”), which are listed for Ocaliva in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (referred to as the “Orange Book”). The Apotex PIV Notice alleges that the Apotex Challenged Patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic products described in Apotex’s ANDA. Apotex did not make a paragraph IV certification against the Company’s U.S. Patents Nos. 7,138,390 (the “‘390 Patent”), 8,058,267 (the “‘267 Patent”) or 8,377,916 the (“‘916 Patent”), which are also listed for Ocaliva in the Orange Book. The Company initiated a patent infringement suit against Apotex in the United States District Court for the District of Delaware within 45 days of receipt of the Apotex PIV Notice. As a result, under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), the FDA cannot grant final approval of Apotex’s ANDA before November 27, 2023 or a court decision in Apotex’s favor, whichever is earlier. Recently, the U.S. Patent and Trademark Office (the “USPTO”) awarded the Company two additional patents that were subsequently listed in the Orange Book for Ocaliva: U.S. Patents Nos. 10,751,349 (the “‘349 Patent”) and 10,758,549 (the “‘549 Patent”). In September and October 2020, the Company received additional paragraph IV certification notices from Apotex challenging the ‘349 Patent and the ‘549 Patent, respectively. The Company amended its complaint against Apotex in November 2020 to add infringement allegations for the ‘549 Patent. In January 2021, the Company received a further paragraph IV certification notice from Apotex challenging a reissue patent, U.S. Patent No. RE 48,286 (the “‘286 Patent”), as described below. The Company further amended its complaint against Apotex in March 2021 to add infringement allegations for the ‘286 Patent. In response to the Company’s allegations of infringement, Apotex has taken the position that the patents asserted against it are invalid and/or not infringed. Lupin Abbreviated New Drug Application In July 2020, the Company received a paragraph IV certification notice (the “Lupin PIV Notice”) from Lupin Limited (“Lupin”) indicating that Lupin has submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of the Company’s 5 mg and 10 mg dosage strengths of Ocaliva® (obeticholic acid) for PBC prior to the expiration of the ‘390 Patent, the ‘673 Patent, the ‘117 Patent, the ‘337 Patent and the ‘073 Patent (collectively, the “Lupin Challenged Patents”), which are listed for Ocaliva in the FDA’s Orange Book. The Lupin PIV Notice alleges that the Lupin Challenged Patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic products described in Lupin’s ANDA. Lupin did not make a paragraph IV certification against the ‘267 Patent or the ‘916 Patent, which are also listed for Ocaliva in the Orange Book. The Company initiated a patent infringement suit against Lupin in the United States District Court for the District of Delaware within 45 days of receipt of the Lupin PIV Notice. As a result, under the Hatch-Waxman Act, the FDA cannot grant final approval of Lupin’s ANDA before November 27, 2023 or a court decision in Lupin’s favor, whichever is earlier. In September 2020, the Company received an additional paragraph IV certification notice from Lupin challenging the ‘349 Patent and the ‘549 Patent. In November 2020, the Company received an additional amended paragraph IV certification notice from Lupin challenging the ‘286 Patent. The Company amended its complaint against Lupin in November 2020 to add infringement allegations for the ‘549 Patent and to substitute the ‘286 Patent for the ‘390 Patent. In response to the Company’s allegations of infringement, Lupin has taken the position that the patents asserted against it are invalid and/or not infringed. Amneal Abbreviated New Drug Application In July 2020, the Company received a paragraph IV certification notice (the “Amneal PIV Notice”) from Amneal Pharmaceuticals of New York, LLC, as U.S. agent for Amneal EU Limited (“Amneal”), indicating that Amneal has submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of the Company’s 5 mg and 10 mg dosage strengths of Ocaliva® (obeticholic acid) for PBC prior to the expiration of the ‘673 Patent, the ‘117 Patent, the ‘337 Patent and the ‘073 Patent (collectively, the “Amneal Challenged Patents”), which are listed for Ocaliva in the FDA’s Orange Book. The Amneal PIV Notice alleges that the Amneal Challenged Patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic products described in Amneal’s ANDA. Amneal did not make a paragraph IV certification against the ‘390 Patent, the ‘267 Patent or the ‘916 Patent, which are also listed for Ocaliva in the Orange Book. The Company initiated a patent infringement suit against Amneal in the United States District Court for the District of Delaware within 45 days of receipt of the Amneal PIV Notice. As a result, under the Hatch-Waxman Act, the FDA cannot grant final approval of Amneal’s ANDA before November 27, 2023 or a court decision in Amneal’s favor, whichever is earlier. In October 2020, the Company received an additional paragraph IV certification notice from Amneal challenging the ‘349 Patent and the ‘549 Patent. The Company amended its complaint against Amneal in November 2020 to add infringement allegations for the ‘349 Patent and the ‘549 Patent. In response to the Company’s allegations of infringement, Amneal has taken the position that the patents asserted against it are invalid and/or not infringed. Optimus Abbreviated New Drug Application In July 2020, the Company received a paragraph IV certification notice (the “Optimus PIV Notice”) from Optimus Pharma Pvt Ltd (“Optimus”) indicating that Optimus has submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of the Company’s 5 mg and 10 mg dosage strengths of Ocaliva® (obeticholic acid) for PBC prior to the expiration of the ‘390 Patent, the ‘673 Patent, the ‘117 Patent, the ‘337 Patent and the ‘073 Patent (collectively, the “Optimus Challenged Patents”) which are listed for Ocaliva in the FDA’s Orange Book. The Optimus PIV Notice alleges that the Optimus Challenged Patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic products described in Optimus’s ANDA. Optimus did not make a paragraph IV certification against the ‘267 Patent or the ‘916 Patent, which are also listed for Ocaliva in the Orange Book. The Company initiated a patent infringement suit against Optimus in the United States District Court for the District of Delaware within 45 days of receipt of the Optimus PIV Notice. As a result, under the Hatch-Waxman Act, the FDA cannot grant final approval of Optimus’s ANDA before November 27, 2023 or a court decision in Optimus’s favor, whichever is earlier. In October 2020, the Company received an additional paragraph IV certification notice from Optimus challenging the ‘349 Patent and the ‘549 Patent. The Company amended its complaint against Optimus in November 2020 to add infringement allegations for the ‘549 Patent and to substitute the ‘286 Patent for the ‘390 Patent. In response to the Company’s allegations of infringement, Optimus has taken the position that the patents asserted against it are invalid and/or not infringed. MSN Abbreviated New Drug Application In July 2020, the Company received a paragraph IV certification notice (the “MSN PIV Notice”) from MSN Pharmaceuticals Inc. and MSN Laboratories Private Limited (collectively, “MSN”) indicating that MSN has submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of the Company’s 5 mg and 10 mg dosage strengths of Ocaliva® (obeticholic acid) for PBC prior to the expiration of the ‘390 Patent, the ‘673 Patent, the ‘117 Patent, the ‘337 Patent and the ‘073 Patent (collectively, the “MSN Challenged Patents”) which are listed for Ocaliva in the FDA’s Orange Book. The MSN PIV Notice alleges that the MSN Challenged Patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic products described in MSN’s ANDA. MSN did not make a paragraph IV certification against the ‘267 Patent or the ‘916 Patent, which are also listed for Ocaliva in the Orange Book. The Company initiated a patent infringement suit against MSN in the United States District Court for the District of Delaware within 45 days of receipt of the MSN PIV Notice. As a result, under the Hatch-Waxman Act, the FDA cannot grant final approval of MSN’s ANDA before November 27, 2023 or a court decision in MSN’s favor, whichever is earlier. In November 2020, the Company received an additional paragraph IV certification notice from MSN challenging the ‘349 Patent, the ‘549 Patent, and the ‘286 Patent. The Company amended its complaint against MSN in December 2020 to add infringement allegations for the ‘549 Patent and to substitute the ‘286 Patent for the ‘390 Patent. In response to the Company’s allegations of infringement, MSN has taken the position that the patents asserted against it are invalid and/or not infringed. DRL Abbreviated New Drug Application In December 2020, the Company received a paragraph IV certification notice (the “DRL PIV Notice”) from Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (collectively, “DRL”) indicating that DRL has submitted to the FDA an ANDA seeking approval to manufacture and sell a generic version of the Company’s 5 mg and 10 mg dosage strengths of Ocaliva® (obeticholic acid) for PBC prior to the expiration of the ‘286 Patent, the ‘390 Patent, the ‘673 Patent, the ‘117 Patent, the ‘337 Patent, the ‘073 Patent, the ‘349 Patent and the ‘549 Patent (collectively, the “DRL Challenged Patents”) which are listed for Ocaliva in the FDA’s Orange Book. The DRL PIV Notice alleges that the DRL Challenged Patents are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale of the generic products described in DRL’s ANDA. DRL did not make a paragraph IV certification against the ‘267 Patent or the ‘916 Patent, which are also listed for Ocaliva in the Orange Book. The Company initiated a patent infringement suit against DRL in the United States District Court for the District of Delaware within 45 days of receipt of the DRL PIV Notice. As a result, under the Hatch-Waxman Act, the FDA cannot grant final approval of DRL’s ANDA before November 27, 2023 or a court decision in DRL’s favor, whichever is earlier. In response to the Company’s allegations of infringement, DRL has taken the position that the patents asserted against it are invalid and/or not infringed. In October 2020, the USPTO granted to the Company a reissue patent, ‘286 Patent. By operation of law, the ‘390 Patent was withdrawn and replaced by the ‘286 Patent, which contains composition of matter claims to OCA and has the same term as the ‘390 Patent. In February 2021, a patent term extension certificate was issued, which extends the term of the ‘286 Patent into 2027. The ‘286 Patent has been listed in the Orange Book. Trial against all of the generic challengers is scheduled for February 27, 2023. These proceedings are costly and time consuming. Successful challenges to the Company’s patent or other intellectual property rights through these proceedings could result in a loss of rights in the relevant jurisdiction and may allow third parties to use the Company’s proprietary technologies without a license from the Company or its collaborators. While the Company intends to vigorously defend and enforce its intellectual property rights protecting Ocaliva, the Company can offer no assurance as to when the lawsuits will be decided, whether the lawsuits will be successful, or that a generic equivalent of Ocaliva will not be approved and enter the market before the expiration of the Company’s patents. |
Basis of Presentation (Policy)
Basis of Presentation (Policy) | 6 Months Ended |
Jun. 30, 2021 | |
Basis of Presentation [Abstract] | |
Use of Estimates | Use of Estimates The preparation of these unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from these estimates. We are not presently aware of any events or circumstances arising from the coronavirus (“COVID-19”) pandemic that would require us to update our estimates or judgments or revise the carrying value of our assets or liabilities. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Significant Accounting Policiies | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”), which is intended to simplify various aspects related to accounting for income taxes. ASU 2019-12 removes certain exceptions to the general principles in Topic 740 and also clarifies and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The Company adopted ASU 2019-12 on January 1, 2021 and its adoption did not have any material impact on the Company’s condensed consolidated financial statements and related disclosures. Recent Accounting Pronouncements to be Adopted In August 2020, the FASB issued ASU No. 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required under current U.S. GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. Either a modified retrospective method of transition or a fully retrospective method of transition is permissible for the adoption of this standard. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2021, with early adoption permitted. The Company expects the impact of this standard to be material on its consolidated financial statements and related disclosures . |
Fair Value Measurements (Policy
Fair Value Measurements (Policy) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Measurements [Abstract] | |
Fair Value of Financial Instruments | The carrying amounts of the Company’s receivables and payables approximate their fair value due to their short maturities. Accounting principles provide guidance for using fair value to measure assets and liabilities. The guidance includes a three-level hierarchy of valuation techniques used to measure fair value, defined as follows: ● Unadjusted Quoted Prices — The fair value of an asset or liability is based on unadjusted quoted prices in active markets for identical assets or liabilities (Level 1). ● Pricing Models with Significant Observable Inputs — The fair value of an asset or liability is based on information derived from either an active market quoted price, which may require further adjustment based on the attributes of the financial asset or liability being measured, or an inactive market transaction (Level 2). ● Pricing Models with Significant Unobservable Inputs — The fair value of an asset or liability is primarily based on internally derived assumptions surrounding the timing and amount of expected cash flows for the financial instrument. Therefore, these assumptions are unobservable in either an active or inactive market (Level 3). The Company considers an active market as one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. Conversely, the Company views an inactive market as one in which there are few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers. Where appropriate, non-performance risk, or that of a counterparty, is considered in determining the fair values of liabilities and assets, respectively. The Company’s money market funds are classified within Level 1 of the fair value hierarchy because they are valued using quoted prices in active markets. Investment debt securities are classified as Level 2 instruments based on market pricing and other observable inputs. |
Cash, Cash Equivalents and In_2
Cash, Cash Equivalents and Investment Debt Securities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Cash, Cash Equivalents, and Investment Debt Securities [Abstract] | |
Cash, Cash Equivalents and Investment Debt Securities | The following table summarizes the Company’s cash, cash equivalents and investment debt securities as of June 30, 2021 and December 31, 2020: As of June 30, 2021 Allowance Gross Gross for Credit Unrealized Unrealized Amortized Cost Losses Gains Losses Fair Value (in thousands) Cash and cash equivalents: Cash and money market funds $ 145,620 $ — $ — $ — $ 145,620 Total cash and cash equivalents 145,620 — — — 145,620 Investment debt securities: Commercial paper 53,334 — 2 (2) 53,334 Corporate debt securities 215,375 — 125 (31) 215,469 Total investment debt securities 268,709 — 127 (33) 268,803 Total cash, cash equivalents and investment debt securities $ 414,329 $ — $ 127 $ (33) $ 414,423 As of December 31, 2020 Allowance Gross Gross for Credit Unrealized Unrealized Amortized Cost Losses Gains Losses Fair Value (in thousands) Cash and cash equivalents: Cash and money market funds $ 58,151 $ — $ — $ — $ 58,151 Total cash and cash equivalents 58,151 — — — 58,151 Investment debt securities: Commercial paper 55,460 — 6 (9) 55,457 Corporate debt securities 355,597 — 529 (67) 356,059 Total investment debt securities 411,057 — 535 (76) 411,516 Total cash, cash equivalents and investment debt securities $ 469,208 $ — $ 535 $ (76) $ 469,667 |
Available-for-sale Securities, Continuous Unrealized Loss Position, Fair Value | As of June 30, 2021 Less than 12 months 12 months or longer Total (in thousands) Gross Gross Gross Unrealized Unrealized Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Commercial paper $ 17,338 $ (2) $ — $ — $ 17,338 $ (2) Corporate debt securities 119,980 (31) — — 119,980 (31) Total $ 137,318 $ (33) $ — $ — $ 137,318 $ (33) As of December 31, 2020 Less than 12 months 12 months or longer Total (in thousands) Gross Gross Gross Unrealized Unrealized Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Commercial paper $ 32,970 $ (9) $ — $ — $ 32,970 $ (9) Corporate debt securities 143,076 (67) — — 143,076 (67) Total $ 176,046 $ (76) $ — $ — $ 176,046 $ (76) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Measurements [Abstract] | |
Fair Value, Marketable Securities Measured on Recurring and Nonrecurring Basis | Financial assets carried at fair value are classified in the tables below in one of the three categories described above: Fair Value Measurements Using Total Level 1 Level 2 Level 3 (in thousands) June 30, 2021 Assets Cash and cash equivalents: Money market funds $ 81,733 $ 81,733 $ — $ — Available-for-sale investment debt securities: Commercial paper 53,334 — 53,334 — Corporate debt securities 215,469 — 215,469 — Total financial assets $ 350,536 $ 81,733 $ 268,803 $ — December 31, 2020 Assets Cash and cash equivalents: Money market funds $ 15,492 $ 15,492 $ — $ — Available-for-sale investment debt securities: Commercial paper 55,457 — 55,457 — Corporate debt securities 356,059 — 356,059 — Total financial assets $ 427,008 $ 15,492 $ 411,516 $ — |
Schedule of Available for Sale Securities Debt Maturities | The aggregate fair value of all available-for-sale investment debt securities (commercial paper and corporate debt securities), by contractual maturity, are as follows: Fair Value as of June 30, 2021 December 31, 2020 (in thousands) Due in one year or less $ 252,425 $ 328,077 Due after one year through two years 16,378 83,439 Total investment debt securities $ 268,803 $ 411,516 |
Fixed Assets, Net (Tables)
Fixed Assets, Net (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fixed Assets, Net [Abstract] | |
Fixed Assets, Net | Fixed assets are stated at cost and depreciated or amortized using the straight-line method based on useful lives as follows: Useful lives (Years) June 30, 2021 December 31, 2020 (in thousands) Office equipment and software 3 $ 5,390 $ 5,364 Leasehold improvements Shorter of remaining lease term or useful life 13,250 13,237 Furniture and fixtures 7 4,610 4,602 Subtotal 23,250 23,203 Less: accumulated depreciation (18,640) (16,877) Fixed assets, net $ 4,610 $ 6,326 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory [Abstract] | |
Schedule of Inventory | Inventories are stated at the lower of cost or market. Inventories consisted of the following: June 30, 2021 December 31, 2020 (in thousands) Work-in-process $ 8,400 $ 8,394 Finished goods 604 633 Inventory $ 9,004 $ 9,027 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Schedule of operating lease assets and liabilities | Operating lease assets and liabilities are classified on the condensed consolidated balance sheets as follows: Leases Classification June 30, 2021 December 31, 2020 Assets (in thousands) Operating lease assets Other assets $ 9,822 $ 12,327 Total leased assets $ 9,822 $ 12,327 Liabilities Current Operating lease liabilities Accounts payable, accrued expenses and other liabilities $ 6,127 $ 7,248 Noncurrent Operating lease liabilities Long-term other liabilities 5,323 7,684 Total operating lease liabilities $ 11,450 $ 14,932 |
Schedule of operating lease costs | Operating lease costs for the three and six-month periods ended June 30, 2021 and 2020, are as follows: Three Months Ended June 30, Six Months Ended June 30, Lease Cost Classification 2021 2020 2021 2020 (in thousands) (in thousands) Operating lease cost Selling, general and administrative expenses $ 1,569 $ 1,730 $ 3,254 $ 3,469 Short-term lease cost Selling, general and administrative expenses 515 1,542 1,154 1,963 Variable lease cost Selling, general and administrative expenses 211 364 592 611 Sublease expense (income) Other income, net — 6 — (114) Net lease cost $ 2,295 $ 3,642 $ 5,000 $ 5,929 |
Schedule of maturities of the company's operating lease liabilities | Maturities of the Company’s operating lease liabilities, which do not include short-term leases, as of June 30, 2021 are as follows: Maturity of Lease Liabilities Operating leases (in thousands) 2021 (remaining) $ 4,045 2022 3,615 2023 2,150 2024 1,616 2025 1,033 Thereafter — Total lease payments 12,459 Less: Present value discount (1,009) Total operating lease liabilities $ 11,450 |
Accounts Payable, Accrued Exp_2
Accounts Payable, Accrued Expenses and Other Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounts Payable, Accrued Expenses and Other Liabilities [Abstract] | |
Schedule of Accounts Payable and Accrued Liabilities | Accounts payable, accrued expenses and other liabilities consisted of the following: June 30, 2021 December 31, 2020 (in thousands) Accounts payable $ 15,092 $ 24,594 Accrued employee compensation 20,407 27,154 Accrued contracted services 46,026 62,425 Accrued restructuring — 2,504 Accrued rebates, discounts and other incentives 41,247 38,172 Operating lease liabilities 6,127 7,248 Other liabilities 8,345 8,942 Accounts payable, accrued expenses and other liabilities $ 137,244 $ 171,039 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Long-Term Debt [Abstract] | |
Schedule of Long-term Debt Instruments | Debt, net of discounts and deferred financing costs, consisted of the following: June 30, 2021 December 31, 2020 (in thousands) 2023 Convertible Notes $ 460,000 $ 460,000 2026 Convertible Notes 230,000 230,000 Long-term debt, gross 690,000 690,000 Less: Unamortized debt discounts and fees (114,185) (129,418) Long-term debt, net $ 575,815 $ 560,582 Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 (in thousands) (in thousands) Contractual interest expense $ 4,888 $ 4,888 $ 9,775 $ 9,775 Amortization of debt discount 7,016 6,417 13,877 12,693 Amortization of debt issuance costs 685 628 1,356 1,242 Total interest expense $ 12,589 $ 11,933 $ 25,008 $ 23,710 |
Product Revenue, Net (Tables)
Product Revenue, Net (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Product Revenue, Net [Abstract] | |
Product Revenues | The table below summarizes consolidated product revenue, net by region: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 (in thousands) (in thousands) Product revenue, net: U.S. $ 68,178 $ 59,629 $ 125,477 $ 110,408 ex-U.S. 28,398 17,620 52,760 39,493 Total product revenue, net $ 96,576 $ 77,249 $ 178,237 $ 149,901 |
Schedule of allowance for credit losses | The following table summarizes the allowance for credit losses activity on the Company’s trade receivables for the six-month period ended June 30, 2021 (in thousands): Balance at December 31, 2020 $ 235 Provision for credit losses 82 Write-offs (38) Balance at June 30, 2021 $ 279 |
Restructuring Expenses (Tables)
Restructuring Expenses (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Restructuring Expenses | |
Restructuring expenses activities | The following table reflects total (benefits)/expenses related to restructuring activities recognized within the condensed consolidated statements of operations as restructuring costs: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 (in thousands) (in thousands) Employee compensation costs $ (249) $ — $ (92) $ — Equity compensation costs — — 4 — Total restructuring costs $ (249) $ — $ (88) $ — Severance and Related Costs (in thousands) Accrued balance at December 31, 2020 $ 2,504 Charges incurred 180 Cash payments made (2,104) Other reserve adjustments (580) Accrued balance at June 30, 2021 $ — |
Stock Compensation (Tables)
Stock Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Stock Compensation [Abstract] | |
Schedule of Share Based Compensation Stock Options Activities | The following table summarizes stock option activity during the six months ended June 30, 2021: Weighted Average Number Weighted Remaining Aggregate of Options Average Contractual Intrinsic Value (in thousands) Exercise Price Term (years) (in thousands) Outstanding at December 31, 2020 2,199 $ 96.92 6.9 $ 146 Granted 1,197 $ 26.85 — $ — Exercised (2) $ 8.67 — $ — Cancelled/forfeited (313) $ 61.87 — $ — Expired (291) $ 103.39 — $ — Outstanding at June 30, 2021 2,790 $ 70.18 7.6 $ 439 Expected to vest 1,452 $ 43.43 9.3 $ 439 Exercisable 1,337 $ 99.24 5.8 $ — |
Schedule of Share Based Compensation Arrangement By Share Based Payment Award Grants in Period Fair Value Assumptions | The Company estimated the fair value of stock options granted in the periods presented utilizing a Black-Scholes option-pricing model utilizing the following assumptions: Six Months Ended June 30, 2021 2020 Volatility 65.2 - 67.7 % 61.9 - 87.1 % Expected term (in years) 5.5 - 6.0 5.5 - 6.0 Risk-free rate 0.4 - 0.9 % 0.3 - 1.7 % Expected dividend yield — % — % |
Schedule of Share-based Compensation, Restricted Stock Units Award Activity | The following table summarizes the aggregate RSU, restricted stock award (“RSA”), PRSU and performance restricted share award (“PRSA”) activity during the six months ended June 30, 2021: Weighted Number of Average Grant Date Awards Fair Value (in thousands) Non-vested awards at December 31, 2020 799 $ 72.43 Granted 940 $ 28.27 Vested (125) $ 60.92 Forfeited (309) $ 63.66 Non-vested awards at June 30, 2021 1,305 $ 44.06 |
Schedule of Stock Based Compensation Expense | Stock-based compensation expense has been reported in the Company’s condensed consolidated statements of operations as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 (in thousands) (in thousands) Selling, general and administrative $ 7,300 $ 12,249 $ 13,689 $ 21,972 Research and development 1,148 3,834 3,174 6,584 Restructuring — — 4 — Total stock-based compensation $ 8,448 $ 16,083 $ 16,867 $ 28,556 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Net loss per common and potential common share: | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding for the three and six-month periods ended June 30, 2021 and 2020, as the inclusion thereof would have been anti-dilutive: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 (in thousands) (in thousands) Shares issuable upon conversion of Convertible Notes 4,435 4,435 4,435 4,435 Options 2,729 2,422 2,727 2,492 Unvested restricted stock units 1,211 849 1,220 893 Total 8,375 7,706 8,382 7,820 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Narrative) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Accrued rebates, discounts and other incentives | $ 41,247 | $ 38,172 |
Europe [Member] | ||
Accrued rebates, discounts and other incentives | $ 32,100 | $ 27,400 |
Cash, Cash Equivalents and In_3
Cash, Cash Equivalents and Investment Debt Securities (Narrative) (Details) $ in Millions | Jun. 30, 2021USD ($)security | Dec. 31, 2020USD ($) |
Cash, Cash Equivalents, and Investment Debt Securities [Abstract] | ||
Number of positions that were in a continuous unrealized loss position for more than twelve months | security | 53 | |
Accrued investment income receivable | $ | $ 1.5 | $ 2.5 |
Cash, Cash Equivalents and In_4
Cash, Cash Equivalents and Investment Debt Securities (Cash, Cash Equivalents and Investment Debt Securities) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Cash and cash equivalents: | ||
Cash and Cash Equivalents, Amortized Cost | $ 145,620 | $ 58,151 |
Cash and cash equivalents, Fair Value | 145,620 | 58,151 |
Investment Debt Securities Abstract | ||
Total investments, Amortized Cost | 268,709 | 411,057 |
Total cash and cash equivalents and investment debt securities, Amortized Cost | 414,329 | 469,208 |
Allowance for Credit Losses | 0 | |
Total investments, Gross Unrealized Gains | 127 | 535 |
Total cash and cash equivalents and investment debt securities, Gross Unrealized Gains | 127 | |
Total investments, Gross Unrealized Losses | (33) | (76) |
Total cash and cash equivalents and investment debt securities, Gross Unrealized Losses | (33) | |
Total investments, Fair Value | 268,803 | 411,516 |
Total cash and cash equivalents and investment debt securities, Fair Value | 414,423 | 469,667 |
Commercial Paper [Member] | ||
Investment Debt Securities Abstract | ||
Total investments, Amortized Cost | 53,334 | 55,460 |
Allowance for Credit Losses | 0 | |
Total investments, Gross Unrealized Gains | 2 | 6 |
Total investments, Gross Unrealized Losses | (2) | (9) |
Total investments, Fair Value | 53,334 | 55,457 |
Corporate Debt Securities [Member] | ||
Investment Debt Securities Abstract | ||
Total investments, Amortized Cost | 215,375 | 355,597 |
Allowance for Credit Losses | 0 | |
Total investments, Gross Unrealized Gains | 125 | 529 |
Total investments, Gross Unrealized Losses | (31) | (67) |
Total investments, Fair Value | 215,469 | 356,059 |
Cash and Money Market Funds [Member] | ||
Cash and cash equivalents: | ||
Cash and Cash Equivalents, Amortized Cost | 145,620 | $ 58,151 |
Cash and cash equivalents, Fair Value | $ 145,620 |
Cash, Cash Equivalents, and Inv
Cash, Cash Equivalents, and Investments (Available-for-sale Securities, Continuous Unrealized Loss Position, Fair Value) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Total available for sale securities, Less than 12 months, Fair Value | $ 137,318 | $ 176,046 |
Total available for sale securities Less than 12 months, Gross Unrealized Holding Losses | (33) | (76) |
Total available for sale securities, More than 12 months, Fair Value | 0 | 0 |
Total available for sale securities more than 12 months, Gross Unrealized Holding Losses | 0 | 0 |
Available-for-sale securities, Total Fair Value | 137,318 | 176,046 |
Available-for-sale securities, Total Gross Unrealized Losses | (33) | (76) |
Commercial Paper [Member] | ||
Total available for sale securities, Less than 12 months, Fair Value | 17,338 | 32,970 |
Total available for sale securities Less than 12 months, Gross Unrealized Holding Losses | (2) | (9) |
Total available for sale securities, More than 12 months, Fair Value | 0 | 0 |
Total available for sale securities more than 12 months, Gross Unrealized Holding Losses | 0 | 0 |
Available-for-sale securities, Total Fair Value | 17,338 | 32,970 |
Available-for-sale securities, Total Gross Unrealized Losses | (2) | (9) |
Corporate Debt Securities [Member] | ||
Total available for sale securities, Less than 12 months, Fair Value | 119,980 | 143,076 |
Total available for sale securities Less than 12 months, Gross Unrealized Holding Losses | (31) | (67) |
Total available for sale securities, More than 12 months, Fair Value | 0 | 0 |
Total available for sale securities more than 12 months, Gross Unrealized Holding Losses | 0 | 0 |
Available-for-sale securities, Total Fair Value | 119,980 | 143,076 |
Available-for-sale securities, Total Gross Unrealized Losses | $ (31) | $ (67) |
Fair Value Measurements (Narrat
Fair Value Measurements (Narrative) (Details) - Convertible Debt [Member] | Jun. 30, 2021 |
Convertible Senior Notes 3.25% Due 2023 [Member] | |
Debt instrument, interest rate, stated percentage | 3.25% |
Convertible Senior Notes 2.00% Due 2026 [Member] | |
Debt instrument, interest rate, stated percentage | 2.00% |
Fair Value Measurements (Fair V
Fair Value Measurements (Fair Value, Marketable Securities Measured on Recurring and Nonrecurring Basis) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Cash and cash equivalents, fair value disclosure | $ 145,620 | $ 58,151 |
Available-for-sale securities, fair value disclosure | 268,803 | 411,516 |
Total financial assets | 350,536 | 427,008 |
Fair Value, Inputs, Level 1 [Member] | ||
Total financial assets | 81,733 | 15,492 |
Fair Value, Inputs, Level 2 [Member] | ||
Total financial assets | 268,803 | 411,516 |
Fair Value, Inputs, Level 3 [Member] | ||
Total financial assets | 0 | 0 |
Money Market Funds [Member] | ||
Cash and cash equivalents, fair value disclosure | 81,733 | 15,492 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Cash and cash equivalents, fair value disclosure | 81,733 | 15,492 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Cash and cash equivalents, fair value disclosure | 0 | 0 |
Corporate Debt Securities [Member] | ||
Available-for-sale securities, fair value disclosure | 215,469 | 356,059 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Available-for-sale securities, fair value disclosure | 0 | 0 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Available-for-sale securities, fair value disclosure | 215,469 | 356,059 |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Available-for-sale securities, fair value disclosure | 0 | 0 |
Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | ||
Available-for-sale securities, fair value disclosure | 53,334 | 55,457 |
Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Available-for-sale securities, fair value disclosure | 0 | 0 |
Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Available-for-sale securities, fair value disclosure | 53,334 | 55,457 |
Commercial Paper, Not Included with Cash and Cash Equivalents [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Available-for-sale securities, fair value disclosure | $ 0 | $ 0 |
Fair Value Measurements (Schedu
Fair Value Measurements (Schedule of Available for Sale Securities Debt Maturities) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Fair Value Measurements [Abstract] | ||
Due in one year or less | $ 252,425 | $ 328,077 |
Due after one year through two years | 16,378 | 83,439 |
Total investment debt securities | $ 268,803 | $ 411,516 |
Fixed Assets, Net (Fixed Assets
Fixed Assets, Net (Fixed Assets Stated at Cost) (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Fixed assets | $ 23,250 | $ 23,203 |
Less: accumulated depreciation | (18,640) | (16,877) |
Fixed assets, net | 4,610 | 6,326 |
Office Equipment [Member] | ||
Fixed assets | $ 5,390 | 5,364 |
Property, Plant and Equipment, Useful Life | 3 years | |
Leasehold Improvements [Member] | ||
Fixed assets | $ 13,250 | 13,237 |
Property, Plant and Equipment, Estimated Useful Lives | Shorter of remaining lease term or useful life | |
Furniture and Fixtures [Member] | ||
Fixed assets | $ 4,610 | $ 4,602 |
Property, Plant and Equipment, Useful Life | 7 years |
Inventory (Schedule of Inventor
Inventory (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory [Abstract] | ||
Work-in-process | $ 8,400 | $ 8,394 |
Finished goods | 604 | 633 |
Inventory | $ 9,004 | $ 9,027 |
Leases (Details)
Leases (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Leases [Abstract] | ||
Operating lease, existence of option to extend | true | |
Operating leases, weighted-average remaining term | 2 years 7 months 6 days | |
Operating leases, weighted-average discount rate | 5.20% | |
Cash payments included in the measurement of the Company's lease liabilities | $ 4,200 | $ 3,800 |
Right-of-use asset obtained in exchange for new operating lease obligations | $ 0 | 1,006 |
Increase (decrease) in operating lease liability | $ 1,000 |
Leases (Assets and Liabilities)
Leases (Assets and Liabilities) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Operating lease assets | $ 9,822 | $ 12,327 |
Other assets - extensible list location | us-gaap:OtherAssets | us-gaap:OtherAssets |
Total leased assets | $ 9,822 | $ 12,327 |
Operating lease liabilities, current | $ 6,127 | $ 7,248 |
Accounts payable, accrued expenses and other liabilities - extensible list location | us-gaap:AccountsPayableAndOtherAccruedLiabilities | us-gaap:AccountsPayableAndOtherAccruedLiabilities |
Operating lease liabilities, Noncurrent | $ 5,323 | $ 7,684 |
Long-term other liabilities - extensible list location | Long-term other liabilities | Long-term other liabilities |
Total operating lease liabilities | $ 11,450 | $ 14,932 |
Leases (Lease Cost, Term and Di
Leases (Lease Cost, Term and Discount Rate) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Lease Cost | ||||
Net lease cost | $ 2,295 | $ 3,642 | $ 5,000 | $ 5,929 |
Selling, General and Administrative Expenses [Member] | ||||
Lease Cost | ||||
Operating lease cost | 1,569 | 1,730 | 3,254 | 3,469 |
Short-term lease cost | 515 | 1,542 | 1,154 | 1,963 |
Variable lease cost | $ 211 | 364 | $ 592 | 611 |
Other income, net | ||||
Lease Cost | ||||
Sublease expense (income) | $ 6 | $ (114) |
Leases (Maturities of Operating
Leases (Maturities of Operating Lease Liabilities and lease payments) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Maturity of Lease Liabilities | ||
2021 (remaining) | $ 4,045 | |
2022 | 3,615 | |
2023 | 2,150 | |
2024 | 1,616 | |
2025 | 1,033 | |
Thereafter | 0 | |
Total lease payments | 12,459 | |
Less: Present value discount | (1,009) | |
Total operating lease liabilities | $ 11,450 | $ 14,932 |
Accounts Payable, Accrued Exp_3
Accounts Payable, Accrued Expenses and Other Liabilities (Schedule of Accounts Payable and Accrued Liabilities) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Accounts payable | $ 15,092 | $ 15,092 | $ 24,594 | |||
Accrued employee compensation | 20,407 | 20,407 | 27,154 | |||
Accrued contracted services | 46,026 | 46,026 | 62,425 | |||
Accrued restructuring | 0 | 0 | 2,504 | |||
Accrued rebates, discounts and other incentives | 41,247 | 41,247 | 38,172 | |||
Operating lease liabilities | 6,127 | 6,127 | 7,248 | |||
Other liabilities | 8,345 | 8,345 | 8,942 | |||
Accounts payable, accrued expenses and other liabilities | 137,244 | 137,244 | 171,039 | |||
Europe [Member] | ||||||
Accrued rebates, discounts and other incentives | 32,100 | 32,100 | $ 27,400 | |||
Her Majesty's Revenue and Customs (HMRC) [Member] | Foreign Tax Authority [Member] | ||||||
Research and development expense, decrease | $ 22,000 | $ 22,000 | ||||
Her Majesty's Revenue and Customs (HMRC) [Member] | Foreign Tax Authority [Member] | Tax Year 2017 [Member] | ||||||
Tax credit from research and developement | $ 9,400 | $ 9,400 | $ 9,400 | |||
Research and development expense, decrease | $ 9,400 | 10,700 | 10,700 | |||
Her Majesty's Revenue and Customs (HMRC) [Member] | Foreign Tax Authority [Member] | Tax Year 2018 [Member] | ||||||
Deferred income tax liability | $ 4,200 | $ 4,200 | ||||
SME scheme [Member] | Her Majesty's Revenue and Customs (HMRC) [Member] | Foreign Tax Authority [Member] | ||||||
Percentage of credit eligible from tax authority | 33.40% | |||||
RDEC scheme [Member] | Her Majesty's Revenue and Customs (HMRC) [Member] | Foreign Tax Authority [Member] | ||||||
Percentage of credit eligible from tax authority | 12.00% |
Long-Term Debt (Narrative) (Det
Long-Term Debt (Narrative) (Details) | May 14, 2019USD ($)$ / shares | Jul. 06, 2016USD ($)$ / shares | Jun. 30, 2021USD ($)item | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Jun. 30, 2016$ / shares |
Payments for capped call transactions and associated costs | $ 38,400,000 | |||||
Cap price of capped call transaction | $ / shares | $ 262.2725 | |||||
Long-term debt | $ 575,815,000 | $ 560,582,000 | ||||
Convertible Debt [Member] | ||||||
Debt Related Commitment Fees and Debt Issuance Costs | 19,000,000 | |||||
Cash payments for interest | 9,800,000 | $ 9,800,000 | ||||
Interest payable, current | 8,100,000 | 8,100,000 | ||||
Debt issuance costs | $ 9,300,000 | 10,700,000 | ||||
Convertible Senior Notes 3.25% Due 2023 [Member] | Convertible Debt [Member] | ||||||
Debt instrument, face amount | 460,000,000 | |||||
Debt instrument, interest rate, stated percentage | 3.25% | |||||
Proceeds from convertible debt | 447,600,000 | |||||
Debt Related Commitment Fees and Debt Issuance Costs | $ 12,400,000 | |||||
Debt instrument convertible, percentage of conversion price | 130.00% | |||||
Average percentage of closing sale price of common stock | 98.00% | |||||
Debt instrument, convertible, conversion ratio | 5.0358 | |||||
Debt instrument, convertible, conversion price | $ / shares | $ 198.58 | |||||
Percentage of repurchase price is equal to principal amount of convertible notes | 100.00% | |||||
Debt instrument liability component effective interest rate | 8.40% | |||||
Long-term debt | $ 334,400,000 | |||||
Debt instrument, unamortized discount, noncurrent | 113,100,000 | |||||
Fair value of the Convertible Notes | $ 415,800,000 | 363,700,000 | ||||
Convertible Senior Notes 3.25% Due 2023 [Member] | Convertible Debt [Member] | One Hundred Thirty Percent Applicable Conversion Price [Member] | Maximum [Member] | ||||||
Debt instrument convertible consecutive trading days | 30 | |||||
Convertible Senior Notes 3.25% Due 2023 [Member] | Convertible Debt [Member] | One Hundred Thirty Percent Applicable Conversion Price [Member] | Minimum [Member] | ||||||
Debt instrument convertible consecutive trading days | 20 | |||||
Convertible Senior Notes 3.25% Due 2023 [Member] | Convertible Debt [Member] | Ninety Eight Percent Applicable Conversion Price [Member] | ||||||
Debt instrument convertible consecutive trading days | item | 5 | |||||
Convertible Senior Notes 2.00% Due 2026 [Member] | Convertible Debt [Member] | ||||||
Debt instrument, face amount | $ 230,000,000 | |||||
Debt instrument, interest rate, stated percentage | 2.00% | |||||
Proceeds from convertible debt | 223,400,000 | |||||
Debt Related Commitment Fees and Debt Issuance Costs | $ 6,600,000 | |||||
Debt instrument convertible, percentage of conversion price | 130.00% | |||||
Average percentage of closing sale price of common stock | 98.00% | |||||
Debt instrument, convertible, conversion ratio | 9.2123 | |||||
Debt instrument, convertible, conversion price | $ / shares | $ 108.55 | |||||
Percentage of repurchase price is equal to principal amount of convertible notes | 100.00% | |||||
Debt instrument liability component effective interest rate | 9.90% | |||||
Long-term debt | $ 137,500,000 | |||||
Debt instrument, unamortized discount, noncurrent | 85,900,000 | |||||
Underwriting discounts and estimated offering expenses | 6,600,000 | |||||
Equity issuance cost | 2,500,000 | |||||
Debt issuance costs | 4,100,000 | |||||
Fair value of the Convertible Notes | $ 158,100,000 | $ 142,800,000 | ||||
Convertible Senior Notes 2.00% Due 2026 [Member] | Convertible Debt [Member] | One Hundred Thirty Percent Applicable Conversion Price [Member] | Maximum [Member] | ||||||
Debt instrument convertible consecutive trading days | 30 | |||||
Convertible Senior Notes 2.00% Due 2026 [Member] | Convertible Debt [Member] | One Hundred Thirty Percent Applicable Conversion Price [Member] | Minimum [Member] | ||||||
Debt instrument convertible consecutive trading days | 20 | |||||
Convertible Senior Notes 2.00% Due 2026 [Member] | Convertible Debt [Member] | Ninety Eight Percent Applicable Conversion Price [Member] | ||||||
Debt instrument convertible consecutive trading days | item | 5 |
Long-Term Debt (Schedule of Lon
Long-Term Debt (Schedule of Long-term Debt Instruments and Interest Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Long-term debt, gross | $ 690,000 | $ 690,000 | $ 690,000 | ||
Less: Unamortized debt discounts and fees | (114,185) | (114,185) | (129,418) | ||
Long-term Debt, Total | 575,815 | 575,815 | 560,582 | ||
Long-term debt outstanding | 575,815 | 575,815 | 560,582 | ||
Interest Expense, Long-term Debt [Abstract] | |||||
Contractual interest expense | 4,888 | $ 4,888 | 9,775 | $ 9,775 | |
Amortization of debt discount | 7,016 | 6,417 | 13,877 | 12,693 | |
Amortization of debt issuance costs | 685 | 628 | 1,356 | 1,242 | |
Total interest expense | 12,589 | $ 11,933 | 25,008 | $ 23,710 | |
Convertible Senior Notes 3.25% Due 2023 [Member] | |||||
Long-term debt, gross | 460,000 | 460,000 | 460,000 | ||
Convertible Senior Notes 3.25% Due 2023 [Member] | Convertible Debt [Member] | |||||
Long-term debt outstanding | 334,400 | 334,400 | |||
Convertible Senior Notes 2.00% Due 2026 [Member] | |||||
Long-term debt, gross | 230,000 | 230,000 | $ 230,000 | ||
Convertible Senior Notes 2.00% Due 2026 [Member] | Convertible Debt [Member] | |||||
Long-term debt outstanding | $ 137,500 | $ 137,500 |
Product Revenue, Net (Narrative
Product Revenue, Net (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Product revenue, net | $ 96,576 | $ 77,249 | $ 178,237 | $ 149,901 |
Product [Member] | ||||
Product revenue, net | $ 96,576 | $ 77,249 | $ 178,237 | $ 149,901 |
Product Revenue, Net (Schedule
Product Revenue, Net (Schedule of Product Revenue, Net) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Product revenue, net | $ 96,576 | $ 77,249 | $ 178,237 | $ 149,901 |
Product [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue, net | 96,576 | 77,249 | 178,237 | 149,901 |
Product [Member] | United States [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue, net | 68,178 | 59,629 | 125,477 | 110,408 |
Product [Member] | Non-US [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue, net | $ 28,398 | $ 17,620 | $ 52,760 | $ 39,493 |
Product Revenue, Net (Allowance
Product Revenue, Net (Allowance for credit losses) (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Allowance for credit losses, Rollforward | |
Balance at the beginning of period | $ 235 |
Provision for credit losses | 82 |
Write-offs | (38) |
Balance at the end of period | $ 279 |
Research and Development Tax _2
Research and Development Tax Credit (Narrative) (Details) - Her Majesty's Revenue and Customs (HMRC) [Member] - Foreign Tax Authority [Member] - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Research and development expense, decrease | $ 22 | $ 22 | |||
Tax Year 2017 [Member] | |||||
Research and development expense, decrease | $ 9.4 | $ 10.7 | $ 10.7 | ||
Research and development expense decrease, foreign currency translation | $ 1.3 | $ 1.3 | |||
Tax credit from research and developement | $ 9.4 | $ 9.4 | $ 9.4 | ||
SME scheme [Member] | |||||
Percentage of credit eligible from tax authority | 33.40% | ||||
RDEC scheme [Member] | |||||
Percentage of credit eligible from tax authority | 12.00% |
Restructuring Expenses (Narrati
Restructuring Expenses (Narrative) (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Sep. 30, 2020employee | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | |
Restructuring Expenses | |||||
Workforce reduction percent | 25.00% | ||||
Workforce reduction number of employees | employee | 170 | ||||
Restructuring charges | $ 249 | $ 0 | $ 88 | $ 0 | |
Restructuring costs accumulated | $ 14,500 | $ 14,500 |
Restructuring Expenses (Schedul
Restructuring Expenses (Schedule of restructuring activities) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring benefits | $ (249) | $ 0 | $ (88) | $ 0 |
Employee Compensation Restructuring Cost [Member] | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring benefits | $ (249) | (92) | ||
Employee Equity Compensation Restructuring Cost [Member] | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring costs | $ 4 |
Restructuring Expenses (Sched_2
Restructuring Expenses (Schedule of restructuring rollforward) (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Restructuring Expenses | |
Accrued balance , Beginning Balance | $ 2,504 |
Charges incurred | 180 |
Cash payments made | (2,104) |
Other reserve adjustments | (580) |
Accrued balance , Ending Balance | $ 0 |
Stock Compensation (Narrative)
Stock Compensation (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2021 | Oct. 31, 2012 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 |
Granted - Number of Shares | 1,197,000 | |||||
Granted - Weighted Average Fair Value | $ 28.27 | |||||
Net proceeds from exercise of stock options | $ 18 | $ 731 | $ 18 | $ (1,052) | ||
Granted - Shares | 940,000 | |||||
Forfeited | 309,000 | |||||
2012 Stock Plan [Member] | ||||||
Additional shares available | 1,211,533 | 555,843 | ||||
Stock Options [Member] | ||||||
Share-based compensation not yet recognized | 33,500 | $ 33,500 | ||||
Share-based compensation not yet recognized, period | 1 year 6 months 25 days | |||||
Restricted and Performance Stock Units and Awards [Member] | ||||||
Share-based compensation not yet recognized, other than options | 44,600 | $ 44,600 | ||||
Share-based compensation not yet recognized, period | 1 year 7 months 24 days | |||||
Performance Stock Units and Awards [Member] | ||||||
Performance period | 3 years | |||||
Share based compensation expenses | $ 400 | $ 900 | ||||
Performance Stock Units and Awards [Member] | Minimum [Member] | ||||||
Payout percentage, as percent of target award | 0.00% | 0.00% | ||||
Performance Stock Units and Awards [Member] | Maximum [Member] | ||||||
Payout percentage, as percent of target award | 150.00% | 150.00% | ||||
Performance Stock Units (PSUs) [Member] | ||||||
Shares granted during period for stock based compensation | 176,794 | |||||
Forfeited | 34,000 |
Stock Compensation (Schedule of
Stock Compensation (Schedule of Share Based Compensation Arrangement By Share Based Payment Award Grants in Period Fair Value Assumptions) (Details) - Stock Options [Member] | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Volatility, minimum | 65.20% | 61.90% |
Volatility, maximum | 67.70% | 87.10% |
Risk-free interest rate, minimum | 0.40% | 0.30% |
Risk-free interest rate, maximum | 0.90% | 1.70% |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 6 months | 5 years 6 months |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years | 6 years |
Stock Compensation (Schedule _2
Stock Compensation (Schedule of Share Based Compensation Stock Options Activities) (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | |
Stock Compensation [Abstract] | ||
Beginning Outstanding, Number of Shares | shares | 2,199 | |
Granted - Number of Shares | shares | 1,197 | |
Exercised - Number of Shares | shares | (2) | |
Forfeited - Number of Shares | shares | (313) | |
Expired - Number of Shares | shares | (291) | |
Ending Outstanding, Number of Shares | shares | 2,790 | 2,199 |
Expected to vest - Number of shares | shares | 1,452 | |
Exercisable - Number of Shares | shares | 1,337 | |
Beginning Outstanding, Weighted Average Exercise Price | $ / shares | $ 96.92 | |
Granted - Weighted Average Exercise Price | $ / shares | 26.85 | |
Exercised - Weighted Average Exercise Price | $ / shares | 8.67 | |
Forfeited - Weighted Average Exercise Price | $ / shares | 61.87 | |
Expired - Weighted Average Exercise Price | $ / shares | 103.39 | |
Ending Outstanding, Weighted Average Exercise Price | $ / shares | 70.18 | $ 96.92 |
Expected to vest - Weighted Average Exercise Price | $ / shares | 43.43 | |
Exercisable - Weighted Average Exercise Price | $ / shares | $ 99.24 | |
Options Outstanding - Weighted Average Remaining Life | 7 years 7 months 6 days | 6 years 10 months 24 days |
Expected to vest - Weighted Average Remaining Term | 9 years 3 months 18 days | |
Exercisable - Weighted Average Remaining Term | 5 years 9 months 18 days | |
Options Outstanding - Aggregate Intrinsic Value | $ | $ 439 | $ 146 |
Expected to vest - Aggregate Intrinsic Value | $ | 439 | |
Exercisable - Aggregate Intrinsic Value | $ | $ 0 |
Stock Compensation (Schedule _3
Stock Compensation (Schedule of Share-based Compensation, Restricted Stock Units and Award Activity) (Details) shares in Thousands | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Stock Compensation [Abstract] | |
Outstanding, December 31, 2019 | shares | 799 |
Granted - Shares | shares | 940 |
Vested - Shares | shares | (125) |
Forfeited - Shares | shares | (309) |
Outstanding, September 30, 2020 | shares | 1,305 |
Outstanding - Weighted Average Fair Value, December 31, 2019 | $ / shares | $ 72.43 |
Granted - Weighted Average Fair Value | $ / shares | 28.27 |
Vested - Weighted Average Fair Value | $ / shares | 60.92 |
Forfeited - Weighted Average Fair Value | $ / shares | 63.66 |
Outstanding - Weighted Average Fair Value, September 30, 2020 | $ / shares | $ 44.06 |
Stock Compensation (Schedule _4
Stock Compensation (Schedule of Stock Based Compensation Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated stock-based compensation | $ 8,448 | $ 16,083 | $ 16,867 | $ 28,556 |
Selling, General and Administrative Expenses [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated stock-based compensation | 7,300 | 12,249 | 13,689 | 21,972 |
Research and Development Expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated stock-based compensation | 1,148 | 3,834 | 3,174 | 6,584 |
Restructuring Charges [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Allocated stock-based compensation | $ 0 | $ 0 | $ 4 | $ 0 |
Net Loss Per Share (Schedule of
Net Loss Per Share (Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share) (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive securities excluded from computation of earnings per share, amount | 8,375 | 7,706 | 8,382 | 7,820 |
Convertible Notes [Member] | ||||
Antidilutive securities excluded from computation of earnings per share, amount | 4,435 | 4,435 | 4,435 | 4,435 |
Stock Options [Member] | ||||
Antidilutive securities excluded from computation of earnings per share, amount | 2,729 | 2,422 | 2,727 | 2,492 |
Restricted Stock Units (RSUs) [Member] | ||||
Antidilutive securities excluded from computation of earnings per share, amount | 1,211 | 849 | 1,220 | 893 |